Electrical Safety

Identify the basic principles of electricity. Recognize how to identify and control electrical hazards. Recognize how to minimize the risks of injury ...

Bloodborne Pathogens -- General Industry

Identify the risks of working around bloodborne pathogens, the controls in place to eliminate or reduce those risks, and the equipment that can help ...

Bloodborne Pathogens -- Healthcare Workers

Recognize the definition of bloodborne pathogens and identify some of the diseases they can cause. Recognize controls and procedures that can lower ...

Driver Safety Program (DSP)

Identify how to drive defensively, what can stop you from driving safely, and what to do when you run into problems while driving.

Fire Safety for Healthcare Workers

Recognize the sources of heat, oxygen, and fuel that can start a fire. Recognize regulatory considerations for healthcare facilities regarding fire ...

Postmarket Reporting of Adverse Drug Experiences

Identify the process for reporting postmarketing adverse drug experiences to FDA.

Documenting the Drug Development Process ICH Q8(R2)

Recognize the guidance from FDA covering the documentation of pharmaceutical drug development. Identify how the guidance can be used to consistently ...

Medicare Part D: Bid and Benefit Package

Recognize the benefits offered under both standard and alternative prescription drug coverage. Identify the requirements for successful bidding. ...

Hot Work Permits

Identify the process of hot work area evaluation. Recognize the contents of a hot work permit. Recognize the responsibilities of management, workers, ...

Q9: Quality Risk Management

Identify the methodology and tools used in a risk management process. Recognize the operational areas where risk tools can be used to increase ...

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

Identify the steps leading to the final FDA review and approval for marketing of a new product.

FDA Establishment Inspection (EI)

Identify the statutory authority for establishment inspections. Recognize the procedures to prepare for, conduct, and conclude inspections.

Introduction to Medical Device Health Care Compliance

Recognize the various laws, regulations, and guidance that regulate the medical device industry. Identify the agencies that enforce medical device ...

Combustible and Flammable Liquids

Identify guidelines and precautions for handling, transporting, and storing combustible and flammable hazards found in your workplace. Recognize ...

Computer Workstation Safety

Identify common RSIs, their symptoms, their causes, and exercises and other safety measures that can help you prevent them.

Ergonomics: Body Mechanics and Fitness

Identify the different parts of your back and ways to protect them from injury. Recognize body mechanics and ergonomics in the workplace. Recognize ...

Guidelines of Workplace Safety

Recognize potential workplace accidents and hazards. Recognize the roles of the employer and employee in maintaining workplace safety.

Managing Conflict

Recognize the five different styles used to handle conflict. Identify how to approach and resolve conflict successfully in the workplace.

Active Listening Skills

Recognize how to improve your active listening skills and gain an understanding of the significance of listening. Identify the seven listening ...

Privacy and Data Protection

Recognize what personal information must be protected according to the law and our company policies, as well as your personal responsibility in ...

Foreign Corrupt Practices Act (FCPA)

Recognize and prevent certain potential FCPA violations.

Making Ethical Decisions

Recognize how to identify and resolve ethics issues and concerns. Identify how to get help when you are unsure of the best course of action.

Doing the Right Thing: Anti-bribery

Identify and navigate situations that may be perceived as bribery. Recognize requirements of the U.S. Foreign Corrupt Practices Act (FCPA). Identify ...

Handling Confidential Information

Identify confidential information and take the necessary steps to safeguard information in your workplace. Recognize your responsibilities for ...

Recognizing and Avoiding Conflicts of Interest

Recognize the circumstances that can cause actual or potential conflicts of interest. Recognize the steps to take to avoid these conflicts or to ...

Safeguarding Intellectual Property

Identify the definition of intellectual property. Identify the four basic types of IP that our company is involved with. Recognize the legal and ...

Detecting and Preventing Fraud

Identify the warning signs of fraud and recognize these signs in your workplace. Recognize when fraud is being committed and how to report suspected ...

E-Mail and Corporate Communications

Recognize what happens when e-mails are sent and received. Identify e-mail privacy and security issues and the dangers of viruses.

Doing the Right Thing for Customers and Business Partners

Recognize how to build strong relationships with our customers and business partners. Identify our company’s expectations for our relationships with ...

Medicare Advantage: Administration and Management

Recognize the critical role of management in operating an MAO. Identify the basic administrative infrastructure necessary to do business with CMS in ...

Medicare Advantage: Membership Services

Identify the functions of Member Services in a Medicare Advantage Organization. Recognize CMS regulatory requirements related to Member Services. ...

Quality Systems Approach

Identify FDA’s guidance on modern quality systems and recognize how this can foster GMP compliance, innovation, and continuous improvement in the ...

Hazardous Waste Disposal

Recognize the regulatory approach in the US for handling hazardous waste. Identify the EPA forms used for the tracking process.

HAZWOPER Awareness

Recognize what hazardous materials are and be able to identify the members of the Hazardous Material (HAZMAT) team. Recognize the difference between ...

