Electrical Safety

Almost every workplace uses electricity as its main source of energy. Working around electricity can cause significant injuries and even death, known ...

Bloodborne Pathogens -- General Industry

Employees who are regularly exposed to bloodborne pathogens run the risk of contracting serious diseases due to that exposure. This course ...

Bloodborne Pathogens -- Healthcare Workers

This course provides an overview of bloodborne pathogens in the healthcare setting. After completing this course, participants will be able to ...

Driver Safety Program (DSP)

Traffic accidents injure and kill thousands of people each year. The majority of these accidents could have been prevented. This course identifies ...

Fire Safety for Healthcare Workers

Fire safety in healthcare facilities is especially crucial because employees are not just keeping themselves safe. They’re responsible for the ...

Postmarketing Reporting of Adverse Drug Experiences

This course explores the process for reporting postmarketing adverse drug experiences to FDA. Topics in this course include: Reports and ...

Documenting the Drug Development Process — ICH Q8(R2)

FDA issued the International Conference on Harmonization (ICH) guidance Q8(R2) Pharmaceutical Development. This guidance addresses documenting the ...

Medicare Part D: Bid and Benefit Package

<p>This course explains the benefits available to individuals who are eligible for Part D and presents the requirements for bidding to become ...

Hot Work Permits

Hot work must be performed in a way that ensures the safety of all employees performing hot work in non-protected areas, where protection from high ...

Q9: Quality Risk Management

This course introduces the definition and principles of quality risk management (QRM) and the basic steps of a typical QRM process. Topics in this ...

The Clinical Development Process: Investigational Product, Plan, and Data Management

This course will discuss the clinical development process, including the regulatory obligations of the sponsor of a new drug or product. Topics in ...

FDA Establishment Inspection (EI)

FDA performs approximately 15,000 establishment inspections (EIs) per year. Topics in this course include: FDA Authority, Preparation, Initiating ...

Introduction to Medical Device Health Care Compliance

This course provides an introduction regarding the compliance of pertinent laws, regulations, and guidance that regulate the medical device industry. ...

Combustible and Flammable Liquids

Combustible and flammable liquids are often the root cause of many fires and explosions in the workplace. This course describes safety precautions ...

Computer Workstation Safety

Computer workstations can be a source of nagging and debilitating Repetitive Stress Injuries (RSIs). This course addresses causes and symptoms of ...

Ergonomics: Body Mechanics and Fitness

This course discusses the importance of workplace ergonomics and body mechanics in maintaining health and preventing injury while on the job. Topics ...

Guidelines of Workplace Safety

This course explains how both employees and employers uphold safety in the workplace. Topics in this course include: Causes of Accidents, Accidents ...

Managing Conflict

As workforce numbers shrink, and individuals are called to interact more intensely with fewer people, the ability to manage conflict effectively ...

Active Listening Skills

Listening is one of the most important skills for success in life, but it is taken for granted by most people. This course describes how to improve ...

Privacy and Data Protection

<p>This course describes your responsibility for protecting any personal information that is under your control. Topics in this course ...

Foreign Corrupt Practices Act (FCPA)

This course explores the Foreign Corrupt Practices Act (FCPA) and anti-bribery. It discusses the laws, regulations, and policies associated with ...

Making Ethical Decisions

The purpose of this training is to help you become a better decision maker when faced with ethics situations. You will recognize how to identify and ...

Doing the Right Thing: Anti-bribery

<p>This course provides basic training on complying with laws prohibiting bribery, including the US Foreign Corrupt Practices Act (FCPA). ...

Handling Confidential Information

This course explores the importance of protecting confidential information in order to preserve privacy and maintain a competitive edge. After ...

Recognizing and Avoiding Conflicts of Interest

This course provides an overview of conflicts of interest, and also provides guidance and reporting mechanisms for conflicts of interest. Learners ...

Safeguarding Intellectual Property

This course discusses how to identify and protect the Intellectual Property (IP) assets of a company. It also covers the four primary types of ...

Detecting and Preventing Fraud

This course will identify what constitutes fraud, how to recognize and report potential or actual fraud, and when and how you should report it. After ...

E-Mail and Corporate Communications

E-mail remains the predominant form of communication in the business world, with estimates ranging in excess of 100 billion e-mails sent and received ...

Doing the Right Thing for Customers and Business Partners

Businesses must be able to demonstrate that they can run their business with integrity and keep their promises. This course explores how to build ...

Section 1557 of the Affordable Care Act

This course discusses the requirements of Section 1557 of the Affordable Care Act. After completing this course, learners will be able to identify ...

Medicare Advantage: Administration and Management

This course provides information on the administrative infrastructure and management capabilities required of all Medicare Advantage Organizations ...

Medicare Advantage: Membership Services

<p><span style="font-weight:normal;">This course discusses the obligations of a Medicare Advantage Organization (MAO) and of the Centers ...

Quality Systems Approach

This course explains FDA’s guidance on a modern quality systems approach to pharmaceutical manufacturing. Topics in this course include: FDA’s ...

Hazardous Waste Disposal

Industries operating in the US must track all hazardous wastes from generation to disposal and beyond. The US Environmental Protection Agency (EPA) ...

HAZWOPER Awareness

<p>The exposure to hazardous chemicals is a risk faced by Americans in workplaces every day. This course identifies hazardous substances that ...

Medicare Advantage: Claims Processing

<p>This course explores the Centers for Medicare and Medicaid Services (CMS) regulations and instructions for the processing of Part C ...

Medicare Advantage: Provider Networks

<p>This course examines provider networks and the tools associated with their development. It includes an in-depth look at tools that are ...

Medicare Advantage: Quality Management and Utilization Management

<p>This course describes the Quality Improvement (QI) regulatory requirements for a Medicare Advantage Organization (MAO). Topics in this ...

