Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products

This course was developed for those employees in the pharmaceutical industry who are involved with ensuring regulatory compliance for drugs and biologics. Typical attendees include those in:

• Manufacturing/Production
• Regulatory Affairs
• Research and Development
• Quality Assurance & Control
• Development and Preparation of Submission Material
• Laboratory Operations

This course is designed for individuals who require an in-depth knowledge of regulatory affairs and compliance issues. The content is continually updated by our expert Course Directors.
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.

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 content is designed to provide an in-depth understanding of how the FDA performs inspections, the type of information they are looking to see in place and the variety of results that can occur from each inspection. The course also covers the remedies available to satisfy the FDA that processes and guidelines are fully in compliance.

Course Description

As with all CfPIE courses, our expert Course Directors regularly update the content of the course to reflect the latest FDA actions and compliance strategies. This course discusses the role played by the FDA, it's administrative and enforcement powers, its strategies towards compliance issues and how these affect operations within pharmaceutical, biotech and related industries.

Issues to be covered include:

• Structure of the FDA
• FDA Inspections
• Documentation
• The scope of FDA disciplinary actions
• How to develop and maintain strict compliance including:
- Policy guidelines
- Good CGMP practices
- Development of a standard compliance program
• Hosting an FDA Inspection
• Communication with the FDA

________________________________________

COURSE AGENDA

FIRST DAY

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

FDA Inspections

• Investigator Education & Training
• Inspection Planning
• Trade Secrets and Confidential Information
• Processing Violative Inspections
• Ensuring Good Manufacturing Practices for Drugs

Documentation Essentials

• Controlling Documents
• Document Problems
• GMP Records
• Compliance Within Established Standards

Ensuring Good Manufacturing Practices for Drug Products

• History of Regulatory Enforcement
• FDA Policy and Program Issues
• CGMP General Provisions
• OTC Drug Policy
• Flexible Enforcement
• API, Process Control Basics, Packaging Control Basics
• Guidance Documents
• Drug Compliance Programs

A Systems Approach to Drug Inspections

Practical Problems That May Result in FDA Enforcement

SECOND DAY

Pharmaceutical Development

• Key Development Steps
• Basic Research
• Research and Development Phase
• Regulated Phases
• Legal Requirements
- Pre-Clinical vs. Non-Clinical
• ICH Guidance

GMPs for New Chemical Entities
• Applicability of CGMPs
• Regulations
• QA/QC
• Documentation
• Equipment and Facilities
• Raw Material Control
• Production Process Control
• Process Validation

Bioresearch Monitoring Programs
• Legal Requirements
• Research and Marketing
• BIMO Program Objectives
• GLP Essentials
• Types of Inspections
• IRBs
• Sponsor – Programs and Responsibilities

Hosting An FDA Inspection
• Company Policy
• Written Procedures
• Inspection Environment
• Daily Debriefings
• Corrective Actions
• 483 Specifics
• Closing Meeting
• The Use of Mock Inspections

Triaging Your FDA-483
• What Should be Listed – What should Not Be Listed
• Developing the Initial Response
• Timeliness of Response
• Meetings with the FDA
• Warning Letters

Communicating with FDA
• Constraints
- Government/Legal
- Government/Administrative
- Industry
• Dispute Resolution Process
• Who to Communicate With
• Using Intermediaries

Questions & Wrap-Up