Medicare Advantage: Claims Processing

Differentiate between contracted and non-contracted providers and how claims should be processed using the reimbursement methodologies as set forth ...

Medicare Advantage: Provider Networks

Recognize tools that may be used to develop and validate provider networks. Recognize the usefulness of “model” contract provisions and checklists. ...

Medicare Advantage: Quality Management and Utilization Management

Identify the basics of QI program implementation. Identify the standards of a QI program. Recognize the processes and requirements for conducting ...

MAPD/PDP: Marketing

Identify the marketing materials that are regulated by CMS, the information that must be included in the materials, and how the CMS approval process ...

MAO/PDP: Compliance Program Guidelines

Recognize the requirements for implementation of an effective compliance program.

Special Needs Plans: Model of Care

Identify the required elements of a Special Needs Plan’s Model of Care as well as the scoring criteria that are used as part of the review and ...

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

Recognize CMS’ process for coordinating prescription drug benefits among payers. Recognize the requirement for calculating and maintaining accurate ...

Emergency Preparation, Recognition, Control, Communication, and Response

Identify what constitutes an emergency. Recognize what to report if you are the first person to become aware of an emergency. Identify the roles of ...

Emergency Response: Hazardous Spill

Recognize the organization and staff of the Incident Command System (ICS). Identify the confinement, containment, and control responsibilities of the ...

Incident Command System: Structure and Components

Identify the five major management functions of the ICS and recognize each management function of the ICS. Identify the basic chain of command of the ...

Incident Command System: Responsibilities

Identify the responsibilities of the General and Command Staff members. Identify the responsibilities of ICS personnel during an emergency situation. ...

Safety Hazards and Equipment

Identify safety hazards that are commonly present in the pipeline industry. Recognize the purpose and general operation of a combustible gas and ...

Spill Prevention and Response Procedures

Recognize what a spill is and how to report it. Recognize the correct procedures to use when responding to a spill by referencing the Spill ...

Drugs and Alcohol: Agencies and Laws

Recognize the agencies and laws that form the framework for employer policies on alcohol and drug testing. Identify how that framework affects your ...

Drugs and Alcohol: General Information

Recognize the effects and consequences of alcohol and drug use while on the job in a DOT covered function.

Drugs and Alcohol: General Testing Information

Identify the individuals in DOT-regulated positions who may be tested for drugs or alcohol. Recognize the specific circumstances under which these ...

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

Identify the testing environment, sample collection procedures, and laboratory procedures that ensure consistent and accurate results from drug and ...

QSIT 1 -- Beginning the Inspection

Recognize the origin and scope of QSIT. Recognize the basic concepts associated with how to sample records for review during an inspection conducted ...

QSIT 2 -- The Management Controls Subsystem

Identify the seven Inspectional Objectives associated with the Management Controls subsystem and recognize some of the ways to accomplish those ...

QSIT 3 -- The Design Controls Subsystem

Identify the fifteen Inspectional Objectives associated with the Design Controls subsystem. Identify some of the ways to accomplish those objectives.

QSIT 4 -- The Corrective and Preventive Actions Subsystem

Identify the ten inspectional objectives associated with the CAPA subsystem and recognize the ways to accomplish those inspectional objectives.

QSIT 5 -- The Production and Process Controls Subsystem

Recognize the six inspectional objectives of the Production and Process Controls subsystem and techniques for accomplishing those objectives.

Systems Based Drug Inspections

Recognize the guidance provided by FDA for investigators inspecting drug firms for GMP compliance. Recognize the guidance provided in CP 7356.002 ...

ICH Q7A: Introduction and Quality Management

Recognize the purpose of the Q7 Guideline and how it fits in with current regulatory expectations and practices in the United States — especially in ...

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

Recognize FDA expectations for compliance with all applicable predicate rules. Identify how the Agency plans to interpret and enforce Part 11 with ...

Part 11: Electronic Records and Signatures -- Application

Recognize how to apply Part 11 regulations to your company’s systems and records in accordance with FDA’s expectations. Identify what records are ...

Part 11: Electronic Records; Electronic Signatures

Identify the regulatory requirements for electronic records and electronic signatures. Recognize FDA expectations for compliance.

Computerized Systems Inspections in the Medical Device Industry

Recognize where computerized systems are used in the medical device manufacturing process. Recognize FDA’s approach to inspecting computerized ...

Auditing of Computer System Validation to Ensure Data Integrity

Recognize the requirements for data integrity, validation activities, and documentation. Recognize an approach to inspecting computerized systems ...

Preventing Sexual Harassment

Identify appropriate and inappropriate behavior as defined by the law and company policy. Recognize how to respond effectively when faced with ...

Discrimination and Harassment Free Workplace

Recognize how diversity is important to our success. Identify the laws and policies that define discrimination and harassment. Recognize acceptable ...

Physical and Network Security

Recognize security risks to our company’s physical and virtual assets. Identify your responsibilities for protecting all of these resources. ...

Age Discrimination

Identify the provisions of the ADEA. Recognize a fair and equitable working environment for employees.