MAPD/PDP: Communications and Marketing

<p>This course examines what types of communication materials are regulated, what must be included in the materials and what is prohibited, ...

MAO/PDP: Compliance Program Guidelines

Effective compliance programs are a requirement for Medicare Advantage Organizations (MAO) and Medicare Prescription Drug Plans (PDP) that contract ...

Special Needs Plans: Model of Care

The Model of Care (MOC) is considered a vital quality improvement tool and integral component for ensuring that the unique needs of each beneficiary ...

Medicare Part D: Coordination of Benefits and True Out-of-Pocket Facilitation

<p><span>This course examines the procedures required by the Centers for Medicare and Medicaid Services (CMS) that Part D sponsors ...

Emergency Preparation, Recognition, Control, Communication, and Response

An emergency response is carried out when the safety of humans and the environment are at risk. This course addresses how to plan, prepare for, ...

Emergency Response: Hazardous Spill

This course is designed for emergency response personnel who will serve in the Operations Section of the Incident Command System. After completing ...

Incident Command System: Structure and Components

The Incident Command System (ICS) provides the framework to manage the emergency response effort, while ensuring the safety of responders, the ...

Incident Command System: Responsibilities

The preceding course, OSHA77, Incident Command System: Structure and Components, addresses the structure and major components of the Incident Command ...

Safety Hazards and Equipment

This course emphasizes that knowledge combined with awareness equal safety. After completing this course, the learner will be able to identify safety ...

Spill Prevention and Response Procedures

This course addresses the importance of spill prevention and the procedures involved in responding to spills. After completing this course, the ...

Drugs and Alcohol: Agencies and Laws

The Department of Transportation is responsible for maintaining public health and safety through prevention of alcohol and drug abuse in the ...

Drugs and Alcohol: General Information

The effects of drug and alcohol abuse cause many injuries and even deaths every year, and the costs to employers are enormous. This course, the ...

Drugs and Alcohol: General Testing Information

Testing for drugs and alcohol in the workplace is a progressive step to protect employees and the public from the tragic consequences of substance ...

Drugs and Alcohol: Testing and Collection Procedures for Managers and Supervisors

This course, the last in a four-part series, covers the details of testing and collection procedures for managers and supervisors who are responsible ...

QSIT 1 -- Beginning the Inspection

This is the first in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). This course provides guidance for ...

QSIT 2 -- The Management Controls Subsystem

This is the second in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). This course will cover the ...

QSIT 3 -- The Design Controls Subsystem

This is the third in the a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). This course will explain the ...

QSIT 4 -- The Corrective and Preventive Actions Subsystem

This is the fourth in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for ...

QSIT 5 -- The Production and Process Controls Subsystem

This is the fifth in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for ...

Systems Based Drug Inspections

FDA has a series of compliance programs that provide guidance and instructions to help meet FDA regulations for pharmaceutical manufacturers. This ...

ICH Q7A: Introduction and Quality Management

This is the first in a series of courses designed to instruct on current good manufacturing practices (GMPs) for active pharmaceutical ingredients ...

Part 11: Electronic Records and Signatures -- Changes in Enforcement Policy

Since the inception of Part11, FDA has issued changes to the enforcement policy for electronic records and signatures. This course describes how to ...

Part 11: Electronic Records and Signatures -- Application

In many organizations today, electronic records and electronic signatures are becoming more common. This course identifies how to implement Part 11 ...

Part 11: Electronic Records; Electronic Signatures

In many industries today, the use of electronic records and signatures is becoming more common. This course explains the purpose of 21 CFR Part 11. ...

Computerized Systems Inspections in the Medical Device Industry

This course has been designed to assist FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry. ...

Auditing of Computer System Validation to Ensure Data Integrity

FDA inspectors and corporate auditors must be able to recognize the critical aspects of computerized systems and the documentation needed to ...

Preventing Sexual Harassment

<p><span style="font-size:10pt;">You have a responsibility to yourself and your co-workers to take action when faced with sexual ...

Discrimination and Harassment Free Workplace

<p>Each of us is responsible for our working environment. Every employee needs to understand the kind of behavior that fosters a positive and ...

Physical and Network Security

Information security is critical for any business. This course identifies the types of assets that are at risk, outlines methods to protect them, and ...

Age Discrimination

Age discrimination can be particularly challenging when an employer is reducing employee numbers or is managing an aging workforce. This course ...

Affirmative Action in the Workplace (For Employers)

Today, federal laws make it illegal to discriminate against a job applicant or an employee because of the person's race, color, religion, sex, ...

Fair Labor Standards Act (FLSA) and Equal Pay Act (EPA)

<p>The Fair Labor Standards Act (FLSA) is a federal law that establishes minimum wage, overtime pay, recordkeeping, and youth employment ...

ICH Q7: Resources and Materials Management

This is the second in a series of courses designed to instruct on Good Manufacturing Practices (GMPs) for Active Pharmaceutical Ingredients (APIs), ...

Change Control

The control of change is very important in the regulated industries of drug products, biologics, and medical devices. Changes to processes, material, ...

Introduction to GMPs

Current Good Manufacturing Practices (cGMPs) are specific requirements that ensure safe manufacturing of pharmaceutical products and medical devices. ...

Care and Handling of Drug Product Components, Labeling, Containers, and Closures

It is crucial to understand and follow cGMP regulations related to components, labeling, containers, and closures of drug products. This course ...

Understanding Post-Approval Changes

FDA has made a number of recent changes to its regulations concerning post-approval manufacturing changes for drug products. This course covers ...

Resolving Out Of Specification Test Results

Obtaining an out of specification test result can be unsettling, and it is important that you know what to do with it. This course will provide you ...

Conducting Annual Product Reviews

This course identifies regulations for manufacturers conducting annual reviews of pharmaceutical products. Topics in this course include: APR ...

Batch Record Reviews

Pharmaceutical batch records are essential to ensure that regulatory and product quality attributes are achieved. This course describes how to ...

