Overview of FDA cGMP Compliance for Drugs and Biotech Products

Course Description
This course was developed for those employees in the pharmaceutical industry who need to have the basic understanding of Current Good Manufacturing Practices.

Learning Objectives
This course will provide each attendee with the background and knowledge necessary to understand the organization, structure and role of the FDA as it relates to compliance issues dealing with drug and biotech products. The course also covers the remedies available to satisfy the FDA that processes and guidelines are fully in compliance.

After this training course you will be able to:

• Define essential job functions and compare QA vs. QC
• Understand regulatory requirements including narrowed scope of 21 CFR Part 210/211
• Understand regulatory requirements including narrowed scope of 21 CFR Part 600
• Understand regulatory requirements including narrowed scope of 21 CFR Part 11
• Utilize statistical tools for the Quality Assurance job function
• Annual Product Review requirements
• Change Control Requirements
• How to evaluate and monitor suppliers and vendors
• Ensure documentation control is within cGMP compliance
• Identify current FDA trigger points
• Hosting an FDA Inspection
• Communication with the FDA

COURSE AGENDA

FIRST DAY
Module 1: The FDA Organization & Tools for Regulating Drugs and Biotech Drugs
FDA Structure and Organization
- Regulations and the Law
- FDA Guidelines
Administrative Enforcement Tools
- 483 Lists of Observations
- Warning Letters Legal Enforcement Tools Investigator Education & Training Inspection Planning Review of the Systems Approach to Drug Inspections

Module 2: Documentation Essentials
Controlling Documents
Document Problems
GMP Records
Compliance Within Established Standards

Module 3: Ensuring Good Manufacturing Practices for Drug Products
CGMP General Provisions
Flexible Enforcement
ICH Guidance Documents: ICH Q8 & ICHQ9 SECOND DAY

Module 4: Annual Reports
Annual Reports Annual Product Reviews (APRs) Introduction to Annual Product Reviews Define Roles and Responsibilities Identify Needed Documentation for APRs Data Collection Methods for Complaints, Recalls, Deviations, Changes, CAPA, Returned Product , and Investigations Data How to use APRs to Improve Process and Product Quality Analyze FDA Enforcement Trends Change Control: o Types of Change Control o Impact Assessment o Implementation Practices o Validation/Verification of Changes
Module 5: GMPs for New Chemical Entities
Applicability of CGMPs
Regulations
QA/QC
Documentation
Equipment and Facilities
Raw Material Control
Production Process Control
Process Validation

Module 6: Hosting An FDA Inspection and Triaging Your FDA - 483
Company Policy
Written Procedures
Inspection Environment
How to Prepare Personnel for the Inspection
Daily Debriefings
Corrective Actions
Closing Meeting
What Should and Should Not be Listed
Developing the Initial Response
Timeliness of Response
Meetings with the FDA
Warning Letters
Dispute Resolution Process & Who to Communicate With
Questions & Wrap-Up

When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization, department or employees functional responsibility.