Affirmative Action in the Workplace (For Employers)

Recognize when affirmative action requirements for federal contractors are triggered and understand the structure of Affirmative Action Plans (AAPs). ...

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

Recognize the significant aspects of the legislation. Recognize the important exemptions specified by the legislation that affect employers and many ...

ICH Q7: Resources and Materials Management

Identify the general requirements for qualification of API manufacturing personnel. Identify the requirements for buildings and facilities as well ...

Change Control

Identify what a change control consists of and recognize the basics of the change control model. Recognize the importance of a change control. ...

Introduction to GMPs

Recognize cGMPs and their importance to the pharmaceutical and medical device manufacturing industry. Identify basic cGMP requirements and the roles ...

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

Identify the cGMP requirements for the receipt, identification, handling, storage, sampling, and testing of components, labeling, containers, and ...

Writing and Reviewing SOPs

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

Understanding Post-Approval Changes

Recognize PAC guidance and how these documents are used to provide notification to FDA for post-approval changes to an approved drug application. ...

Resolving Out Of Specification Test Results

Recognize the possible causes of OOS results. Identify the requirements for handling an investigation of OOS results. Identify how to work with ...

Conducting Annual Product Reviews

Recognize the benefits of conducting an APR. Recognize how to organize an APR. Identify the contents of an APR.

Batch Record Reviews

Recognize the definition of batch records and the purpose of reviews. Recognize the key elements and reasons for organized batch records. Identify ...

GMP Principles of SOPs

Identify what SOPs are, what their purpose is, and how they are structured. Recognize how to handle changes to SOPs as well as how SOPs are used in ...

Awareness of FDA Inspections for Pharmaceutical Manufacturers

Identify the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and the areas/operations typically ...

FDA Training and Qualification Requirements

Identify FDA requirements for personnel training and qualification, responsibilities of personnel, and how to measure training and qualification.

Corrective and Preventive Actions

Recognize applicable regulatory requirements and other important aspects of implementing an effective corrective and preventive actions (CAPA) ...

Pre- and Post-Approval FDA Drug Inspections

Recognize what constitutes a pre- or post-approval inspection. Recognize what possible outcomes may result. Identify some helpful recommendations for ...

Failure Investigations for Pharmaceutical Manufacturers

Identify the failure investigation process. Recognize how GMP regulations address failure investigations and the key components of a good ...

GMP Principles for Batch Records

Identify regulatory requirements and responsibilities for completing batch records. Recognize documentation elements that are required in ...

Handling an FDA Inspection

Recognize the elements of an FDA inspection and your role during the inspection. Identify how an inspection is conducted and how to conduct yourself ...

Essentials of an Effective Calibration Program

Identify the essentials of an effective calibration program. Identify what calibration standards are and the regulatory requirements needed for ...

Meeting GMP Training Requirements

Identify cGMP training requirements as well as other important cGMP training issues, such as types of training, approaches to training, trainer ...

Effectively Responding to FDA 483s and Warning Letters

Recognize the basic principles of FDA 483s and the use of Warning Letters. Recognize the significance of both these documents. Identify the key ...

Vendor Certification for Pharmaceutical Manufacturers

Identify regulator concerns about supply chain quality Recognize new regulations and guidances coming into effect. Identify critical supplier quality ...

GMP Updates: Supply Chain Quality and Emerging Compliance Concerns

Recognize the critical concerns of supply chain quality in the medical device and pharmaceutical industries. Identify the challenges manufacturers ...

Combination Products – cGMP Requirements

Identify the four different types of combination products. Recognize the scope of the new regulation in 21 CFR Part 4, and each of the drug, device, ...

Management Responsibility for Quality: What FDA Expects

Identify management’s specific responsibilities in developing and maintaining a Quality System.

Role of the Qualified Person

Identify the role and responsibilities of both types of QP. Recognize how these fit within EU legislation.

European Union Good Distribution Practices for Medicinal Products

Identify the EU requirements for maintaining product quality and integrity at each stage in the distribution process as defined in Directive ...

European Union GMP Requirements

Identify the EU’s basic GMP regulations and recognise how you comply with these requirements.

Validation of Analytical Laboratory Procedures

Identify applicable regulatory requirements. Recognize the important aspects of analytical methods validation, including the data that must be ...

Data Integrity for Quality Control Laboratories

Recognize the history of data integrity. Identify the types of data integrity issues found by FDA. Recognize possible consequences of data integrity ...

Good Documentation Practices for Medical Device Manufacturers

Recognize the critical importance of creating and maintaining good documents. Identify the stages of the Documentation Life Cycle. Recognize ...

FDA 483s: Inspectional Observations

Recognize the purpose of issuing an FDA 483. Identify what kinds of inspectional observations are included on an FDA 483, when it is issued to the ...

Risk Management in Pharmaceutical Manufacturing

Recognize FDA’s guidance on risk management and the potential uses and benefits for our industry as a whole.

Pharmaceutical Risk Management: Picking the Right CAPA Tools

Recognize the tools available that can help achieve an effective corrective and preventive actions (CAPA) process.