GMP Principles of SOPs

Working within SOPs is critical to making high-quality products that comply with FDA regulations. This course describes the basic GMP principles ...

Awareness of FDA Inspections for Pharmaceutical Manufacturers

This course covers the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations ...

FDA Training and Qualification Requirements

Effective personnel training and qualification can produce a competent workforce, which can lead to a reduction of errors/deviations, customer ...

Corrective and Preventive Actions

Corrective and preventive actions (CAPA) can prevent continuing production problems, high scrap rates, product failures, customer dissatisfaction, ...

Pre- and Post-Approval FDA Drug Inspections

This course will explore pre-approval and post-approval drug FDA inspections. Specifically, the purpose and focus of each type of inspection will be ...

Failure Investigations for Pharmaceutical Manufacturers

An effective system for conducting failure investigations can provide a means for preventing recurrences. This course will familiarize the learner ...

GMP Principles for Batch Records

This course explains the Good Manufacturing Practices associated with batch records. Topics in this course include: Record Requirements, ...

Handling an FDA Inspection

This course addresses the roles and responsibilities of personnel during an FDA inspection. Topics in this course include Personnel Conduct, ...

Essentials of an Effective Calibration Program

Injuries, fatalities, or major class action suits filed against the manufacturer can result when products are produced with out-of-calibration ...

Meeting GMP Training Requirements

In order to produce products that are pure, safe, effective, and in compliance with FDA regulations, it is necessary to understand the nature of GMP ...

Effectively Responding to FDA 483s and Warning Letters

No company wants to receive an FDA 483 or Warning Letter for adverse findings after an FDA inspection, but it does happen. This course explains the ...

Pharmaceutical and Medical Device Supplier Quality Management

A growing list of unsafe, counterfeit, contaminated, and defective products has emphasized the need for increased supplier quality management. This ...

GMP Updates: Supply Chain Quality and Emerging Compliance Concerns

Supply chain activities provide the natural resources and raw materials that manufacturers transform into a finished product. This course describes ...

Combination Products – cGMP Requirements

FDA has issued a regulation on the current good manufacturing practice (cGMP) requirements applicable to combination products in an effort to improve ...

European Union GMP Requirements for Computerised Systems

This course introduces the European Union’s GMP requirements for computerised systems that are associated with the manufacture of medicinal products. ...

EU Directives and Inspection Readiness

The EU has strict requirements for the manufacture and supply of medicinal products, which are defined in EU directives and GMP guides. To confirm ...

Management Responsibility for Quality: What FDA Expects

Under FDA law and regulations, an effective and compliant Quality System literally begins and ends with management. This course explains who is ...

Role of the Qualified Person

The role of the Qualified Person (QP) is defined in European Union legislation. This course explains the release of medicinal products to the market, ...

European Union Good Distribution Practices for Medicinal Products

<p>This course describes the Good Distribution Practices required by the European Union (EU). The EU’s recommended practices are similar to ...

European Union GMP Requirements

If you are involved with the manufacture of medicinal products you must comply with Good Manufacturing Practice (GMP) requirements. This course ...

Validation of Analytical Laboratory Procedures

This course introduces developers and those individuals involved in validation of analytical methods to the regulatory requirements for the ...

Data Integrity for Quality Control Laboratories

To ensure the quality of raw materials, in-process materials, and finished goods, laboratory data integrity is of great importance in current Good ...

Good Documentation Practices for Medical Device Manufacturers

This course presents the critical importance of creating and maintaining good documents for medical device manufacturers. Learners will identify the ...

FDA 483s: Inspectional Observations

This course is designed to familiarize FDA staff with the important aspects of the FDA 483. Topics in this course include: FDA 483, Objectionable ...

Risk Management in Pharmaceutical Manufacturing

This course covers the practical application of risk management principles, published in “Guidance for Industry: Q9 Quality Risk Management”, through ...

Pharmaceutical Risk Management: Picking the Right CAPA Tools

Any failure of a batch or its components to meet any of its specifications must be thoroughly investigated, whether or not the batch has already been ...

How to Meet Drug Retention and Stability Testing Requirements

This course is designed to provide the learner with an understanding of the principles of drug stability testing and requirements for maintaining ...

An Introduction to ISO 13485 - The Quality Management System for Medical Devices

The international standard ISO 13485:2016 specifies the requirements for a quality management system that can be used by an organization in one or ...

A Guide to ISO 13485 - The Quality Management System for Medical Devices

This course serves as a guide to ISO 13485 — the international quality management system standard for medical devices. The requirements of the ...

Principles of Good Documentation

Documentation is an essential part of Good Manufacturing Practice (GMP). This course provides an overview for manufacturers of pharmaceutical and ...

Diversity in the Workplace

The increasing diversity of today’s workforce means that employees and supervisors are part of a dynamic and ever-changing environment. This course ...

Family and Medical Leave Act (FMLA)

Managers and supervisors in the workplace must fully understand the federal Family and Medical Leave Act (FMLA). This course explains who is covered ...

Sexual Harassment Awareness for Employees

<p>Sexual harassment is a serious issue facing employers. This course is designed to educate you about the Equal Employment Opportunity ...

Sexual Harassment Awareness for Managers

<p>This course presents an overview of sexual harassment and emphasizes the specific responsibilities of managers and supervisors in preventing ...

Substance Abuse

Employee substance abuse is one of the most troubling issues facing modern businesses. This course discusses substance abuse as it affects both the ...

Violence in the Workplace

Disputes between employees, or between employees and their supervisors, are not unusual in a stressful workplace environment. Occasionally, conflicts ...

Confidentiality, Intellectual Property Protection, and Information Security

Every day, employees may come into contact with information that must be protected. In order to preserve the confidentiality, integrity, and ...

