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 ...

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 ...

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 ...

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 ...

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 ...

Privacy and Data Protection

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

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 ...

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 ...

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 ...

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), ...

Introduction to GMPs

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

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 ...

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 ...

Handling an FDA Inspection

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

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 ...

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 ...

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 ...

Laboratory Safety

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

PPE Assessment

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

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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, ...

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 ...

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 ...

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 ...

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 ...

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 ...

Writing Validation Protocols

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

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 ...

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 ...

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 ...

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 ...