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, ...

How to Meet Drug Retention and Stability Testing Requirements

Recognize the importance of maintaining drug safety and effectiveness over a product’s shelf life. Recognize basic Principles of Stability and the ...

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

Recognize the difference between ISO 13485 and ISO 9001. Recognize the process approach of ISO 13485. Identify management’s role in implementation ...

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

Recognize the specific requirements of ISO 13485.

Principles of Good Documentation

Recognize the importance of good documentation practices. Identify common forms of documentation used during the manufacturing process and the ...

Diversity in the Workplace

Recognize the changing work environment. Identify how to improve their working relationships with people from different backgrounds.

Family and Medical Leave Act (FMLA)

Recognize the provisions of FMLA. Identify how the Act protects employees in certain situations.

Sexual Harassment Awareness for Employees

Recognize that harassment is a personal issue and that your definition of offensive behavior may differ from that of your coworkers. Identify ...

Sexual Harassment Awareness for Managers

Recognize how to prevent and respond to sexual harassment in a responsible manner.

Substance Abuse

Recognize the signs and symptoms of drug and alcohol abuse. Identify the steps you can take to deal with a substance abuse problem.

Violence in the Workplace

Recognize individuals prone to violent behavior. Identify proven techniques to diffuse dangerous situations.

Confidentiality, Intellectual Property Protection, and Information Security

Recognize what information is considered sensitive and recognize if you are dealing with it. Identify the ways you can protect sensitive information ...

Harassment in the Workplace

Recognize behaviors that are typically considered workplace harassment. Identify ways to avoid harassing behavior and what to do if you are harassed. ...

Harassment Avoidance Training for California

Identify company policies that prohibit sexual harassment. Recognize what constitutes harassment and how to apply the laws and company policies to ...

Safe Driving

Identify the principles of safe driving. Recognize the numerous steps of a pre-trip inspection, as well as the steps to safely securing the ...

Preventing Back Injuries

Recognize proper postures for common activities such as sitting, lying, and standing. Recognize stretching and strengthening exercises that can aid ...

Laboratory Safety

Identify the types of hazards that make a laboratory unsafe. Identify how to prevent or eliminate these hazards through compliance with safety ...

Access to Employee Exposure and Medical Records

Identify what information can be found in medical and exposure records. Recognize where these records are located. Identify who is responsible for ...

Office Safety

Recognize safe work practices that will help you identify and remove hazards that can lead to accidents. Recognize how to interpret and follow ...

PPE Assessment

Recognize how to perform a workplace hazard assessment for PPE. Identify what hazards to look for. Recognize how to collect and organize assessment ...

Process Safety Management: Overview

Recognize what Process Safety Management (PSM) is and who it covers. Recognize the components of PSM. Identify the importance of employee ...

Safety Signs and Color Codes

Recognize safety signs, color codes, and tags that are used to identify hazards in the workplace. Identify directional signage and the signage ...

Scaffold Safety

Identify safe scaffolding procedures. Identify and prevent scaffold hazards from occurring.

Walking and Working Surfaces — Affected Person

Recognize hazards common to walking and working surfaces. Identify how to prevent hazards to walking and working surfaces.

National Patient Safety Goals

Identify standardized credentialing training for HCIRs. Recognize the five substantive training areas recommended for HCIRs. Identify how this ...

Basics of PhRMA Code

Recognize how the PhRMA Code impacts your interactions with healthcare professionals.

Medical Education for Healthcare Professionals

Identify the various types of consulting arrangements that exist between a pharmaceutical company and healthcare professionals and the guidelines ...

Antitrust Law and Competitor Relationships

Recognize the antitrust laws that govern competitor interactions as well as their application to everyday business situations.

Code of Business Conduct

Identify the basic principles of our Code of Business Conduct and recognize how to apply those principles to your everyday business activities.

Basics of the AdvaMed Code

Recognize how the AdvaMed Code guides your interactions with HCPs.

Reporting Adverse Events for Medical Devices

Identify what a medical device report is and the types of reports that exist. Recognize a company’s requirements for reporting adverse events for ...

Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation (MA Regulation)

Recognize the provisions of the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation (MA Regulation), 105 CMR 970.000. ...

MedTech Europe Code of Ethical Business Practice

Recognize the guidelines that apply to the many types of interactions between MedTech Members and HCPs and HCOs. Recognize the importance of ...

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

Identify the essential elements of the 510(k), premarket approval (PMA), and Investigational Device Exemption (IDE) filing processes for medical ...

Sarbanes-Oxley Act: An Overview

Identify the purpose and main provisions of the Sarbanes-Oxley Act. Identify corporate responsibilities that Sarbanes-Oxley mandates.

Global Anti-Bribery

Identify the two main provisions of the Foreign Corrupt Practices Act (FCPA) and common components of many anti-bribery laws around the world. ...

Global Fair Competition Laws

Recognize the types of agreements that have the potential to restrict competition. Identify the fair competition laws that govern and often prohibit ...