Harassment in the Workplace

<p>Harassment is a serious issue facing companies today. This course identifies what constitutes harassment and outlines the best practices ...

Harassment Avoidance Training for California

Supervisors and managers must take all complaints and incidents of sexual harassment seriously and should respond quickly and appropriately. This ...

Safe Driving

This course provides critical information on pre-trip safety inspections, highway, city, and town driving, how to drive in inclement winter weather, ...

Preventing Back Injuries

This course will provide information crucial to the identification, prevention, and treatment of back injuries and any associated complications.

Laboratory Safety

This course introduces the learner to the principles and practices that help make the laboratory a safe working environment. This course emphasizes ...

Access to Employee Exposure and Medical Records

Employers must keep medical or exposure records for all employees who have been exposed to a hazardous substance in the workplace. This course ...

Office Safety

Hidden dangers lurk in every corner of a workplace. With potential hazards ranging from fire to personal injury, knowing how to identify hazards and ...

PPE Assessment

Thousands of workers suffer injuries each year. In many cases, these injuries could have been prevented by wearing appropriate personal protective ...

Process Safety Management: Overview

Unexpected releases of toxic, reactive, and flammable liquids and gases have caused great harm and numerous deaths. Such events underscore the need ...

Safety Signs and Color Codes

Being able to recognize and understand safety signs and color codes are essential in performing work safely, effectively, and efficiently. This ...

Scaffold Safety

This course focuses on preventing fatalities and serious injuries when using scaffolds. Consistent work practices are identified that should be ...

Walking and Working Surfaces — Affected Person

This course discusses accident prevention and the general requirements for walking and working surfaces. Topics in this course include: Causes and ...

National Patient Safety Goals

This course focuses on best practices and safety goals for Healthcare Industry Representatives (HCIR). This course will help you identify the need ...

Basics of PhRMA Code

For members of PhRMA to reaffirm their commitment to following the highest ethical standards as well as all legal requirements while promoting ...

Medical Education for Healthcare Professionals

Pharmaceutical companies contract with healthcare professionals to assist them in conducting market research, perform clinical trials, or endorse a ...

Antitrust Law and Competitor Relationships

<p>Federal antitrust laws are designed to ensure that the basic promise of a free market economy and effective competition is not undermined by ...

Code of Business Conduct

All employees need to be aware of their companies Code of Business Conduct. This course describes the Code of Business Conduct and basic ethical ...

Basics of the AdvaMed Code

It is crucial for all Medical Technology companies to understand the guidelines of the Advanced Medical Technology Association (AdvaMed) Code and how ...

Reporting Adverse Events for Medical Devices

This course introduces the process for filing medical device reports (MDRs) for adverse events and identifies the different types of reports used.

Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation (Mass. Code) and Similar State-Level Requirements

<p>The Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation (Mass. Code) imposes a number of restrictions on ...

MedTech Europe Code of Ethical Business Practice

This course describes the MedTech Europe Code of Ethical Business Practice (the Code). Topics in this course include: General Criteria for Events, ...

Medical Device Filings: 510(k), PMA, and IDE

This course describes the premarket approval and notification processes for medical devices in the US. Topics in this course include: FDA ...

Sarbanes-Oxley Act: An Overview

The Sarbanes-Oxley Act of 2002 initiated the biggest change in corporate governance since the Great Depression. This course describes each section of ...

Global Anti-Bribery

This course introduces global anti-bribery laws and provides basic principles and specific guidelines for complying with anti-bribery laws around the ...

Global Fair Competition Laws

Fair competition laws help to preserve a level competitive playing field for companies. This course covers the basic principles and laws governing ...

Introduction to Pharmaceutical Compliance

This course introduces the agencies that govern standards of behavior in the pharmaceutical industry as well as the key requirements for compliant ...

Interactions with Healthcare Professionals - In-House

Pharmaceutical companies must ensure that any interactions with healthcare professionals are in compliance with internal and external guidelines, ...

Interactions with Healthcare Professionals - Field

This course covers the guidelines, rules, and regulations that govern interactions between field sales representatives and healthcare professionals.

Introduction to CFDA and CFDA Registration

This course introduces the basic structure of the China Food and Drug Administration (CFDA) and the process for approving medical devices in China.

Regulatory Requirements for Medical Devices in the Republic of Korea

This course covers the regulatory framework for medical devices in the Republic of Korea, recent and upcoming regulatory changes, and the medical ...

Principles of Cleaning Validation

The cleaning of equipment used in a pharmaceutical operation can be a complex process. Even the smallest amount of chemical residual material in ...

Understanding the Principles and Practices of Process Controls

Recently FDA has become increasingly concerned with the number of Warning Letters being issued due to problems with the control of manufacturing ...

Collecting Samples and Establishing Limits for Cleaning Validation

GMP regulations require that equipment used in the manufacturing of a drug, medical device, or biologic product be cleaned in such a way as to ensure ...

Documenting Validation Activities

The process of validation in FDA-regulated industry is important to gain FDA acceptance. The key to successful validation is the understanding that ...

Physician Payment Sunshine Act

After completing this course, you will be able to recognize the meaning and purpose of the Physician Payment Sunshine Act. You will also be able to ...

HIPAA and Privacy Guidelines for Medical Device Sales Representatives

It is important for Medical Device Sales representatives to know how our sensitivity to customers’ privacy concerns is critical to maintaining their ...

Principles of Sterilization

The success of sterilization can directly impact the quality and safety of products used by consumers. This course discusses the purpose of ...

Principles of Aseptic Processing

Because microbiological and particulate contamination can potentially cause serious health problems in animals and humans, it is vital that sterile ...

A Step-by-Step Approach to Process Validation

Process validation is required by process control regulations for both drugs and medical devices. This course outlines the important tasks performed ...

Key Concepts of Process Validation

Production problems can result in high scrap rates, product failures, customer dissatisfaction, and even death of a user. This course identifies the ...

