GMP Compliance, Regulatory Affairs & Validation

Course Summary

Participants will learn about principles of cGMP applied to product analysis and discovery, development, manufacturing, verification and validation.

Event Details

8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization

Description

In the United States, a government agency, the Food and Drug Administration (FDA), establishes regulations that govern the sale of food, drugs, biologics and medical devices. FDA requires that manufacturers in these industries establish and maintain quality systems to ensure that their products meet the usability and safety needs of their customers. Quality systems for products that are governed by the FDA are based on Good Manufacturing Practices or GMPs.

The GMP compliance requirements for medical devices are outlined in the Code of Federal Regulations (CFR), most prominently in the FDA Quality System Regulations of 21 CFR Part 820. This part establishes the requirement for quality systems in medical device companies, mandating quality procedures such as design controls, CAPA process, quality assurance and quality control activities, document controls and more.

GMP Training requirements also include other portions of the CFR. 21 CFR Part 812 deals with investigational device exemptions, allowing devices to be shipped lawfully for the purpose of clinical investigations when they would otherwise be required to comply with a performance standard or to have premarket approval. 21 CFR Part 808 addresses exemptions from Federal regulation of state and local medical device requirements.

Who Should Attend

Engineers, PMs, quality assurance professional, quality control managers, regulatory affairs, auditors, production engineers and managers, and management would like to apply current GMP compliance tools and techniques to their environment.

Learning Objectives

This cGMP training course is designed for anyone who needs a good understanding of current Good Manufacturing Practices. Learn about cGMP environment, procedures and processes, roles and responsibilities applied to cGMP quality. Participants will learn about principles of cGMP applied to product analysis and discovery, development, manufacturing, verification and validation.

Course Outline

  • What is cGMP?
  • Quality Unit Responsibility and Authority
  • Personnel Training and Responsibilities
  • Annual Product Reviews/Internal Audits/CAPA
  • Complaint Handling
  • Change Control
  • Recalls/Returns/Salvages
  • Stability Testing
  • Validation
  • Traceability
  • Facility and Equipment
  • Material System and Supplier Qualification
  • Production System
  • Packaging and Labeling System
  • Laboratory System

Prerequisites

None

Instructors

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