Introduction to Pharmaceutical Compliance

Recognize the various agencies that govern standards of behavior in the pharmaceutical industry as well as the key requirements for compliant ...

Interactions with Healthcare Professionals - In-House

Identify the guidelines, policies, rules, and regulations that govern interactions with healthcare professionals. Identify the appropriate manner in ...

Interactions with Healthcare Professionals - Field

Identify the guidelines, policies, rules, and regulations that govern interactions with healthcare professionals. Recognize the appropriate manner ...

Regulatory Requirements for Medical Devices in the Republic of Korea

Identify the regulations that apply to the marketing of medical devices in Korea. Recognize upcoming changes to those regulations as well as aspects ...

Principles of Cleaning Validation

Identify the basic elements of cleaning validation. Recognize how cleaning procedures are developed, why a cleaning Standard Operating Procedure ...

Understanding the Principles and Practices of Process Controls

Recognize what process control is. Identify the written procedures involved in validation Identify the ways that equipment affects process controls, ...

Collecting Samples and Establishing Limits for Cleaning Validation

Identify advantages and disadvantages of commonly used sampling methods. Recognize the need for established limits of cleanliness in cleaning ...

Documenting Validation Activities

Recognize FDA’s definition of validation. Identify the requirements for cGMP compliant documentation of validation processes.

Physician Payment Sunshine Act

Recognize the meaning and purpose of the Physician Payment Sunshine Act. Recognize the definition of key terms and phrases, such as, “applicable ...

HIPAA and Privacy Guidelines for Medical Device Sales Representatives

Recognize the basic provisions of the HIPAA Privacy Rule. Recognize how HIPAA affects our detailing and customer support activities. Identify how to ...

Principles of Sterilization

Recognize the definition of sterilization and identify the most common sterilization methods. Recognize the general approaches for validating and ...

Principles of Aseptic Processing

Recognize the general principles and practices necessary to ensure product sterility and safety. Identify the Good Manufacturing Practices (GMP) ...

A Step-by-Step Approach to Process Validation

Recognize the definition of process validation as it relates to pharmaceutical products and medical devices. Identify the steps involved in process ...

Key Concepts of Process Validation

Identify applicable regulatory requirements. Recognize important aspects of process validation. Identify the components of the validation life ...

Understanding GMPs for Facilities and Equipment

Recognize the importance of Good Manufacturing Practices. Identify the requirements that specifically apply to facilities and equipment.

Data Integrity: The Role of Quality Assurance for Data Integrity

Recognize the definition and importance of a process approach to quality, and recognize activities that help maintain quality of data. Identify ...

Data Integrity for Clinical Research Staff

Identify the role of clinical staff in data integrity. Recognize the importance of data integrity and various challenges to data integrity. ...

Review of Basic Statistical Techniques

Recognize how to interpret data using basic statistical techniques. Recognize how to solve technical problems in a straightforward manner and comply ...

Risk Management 1: Key Concepts and Definitions

Recognize the definitions of risk and related terms. Identify the ways risk can be expressed. Differentiate between safety and risk. Identify the ...

Requirements for Computerized Systems Validation and Compliance

Recognize the regulatory requirements for the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, ...

Approach to Computerized Systems Validation and Compliance

Identify the type of framework that is suitable for computerized systems validation and compliance. Recognize planning and reporting requirements. ...

Computerized Systems Inspections in the Pharmaceutical Industry

Recognize where computerized systems are used in the pharmaceutical manufacturing process. Recognize FDA’s approach to inspecting computerized ...

A Tour of FDA

Recognize FDA’s public health mission and how the Agency is organized to carry out its mission. Recognize the history of FDA and the products that ...

Biotechnology: An Overview of Compliance Considerations

Recognize what a biotechnology-derived product is. Identify why and how the Food and Drug Administration (FDA) regulates them. Identify the key ...

Application of GMPs to Analytical Laboratories

Identify cGMP requirements as they apply to analytical laboratory practices. Recognize key concepts related to laboratory documents, raw data, and ...

The Design and Development of Software Used in Automated Process Controls

Identify the SDLC under regulatory requirements for the design, development, and control of software used in automated process controls. Recognize ...

Application of GMPs to Microbiology Laboratories

Identify the importance of handling raw data. Recognize the key approaches for ensuring accurate results. Recognize how to monitor, validate, and ...

Packaging and Labeling of Finished Pharmaceuticals

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

ISO 14971: Risk Management for Medical Devices

Recognize Risk Management’s role towards medical devices product safety. Idenitfy the elements of the risk management process. Recognize the purpose ...

MAPD: Risk Adjustment and Data Validation

Identify the principles and motivation for risk adjustment. Identify the components of the risk adjustment process. Recognize the requirements for ...

ICH GCP Obligations of Investigators Conducting Clinical Trials

Recognize how to comply with GCP guidelines. Identify principal obligations with respect to qualifications and agreements, Institutional Review ...