Understanding GMPs for Facilities and Equipment

Facilities and equipment GMP requirements impact many aspects of plant operation — from setup to maintenance and cleaning. This course introduces the ...

Data Integrity: The Role of Quality Assurance for Data Integrity

Clinical trial data integrity has traditionally been an integral part of quality assurance. This course describes quality assurance in the light of ...

Data Integrity for Clinical Research Staff

Clinical research staff must be aware of the potential and inherent risks to data integrity. Topics in this course include: FDA Directions, Roles, ...

Review of Basic Statistical Techniques

The use of statistics in medical device manufacturing is now expected and regulated by the Food and Drug Administration in the Quality System ...

Risk Management 1: Key Concepts and Definitions

FDA manages risk in an attempt to prevent loss or injury by ensuring their medical devices, human and veterinary drugs, food additives, biologics, or ...

Requirements for Computerized Systems Validation and Compliance

This course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of ...

Approach to Computerized Systems Validation and Compliance

This course describes an approach to the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, ...

Computerized Systems Inspections in the Pharmaceutical Industry

This course explores how FDA personnel recognize the critical aspects of computerized systems in the pharmaceutical industry during Pre-Approval ...

A Tour of FDA

The Food and Drug Administration (FDA) touches the lives of virtually every American, every day. This course outlines the form and function of the ...

Biotechnology: An Overview of Compliance Considerations

This course provides an overview of the fundamental compliance issues impacting the biotechnology industry. Topics in this course include: ...

Application of GMPs to Analytical Laboratories

Compliance with current Good Manufacturing Practices (cGMP) requirements is essential in order to create products that have quality, purity, proper ...

The Design and Development of Software Used in Automated Process Controls

Regulators require that manufacturers apply the principles and practices of software quality assurance to automated systems that may ultimately ...

Application of GMPs to Microbiology Laboratories

<p>This course describes the general principles of current Good Manufacturing Practices (cGMPs) and their importance in microbiology ...

ISO 14971: Risk Management for Medical Devices

This course illustrates the application of risk management activities for medical device product safety through implementing the ISO 14971 ...

MAPD: Risk Adjustment and Data Validation

<p>This course identifies the principles and motivation for risk adjustment of capitation payments that the Centers for Medicare &amp; ...

ICH GCP Obligations of Investigators Conducting Clinical Trials

This course addresses the obligations of investigators as described by the International Conference on Harmonization of Technical Requirements for ...

Information Security

Information security is critical for any business, and it is the law for healthcare organizations. This course addresses training on the HIPAA ...

Deficit Reduction Act: False Claims and Employee Protections Training

This course covers the Deficit Reduction Act of 2005 (DRA) and provides awareness of the mandates and provisions that must be provided to employees ...

HP: Compliance Program General Session

The Office of Inspector General (OIG) guidance promotes Compliance Programs for all healthcare organizations. This course is designed to fulfill the ...

Fraud and Abuse Awareness

<p>Fighting fraud and abuse within a health plan is important, and associates are valuable assets in anti-fraud efforts. This course describes ...

Code of Conduct

Trust is the cornerstone of any long-term business relationship. Our responsibility is to earn that trust every day by acting in an ethically and ...

Introduction to Specialty Pharmacy Management

Specialty drugs are the fastest growing component of prescription drug expenditures because of enormous increases in availability and use, coupled ...

HIPAA: General Awareness

This course is designed to provide all employees and associates with an in-depth overview of the Health Insurance Portability and Accountability Act ...

HIPAA: Privacy Standards

Health plan members must be able to trust that shared information will be protected and remain confidential. This course provides an in-depth look at ...

Ethics as the Foundation to Clinical Research

All clinical research personnel confront ethical decisions. This course reviews the principles and methods that exist to ensure that the rights and ...

Informed Consent

The informed consent document and process are designed to serve as an ethical framework for safeguarding the rights and well-being of research ...

The Role of the Clinical Research Coordinator

The clinical research coordinator (CRC) has a key role in executing a clinical trial and acting as a liaison to the investigator, sponsor, and ...

Financial Disclosure by Clinical Investigators

This course provides a summary of Title 21 of the Code of Federal Regulations (CFR) Part 54 entitled “Financial Disclosure by Clinical ...

Administrative Roles of the Clinical Research Coordinator

This course describes the administrative roles and responsibilities of the Clinical Research Coordinator (CRC). The CRC is an individual who ...

Dietary Supplements -- Packaging, Labeling, Holding, and Distribution

This course discusses the requirements for dietary supplement product packaging, labeling, holding, and distribution.

Dietary Supplements -- Introduction to Part 111 cGMPs

The popularity of dietary supplements and the size of the global industry are increasing rapidly, and product safety has grown into a main concern. ...

Dietary Supplements -- cGMPS for Manufacturing Plants and Equipment

The Final Rule (21 CFR Part 111) defines the current Good Manufacturing Practices (cGMPs) for the Dietary Supplement industry, including specific ...

Dietary Supplements -- Production and Process Control System for Manufacturing Operations

This course is designed to help learners understand and recognize the principles and practices of process control and the role they play in ensuring ...

Dietary Supplements -- cGMP Requirements for Quality Control

This course provides information about regulatory requirements for Dietary Supplement manufacturers, holders, packagers and labelers during Quality ...

Dietary Supplements -- Requirements for Records and Recordkeeping

This course explains how GMP records and associated procedures remain effective and essential elements of maintaining product quality. Topics in this ...

Design Control Regulations for Medical Device Manufacturers

Manufacturers of medical devices are responsible for ensuring that the products they create follow the rules for design control. This course ...

Medical Device Packaging, Labeling, and Distribution

Mistakes or mix-ups in the critical areas of product packaging, labeling, and distribution can pose a danger to the consumer. This course provides ...