Information Security

Recognize the security policies, procedures, and controls that are part of our daily business routine. Identify suspected security breaches and how ...

Deficit Reduction Act: False Claims and Employee Protections Training

Recognize what the federal False Claims Act is and how it pertains to fraud and abuse in Medicaid programs. Identify the provisions for protection ...

HP: Compliance Program General Session

Identify the reasons for implementing a Compliance Program. Identify the seven essential elements that make up an effective Compliance Program. ...

Fraud and Abuse Awareness

Identify the most common types of fraud and abuse. Recognize the negative effects that fraud and abuse have on the healthcare business and its ...

Code of Conduct

Recognize the standards of conduct outlined in the Code. Identify how these principles apply to the types of activities you must perform on a daily ...

Introduction to Specialty Pharmacy Management

Identify the major types of specialty pharmacy drugs and how they are administered to patients. Recognize the costs of specialty pharmacy therapies ...

HIPAA: General Awareness

Identify the goals of HIPAA and its Administrative Simplification provisions. Identify the entities that are covered under the law and recognize how ...

HIPAA: Privacy Standards

Recognize the rules governing the use and disclosure of protected health information (PHI). Identify when an individual’s permission is required ...

Ethics as the Foundation to Clinical Research

Identify the ethical components of the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, the International Conference on Harmonisation ...

Informed Consent

Identify key historical events that led to the current informed consent regulations and guidelines. Recognize the informed consent process as well ...

The Role of the Clinical Research Coordinator

Identify the CRC’s key roles in research and patient protection from pre-study visits through study completion.

Financial Disclosure by Clinical Investigators

Recognize the types of financial arrangements that must be disclosed and the requirements for proper financial disclosure for covered clinical ...

Administrative Roles of the Clinical Research Coordinator

Identify the role of a CRC throughout a clinical trial, as well as recognize applicable Good Clinical Practice standards.

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

Identify the requirements for dietary supplement product packaging, labeling, holding, and distribution.

Dietary Supplements -- Introduction to Part 111 cGMPs

Recognize the origin and scope of cGMPs for dietary supplements. Identify the purpose of general provisions and personnel subparts as well as the 16 ...

Dietary Supplements -- cGMPS for Manufacturing Plants and Equipment

Identify FDA requirements for manufacturing plants and facilities that produce dietary supplements Identify FDA requirements for sanitation, ...

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

Identify the cGMP process control requirements for manufacturing operations, including sanitation, contamination, rejected products, specifications, ...

Dietary Supplements -- cGMP Requirements for Quality Control

Identify regulatory requirements for Quality Control operations, including material reviews and dispositions. Recognize regulatory requirements for ...

Dietary Supplements -- Requirements for Records and Recordkeeping

Recognize the importance of the Master Manufacturing Record (MMR) and Batch Production Records. Recognize effective documentation practices. ...

Design Control Regulations for Medical Device Manufacturers

Recognize the purpose and scope of design control regulations. Identify the eight main aspects of design control and how they affect medical device ...

Medical Device Packaging, Labeling, and Distribution

Recognize the requirements for the packaging, labeling, and distribution of medical devices.

Quality Systems Inspection Technique (QSIT)

Recognize how to properly prepare for a Quality Systems inspection.

Introduction to the Quality System Regulation (QSR)

"Recognize the application of GMPs to the manufacture of medical devices. Identify the components of a quality system. Recognize the elements of ...

Failure Investigations for Medical Device Manufacturers

Recognize the basic definition of failures. Identify when a failure investigation should occur and the documentation required. Identify the basic ...

Complaint Management for Medical Device Manufacturers

Identify the primary elements in an effective complaint handling system. Recognize how to document complaint information as required by FDA ...

Good Clinical Practices (GCPs) for New Product Investigations

Recognize the basic concepts and key elements of GCP, including documentation, purpose, subject protection, and regulatory authority requirements.

Protection of Human Subjects in Clinical Trials

Identify the measures that are in place to protect the rights and welfare of subjects in clinical studies. Recognize informed consent requirements ...

High Purity Water Systems

Identify the typical uses of water in pharmaceutical and medical device manufacturing. Recognize the general process for producing high quality ...

QS Regulation 1: Overview and General Provisions

Recognize the origin and scope of the QS Regulation. Identify the purpose of the Preamble and general requirements of a quality system. Recognize key ...

QS Regulation 2: Quality System Requirements

Recognize the QS Regulation requirements associated with a firm’s management responsibility, quality auditing, and personnel.

QS Regulation 3: Design Controls

Recognize the design control requirements of the QS Regulation Recognize the terms associated with design controls. Recognize requirements for ...

QS Regulation 4: Document and Purchasing Controls

Recognize the document and purchasing controls requirements of the QS Regulation. Recognize document and purchasing control procedures that ...

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

Recognize a manufacturer’s responsibilities relative to the Identification and Traceability, and Production and Process Controls requirements of the ...

QS Regulation 6: Acceptance Activities; Nonconforming Product

Recognize a manufacturer’s responsibilities relative to the Receiving, In-Process, and Finished Device Acceptance. Identify the Acceptance Status ...