Quality Systems Inspection Technique (QSIT)

Manufacturing companies within the biomedical industry are subject to routine inspections of their quality systems by FDA. This course describes an ...

Introduction to the Quality System Regulation (QSR)

<p>Good Manufacturing Practices (GMPs) help protect medical devices and medical device users. This course describes the GMPs for medical ...

Failure Investigations for Medical Device Manufacturers

Handling medical device failures can be significant in a company’s ability to maintain a state of control in operations and prevent future failures. ...

Complaint Management for Medical Device Manufacturers

It is very important for manufacturers to properly respond to reports of alleged medical device problems. This course covers the FDA regulations for ...

Good Clinical Practices (GCPs) for New Product Investigations

<p>This course describes the general requirements of Good Clinical Practice (GCP) for new product investigations for the protection of human ...

Protection of Human Subjects in Clinical Trials

Protection of human subjects is the foremost and most important duty of investigators conducting clinical trials. This course will provide you with ...

CE Certification for Medical Devices

<p>This course describes information about compliance of medical devices in accordance with the European Medical Device Regulations (MDR). ...

High Purity Water Systems

Because water quality can directly impact product quality, GMP regulations require that water receive the same scrutiny, monitoring, and control as ...

QS Regulation 1: Overview and General Provisions

<p>This course introduces the Quality System (QS) Regulation (21 CFR Part 820) — a framework of basic requirements for manufacturers of ...

QS Regulation 2: Quality System Requirements

<p>The second in a series of Quality System (QS) Regulation courses, this course focuses on the management responsibility, quality auditing, ...

QS Regulation 3: Design Controls

<p>Based on regulatory authority and findings that a significant portion of device recalls were attributed to faulty design, FDA included ...

QS Regulation 4: Document and Purchasing Controls

<p>The fourth in a series of Quality System Regulation (QS Regulation) courses, this course focuses on the document controls requirements of ...

QS Regulation 5: Identification and Traceability; Production and Process Controls

<p>The fifth in a series of Quality System (QS) Regulation courses, this course focuses on Identification and Traceability (21 CFR Part 820, ...

QS Regulation 6: Acceptance Activities; Nonconforming Product

<p>The sixth in a series of Quality System (QS) Regulation courses, this course focuses on Acceptance Activities (21 CFR Part 820 Subpart H) ...

QS Regulation 7: Corrective and Preventive Action

The seventh in a series of Quality System (QS) Regulation courses, this course focuses on Corrective and Preventive Action (21 CFR Part 820 Subpart ...

QS Regulation 8: Labeling and Package Control; Handling, Storage, Distribution, and Installation

The eighth in a series of Quality System (QS) Regulation courses, this course focuses on Labeling and Package Control (21 CFR Part 820 Subpart K) and ...

QS Regulation 9: Records

The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. This course, the ninth in a series of ...

QS Regulation 10: Servicing; Statistical Techniques

<p>The Quality System (QS) regulation sets forth certain responsibilities for manufacturers relative to the servicing and statistical ...

QS Regulation 11: Application and Inspection of QS Regulation Requirements

The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. This course is the eleventh and final ...

Principles of Auditing

This course focuses on the purpose and conduct of internal and external quality audits. Topics in this course include: Scope, Types of Audits, ...

Operating Room Conduct

In your job, you may be asked to visit an operating room (OR) and assist with the setup or use of a medical device. This course addresses all aspects ...

MDR Regulation 2: Device User Facility, Importer, and Manufacturer Reporting Requirements

Medical device manufacturers, user facilities, and importers need to identify and monitor significant adverse events involving medical devices. This ...

MDR Regulation 3: Requirements for Individual Adverse Event Reports

FDA investigators, compliance officers, medical device manufacturers, user facilities and importers need to know how to document and submit adverse ...

MDR Regulation 1: Overview and General Provisions

FDA Investigators, compliance officers, medical device manufacturers, user facilities, and importers need to be aware of the Medical Device Reporting ...

EU In Vitro Diagnostic Regulations (IVDR)

This course describes information about the compliance of the in vitro diagnostic medical devices in accordance with the European In Vitro ...

EU Medical Device Regulation (MDR)

This course describes basic information concerning the European Medical Device Regulation and the CE marking of medical devices. Topics in this ...

Meeting Process Requirements for Returned and Salvaged Drug Products

Like any other product, pharmaceuticals may be returned from the marketplace for a variety of reasons, including overstock, mislabeling, or product ...

Good Laboratory Practices (GLPs)

Nonclinical laboratory studies are one of the first steps taken in bringing a new drug, device, or biologic to the marketplace, so it is important ...

Complaint Management for Pharmaceutical Manufacturers

There are specific requirements regarding how companies must receive, investigate, document, file, and report customer complaints. This course ...

Promotion of Pharmaceutical Products -- In House

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HIPAA and Privacy Guidelines for Pharmaceutical Sales Representatives

It is important for Pharmaceutical Sales Representatives to know how our sensitivity to customers’ privacy concerns is critical to maintaining their ...

Promotion of Pharmaceutical Products -- Field Facing

This course outlines the guidelines, rules, and regulations that pharmaceutical companies must follow when promoting their products to healthcare ...

Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations

This course provides an overview of Postmarketing Adverse Drug Experience (PADE) regulations, guidance, inspectional candidate selection, ...

Introduction to the Regulation of Prescription Drug and Biologic Promotions

Promotional messages for prescription drugs are different from most commercial campaigns because the drugs, and the claims pharmaceutical companies ...

Medicare Health Plan and PDP: Fraud, Waste, and Abuse

<p>Healthcare fraud, waste, and abuse are considered a top priority to the US government, second only to terrorism and violent crime. This ...

Investigational Product Development

This course provides an overview and summary of the investigational product development process. The course includes information on the different ...

Q10 Pharmaceutical Quality System

This course describes a model for an effective quality management system for the pharmaceutical industry. The course is based on guidance developed ...

ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials

ISO 14155 is intended to be applied worldwide to clinical investigations of medical devices in order to fulfill the various national, regional, and ...

Global Regulatory Strategy and Planning Process

This course discusses creating the strategy and planning documents that help companies align the development of new products with the regulatory ...

Americans with Disabilities Act

The course identifies who is classified as a disabled employee and how these employees are protected under the Americans with Disabilities Act (ADA). ...

Import Operations 2: The Process

The second in a series of three, this course addresses FDA import and export programs, procedures, and policies and introduces the process followed ...

Hazard Communication

Hazard communication protects employees by providing information about hazardous chemicals and how to handle them correctly. This course identifies ...

Laboratory Specimens for Clinical Research

This course will introduce you to regulations and guidelines that oversee the process of laboratory sample collection and shipping of human specimens ...

Drug Safety & Adverse Event Reporting

&amp;lt;!--td {border: 1px solid #ccc;}br {mso-data-placement:same-cell;}--&amp;gt;This course explains the regulatory requirements in the ...

Import Operations 1: Background

The first in a series of three courses, this course introduces FDA’s import program and the laws applied to products offered for entry into the US ...

Benzene

One of the most beneficial and most dangerous compounds in manufacturing today is benzene. This course outlines the hazards of benzene and ways to ...

The Approval Process for New Medical Devices

This course provides an overall view of the development regulatory process for legally marketing a new medical device in the US. Topics in this ...

Medicare Advantage: Provider Compliance

<p>This course reviews requirements every provider must adhere to, including specific rights and responsibilities, and elements contained in ...

Heat Stress

Exposure to extreme heat can result in occupational illnesses and injuries. This course explains what heat stress is, who is at risk of heat stress, ...

Import Operations 3: Other Activities

This course continues discussion on import operations. Topics in this course include: Filers, Sharing Information, Exports, Export Certificates, and ...

Medical Device Safety Reporting

This course explores the process by which US and European regulatory agencies ensure the safety of medical devices used in medical facilities and ...

Medicare Advantage: Grievances, Organization Determinations, and Appeals

<p>The Medicare Part C program provides coverage for medical benefits for eligible Medicare beneficiaries. This course describes the grievance, ...

Fall Protection

Falls are a leading cause of accidents on construction sites, killing hundreds and disabling hundreds of thousands of workers each year. This course ...

Recognizing and Avoiding Insider Trading

This course will identify common situations that violate insider trading laws. Topics in this course include: Recognizing Inside Information and ...

Sterile Dosage Forms Introduction

Because of the risk of infection from non-oral medications, manufacturers must ensure the sterility of sterile dosage forms. This course describes ...

Selecting and Managing Clinical Contract Research Organizations (CROs)

This course provides information on the processes commonly used to select and manage a clinical contract research organization (CRO) and other ...

Ethical Review Boards

This course addresses the role, responsibilities, and regulatory requirements of Institutional Review Boards (IRBs)/Independent Ethics Committees ...

GCP/ICH Obligations of Sponsors, Monitors, and Investigators

This course addresses the GCP obligations of sponsors, monitors, and investigators as described in the ICH GCP Guideline.

Implementing an Equipment Qualification Program

A well-developed and established equipment qualification program allows a company to meet current GMP requirements and save operational costs at the ...

Environmental Control and Monitoring

It is important for all personnel involved in the manufacturing of sterile products and medical devices to understand how to maintain the quality of ...

Orientation to GMP Compliance

Because FDA GMP regulations have a direct impact on how you do your job, you need insight on how they are applied and interpreted. This course ...

Handling a Product Recall

This course defines product recalls and explains their impact on the manufacturer, FDA’s requirements and enforcement when dealing with a product ...

GxPs

Regulated Good Practices (GxPs) apply to the development, clinical testing and manufacture of drugs, biological products and medical devices to ...

Gowning for Sterile Manufacturing

Because of the importance of preventing contamination in finished sterilized pharmaceuticals or medical devices, anyone involved in the production of ...

Writing Validation Protocols

This course is an introduction to the importance and content of the documentation that comprises validation. Topics in this course include: ...

Maintenance and Cleaning of Drug Manufacturing Equipment

Properly designed, constructed, cleaned, and maintained equipment lies at the core of the process control necessary to consistently manufacture pure, ...

Basics of Cleanroom Operations

Cleanrooms play a major role in preventing product contamination and ensure product sterility and safety. This course describes the general ...

Recruitment and Retention of Study Patients

This course will discuss recruitment and retention of volunteers within a clinical trial. Topics in this course include: Pre-recruitment, ...

Aspects of Regulatory History

Regulatory standards for conducting clinical trials are in place to protect those conducting and participating in clinical trials. This course ...

Clinical Trial Audits and Consequences of Non-Compliance

Sponsors can put measures in place in an attempt to dissuade researchers from being noncompliant, but those measures are only as effective as the ...

Overview of the Clinical Research Process

Clinical research is the testing of experimental drugs, biologics, and medical devices in humans. This course describes the clinical research process ...

HIPAA -- The Impact On Clinical Research

Congress enacted the Health Insurance Portability and Accountability Act (HIPAA) to protect patient privacy and confidentiality. This course explains ...

Obligations of Investigators in Conducting Medical Device Trials

This course addresses the requirements for conducting clinical trials for investigational premarket medical devices. It provides an overview of the ...

Business Practices to Protect Personal Health Information

This course provides all employees and associates with knowledge of the privacy and security practices for health plans, as required by the Health ...

GCP/ICH Obligations of Sponsors and Monitors

This course describes sponsor and monitor requirements and responsibilities for the conduct of clinical trials in support of new drug and biologics ...

Introduction to Data Integrity

This course provides foundational knowledge of the concepts of data integrity and quality. Topics in this course include: Regulatory Requirements, ...

European Union Clinical Trials Directive

The European Union (EU) Clinical Trials Regulation covers clinical trials in the EU and sets forth requirements of investigators, sponsors, EU Member ...

MAPD: Enrollment

<p>To ensure proper member enrollment, specific standards must be maintained. This course describes processes and procedures for enrollment for ...

Medicare Part D: Medication Therapy Management and Quality Improvement Program

<p>This course identifies primary cost control provisions in detail, including drug utilization management (UM) and medication therapy ...

MAPD: Disenrollment

To ensure proper member disenrollment, specific standards must be maintained. This course describes processes and procedures for disenrollment from ...

Medicare Advantage: Overview of the Medicare Program

This course provides an overview of the Medicare Program including what it is, how it is implemented, and how government regulations influence it. ...

General Data Protection Regulation

<p>This course covers the European Union’s (EU’s) General Data Protection Regulation (GDPR), which is a harmonized data privacy law across ...

Sexual Harassment Awareness for New York Employees and Supervisors

<p>Sexual harassment is a serious issue facing employers. This course is designed to educate you about New York and federal laws regarding ...

Writing and Reviewing SOPs

Identify the rationale and GMP requirements for written SOPs. Recognize which areas require procedures and how those procedures are developed. ...

DEA Compliance

Identify how the DEA enforces the laws and associated regulations under the CSA. Recognize how these regulations complement those of the Food, Drug, ...

Packaging and Labeling of Finished Pharmaceuticals

Recognize GMP requirements for packaging and labeling. Identify the systems and procedures that prevent mix-ups.

Isolators for Aseptic Processing

This course describes critical operating principles for the successful operation of an isolator for aseptic processing. Topics in this course ...

RABS for Aseptic Processing

<p>Restricted Access Barrier System (RABS) technology was developed to remove operators from the critical processing zones during sterile ...

Building Customer Loyalty

<p>This course teaches the skills needed by employees at all levels of a company to create loyalty, and to impact the company’s profitability ...

Recalls of FDA Regulated Products

The monitoring of recalls of potentially hazardous consumer products is one of the most important activities performed by FDA personnel. This course ...

FDA Establishment Inspection Report Writing

<p>Establishment inspection reports (EIRs) are written reports that create a record of an inspection of a regulated firm. This course ...

Courtroom Testimony

<p>This course will introduce you to your role if you are called as an FDA witness, including grand jury, deposition, declaration, and ...

The Role of the Clinical Research Associate

This course explores the role of the clinical research associate (CRA) in monitoring a clinical trial and acting as a liaison between the ...

Administrative Roles of the Clinical Research Associate

This course examines the administrative roles and responsibilities of the Clinical Research Associate (CRA) during specific on-site monitor visits ...

HIPAA Privacy: Role-Based Training II (Internal Uses of PHI)

<p>This course is designed for employees who are authorized to use protected health information (PHI) as part of their regular duties. Topics ...

Medicare Advantage: Plan Benefit Package and Bid Pricing Tool

This course covers benefits, plan benefit packages (PBPs), and tools for submitting bids. Topics in this course include: Benefits, PBP Design, PBP ...

Medicare Plan: Broker and Agent Training - Medicare Basics

<p>This is course two in the required series of courses that must be taken by brokers and agents who are interested in marketing Medicare ...

Medicare Plan: Broker and Agent Training - Medicare Part C and Part D Enrollment & Disenrollment

<p>This is course three in the required series of courses that must be taken by brokers and agents who are interested in marketing Medicare ...

OIG Compliance Program Guidance for Medical Device Manufacturers -- Field Force

This course identifies practices that present a potential risk of liability for medical device manufacturers under the three major risk areas ...

Medicare Part D: PDP Enrollment

<p>The Medicare Part D program provides prescription drug coverage for eligible Medicare beneficiaries. This course describes processes and ...

Medicare Part D: PDP Disenrollment and Transaction Processing

<p>The Medicare Part D program provides prescription drug coverage for eligible Medicare beneficiaries. This course describes processes and ...

Principles of Restricted Access Barrier Systems and Isolators

This course introduces the basic principles of two specific types of improved aseptic processing: Restricted Access Barrier Systems (RABSs) and ...

Evidence and Proof

FDA takes action based on information collected and developed by investigational and analytical personnel. FDA’s ability to perform its function is ...

Special Investigations

This course will provide an overview of the broad spectrum of investigations performed by the Food and Drug Administration (FDA). Topics in this ...

Field Examinations

Field examinations help to ensure the safety, purity, and compliance of products released for public use. For imported products, field exams help to ...

Hiring and Firing

Hiring is an important factor in creating a solid workforce, and firing is a tool to ensure productivity. This course provides techniques for making ...

Dos and Don’ts of Aseptic Environments

This course introduces best practices for aseptic technique and behavior for use with conventional cleanroom aseptic processing. Topics in this ...

Accurate Company Records

Companies have a legal obligation to create and retain records that accurately reflect their business transactions. Fraudulent reporting of books, ...

FDA Good Guidance Practices (GGPs)

This course on FDA Good Guidance Practices (GGPs) explains which Agency documents are considered guidance documents. It also explains why we have ...

Overview of the Preparation Requirements for the ICH Common Technical Document

This course is an overview of how completed research studies are organized and summarized to be in compliance with the International Conference on ...

HIPAA Privacy: Role-Based Training I (Incidental PHI Contact)

<p>This course is designed for employees who do not access PHI as part of their regular duties, but need to know what they should do when they ...

Medicare Plan: Broker and Agent Training - Broker/Agent Requirements

<p>This course is the first of a series covering brokers and agents marketing and selling Medicare Part C and Part D products and Section ...

Medicare Part D: Grievances, Coverage Determinations & Appeals

<p>This course outlines the Centers for Medicare &amp; Medicaid Services’ (CMS’) requirements for the grievances, coverage determinations, ...