QS Regulation 7: Corrective and Preventive Action

Identify a manufacturer’s responsibilities relative to the corrective and preventive action requirements of the QS Regulation.

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

Recognize a manufacturer’s responsibilities relative to the labeling, packaging control, handling, storage, distribution, and installation ...

QS Regulation 9: Records

Identify a manufacturer’s responsibilities relative to the records requirements of the QS Regulation.

QS Regulation 10: Servicing; Statistical Techniques

Recognize a manufacturer’s responsibilities relative to the servicing and statistical techniques requirements of the QS Regulation.

QS Regulation 11: Application and Inspection of QS Regulation Requirements

Recognize the application and interrelationship of QS Regulation requirements within a medical device manufacturer’s quality system. Identify the ...

Principles of Auditing

Identify the definition of an audit and the benefits audits provide. Recognize how to develop an audit team and what the team should address during ...

Operating Room Conduct

Recognize elements of the hospital environment and the OR itself. Recognize proper behavior prior to and upon arrival at the hospital. Recognize ...

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

Recognize important terms crucial to the device user facility requirements of the MDR regulation. Identify the MDR requirements as they relate to ...

MDR Regulation 3: Requirements for Individual Adverse Event Reports

Identify how user facilities, importers, and manufacturers report adverse events. Recognize the proper forms to use to report adverse events, as ...

MDR Regulation 1: Overview and General Provisions

Identify the key characteristics of the MDR regulation and its preamble as well as the key terms used in the MDR regulation. Recognize to whom the ...

EU In Vitro Diagnostic Regulations (IVDR)

Recognize essential requirements and harmonized standards for in vitro diagnostic medical devices. Identify significant legislative changes made to ...

EU Medical Device Regulation (MDR)

Identify the basic components of the EU Medical Device Regulation. Recognize the definitions and classifications that describe the devices that fall ...

Meeting Process Requirements for Returned and Salvaged Drug Products

Recognize the procedures for correct handling of returned and salvaged pharmaceutical products. Identify the regulations governing the procedures ...

Good Laboratory Practices (GLPs)

Recognize the general characteristics of GLPs. Recognize how GLPs apply to nonclinical studies

Complaint Management for Pharmaceutical Manufacturers

Identify the primary elements in an effective pharmaceutical complaint handling system. Recognize how to document complaint information as required ...

Promotion of Pharmaceutical Products -- In House

Identify the guidelines, rules, and regulations that govern the promotion of prescription drugs. Recognize how these guidelines, rules, and ...

HIPAA and Privacy Guidelines for Pharmaceutical Sales Representatives

Recognize the basic provisions of the HIPAA Privacy Rule. Recognize how HIPAA affects our detailing and customer support activities. Identify how to ...

Promotion of Pharmaceutical Products -- Field Facing

Identify the guidelines, rules, and regulations that govern the promotion of prescription drugs. Recognize how these guidelines, rules, and ...

Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations

Identify the role of the Postmarketing Adverse Drug Experience Reporting Compliance Program in monitoring and enforcing the drug safety reporting ...

Introduction to the Regulation of Prescription Drug and Biologic Promotions

Recognize how FDA defines promotional materials for prescription drugs and biologics. Recognize the organizations responsible for reviewing those ...

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

Identify fraud, waste, and abuse risk areas and related laws, regulations, and guidelines that apply to Medicare managed care. Recognize how to ...

Investigational Product Development

Recognize drug development phases as well as the main purpose of each phase. Recognize how each phase of new product development contributes ...

Q10 Pharmaceutical Quality System

Identify the approach to take in ensuring the pharmaceutical Quality System has the important principles needed to meet regulatory guidance.

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

Identify the specific requirements of ISO 14155. Recognize the roles and responsibilities of sponsors and monitors in clinical investigations of ...

Global Regulatory Strategy and Planning Process

Identify the elements of a regulatory strategy and plan that can meet your company’s development needs while meeting regulatory submission ...

Americans with Disabilities Act

Recognize who is classified as a disabled employee and how the ADA protects these individuals. Recognize how to comply with the ADA reasonable ...

Import Operations 2: The Process

Identify pre-entry activities, types of entries, and evaluation of entries. Recognize types of import resources, examinations of products and ...

Hazard Communication

Identify hazardous chemical documentation and labeling. Recognize definitions used within HazCom. Identify best practices to use in the workplace ...

Laboratory Specimens for Clinical Research

Identify the rules and regulations that apply to laboratory samples. Recognize how a sponsor utilizes the services of a central laboratory and how a ...

Drug Safety & Adverse Event Reporting

Recognize key historical events that led to the current system of drug safety monitoring, identify the role of pre-clinical testing required as part ...

Import Operations 1: Background

Recognize how FDA ensures that imported products meet US public Health standards. Recognize differences between the regulation of domestic and ...

Benzene

Identify the risks of working with benzene. Recognize methods for monitoring benzene exposure. Recognize practices to prevent fires and spills in the ...

The Approval Process for New Medical Devices

Identify the major steps in new device development. Identify the required regulatory process for the US market. Identify the purpose and ...

Medicare Advantage: Provider Compliance

Identify the responsibilities of providers who contract with Medicare Advantage Organizations (MAOs) to deliver healthcare services to Medicare ...

Heat Stress

Recognize the definition of heat stress. Recognize what causes heat stress. Recognize the health hazards associated with heat stress. Recognize how ...

Import Operations 3: Other Activities

Recognize how import filers participate in OASIS. Recognize how FDA identifies and removes violative imports from the US market. Identify how FDA ...

Medical Device Safety Reporting

Identify the regulatory requirements in the medical device clinical trial and postmarketing environments. Recognize device safety monitoring and ...

Medicare Advantage: Grievances, Organization Determinations, and Appeals

Identify the definitions for grievances, organization determinations, and appeals. Recognize the Medicare health plan’s responsibilities in the ...

Fall Protection

Recognize the dangers of all falls. Recognize the greater dangers of falls from height. Recognize fall protection requirements that apply to any ...

Sterile Dosage Forms Introduction

Identify the requirements of sterile products. Identify the methods of aseptic production. Identify the cleanroom requirements.

Selecting and Managing Clinical Contract Research Organizations (CROs)

Identify the requirements for selecting CROs and other service providers. Identify the requirements for effectively managing CROs and other service ...

Ethical Review Boards

Recognize the key events that helped establish the ethical review system. Recognize the membership requirements of an IRB/IEC and the procedures ...

GCP/ICH Obligations of Sponsors, Monitors, and Investigators

Identify the specific obligations of sponsors, monitors, investigators, and their staff in protecting the rights and welfare of human subjects who ...

Implementing an Equipment Qualification Program

Identify the importance of equipment qualification. Recognize the GMP requirements for equipment qualification.

Environmental Control and Monitoring

Recognize the definition of environmental control and environmental monitoring. Recognize how cleanrooms are classified according to International ...

Orientation to GMP Compliance

Recognize regulations and their importance to your industry. Identify basic GMP requirements and your roles and responsibilities for compliance. ...

Handling a Product Recall

Recognize the definition of “product recall.” Recognize when a product recall is required. Recognize the impact of a product recall on a ...

GxPs

Recognize what practices comprise the GxP regulations. Recognize how these practices relate to each step in the development and manufacture of new ...

Gowning for Sterile Manufacturing

Identify the sources and types of contamination in a manufacturing environment. Recognize the importance of health issues and personal hygiene. ...

Writing Validation Protocols

Identify what validation protocols are. Identify the three types of qualifications and their properties. Recognize the key elements involved in ...

Maintenance and Cleaning of Drug Manufacturing Equipment

Recognize sound practices for equipment maintenance and cleaning and how these will meet the GMP regulations.

Basics of Cleanroom Operations

Recognize how cleanrooms are designed, validated, and operated.

Recruitment and Retention of Study Patients

Identify acceptable ethical and regulatory recruitment and retention methods that can be used for clinical research trials. Recognize key factors in ...

Aspects of Regulatory History

Recognize the historical events that brought about the regulatory requirements for conducting clinical trials. Identify the standards, ...

Clinical Trial Audits and Consequences of Non-Compliance

Identify the differences between a sponsor site audit and an FDA inspection. Recognize FDA standards for conducting and reporting clinical site ...

Overview of the Clinical Research Process

Identify what is entailed in the research process for new drug, biologic, and device products, including the documents submitted in order to gain ...

HIPAA -- The Impact On Clinical Research

Identify who is required to comply with HIPAA Privacy Rules. Recognize the roles of an institutional review board (IRB) and a privacy board (PB). ...

Obligations of Investigators in Conducting Medical Device Trials

Recognize the requirements for conducting medical device research including following a protocol, safety and reporting standards, and documentation ...

Business Practices to Protect Personal Health Information

Recognize the basics of our privacy and security practices. Recognize your roles and responsibilities related to health information.

GCP/ICH Obligations of Sponsors and Monitors

Recognize the roles and responsibilities of sponsors and monitors in clinical trials. Identify regulatory requirements, the types of personnel ...

Introduction to Data Integrity

Recognize the definition of data integrity as it pertains to a pharmaceuticals manufacturing environment. Identify regulatory requirements for data ...

European Union Clinical Trials Directive

Identify the principal elements of the EU Clinical Trials Regulation and Good Clinical Practice Directive.

MAPD: Enrollment

Identify the beneficiary eligibility criteria for Medicare Advantage plan enrollment. Identify the key concepts, principles, and the Medicare ...

Medicare Part D: Medication Therapy Management and Quality Improvement Program

Identify the primary cost control provisions. Identify the quality assurance requirements applicable to Part D sponsors. Identify processes CMS has ...

Medicare Advantage: Overview of the Medicare Program

Recognize the purpose of Medicare. Identify the primary Medicare coverage options and their requirements. Recognize the role of the Federal ...