In House Training Course

How to Manage Regulatory Inspections

This seminar was developed to help participants to determine what actions are needed to build a robust system for handling regulatory inspections.

The key to effective management of regulatory inspections is effective preparation.  Being well organized and confident during the inspection means that your firm gives its best possible performance which in turn gives the regulatory inspector the clear message that you know your business thoroughly.

In this seminar, conducted by Dr David Inglis, an experienced practitioner with more than three decades in the pharmaceutical industry, you will learn the key principles of preparation of the manufacturing operations and site, the organization of the Inspection Room and Control Room (often known as the War Room) and preparation of staff who will be expected to face the inspector(s).

Section I:          Getting Ready: Pre-Inspection Auditing, Pre-Approval Inspection Preparation, and System-based Inspections

Part 1     General Preparations

• Documentation and systems review
• Reviewing manufacturing, engineering and QA/QC concerns
• Warehousing and distribution

Part 2     Pre-Inspection Auditing

• Purpose of the pre-inspection program
• Establishing the program
• Setting up the inspection teams
• Conducting the inspection and reporting

Part 3     PAI preparation (distinct from general GMP inspection preparation)

• Familiarity with submission
• Overview of product development
• Process flow diagram
• API information and critical quality characteristics

Part 4     Systems-based Approach to General GMP Compliance Inspections  (Drug Manufacturing Inspections)

• FDA systems-based approach to inspections of production facilities
• Inspection methods of other regulatory authorities
• Expectations of the Quality System
• Essential documentation and records for each part of the system.

Part 5     Questions and Answers

Workshop 1

Section II:         How to Manage the Inspection Room and the Control (War) Room during Regulatory Inspections

Part 1     Inspection Room Management

• Layout and equipment or technology
• Getting started
• Communications with the control room
• Daily wash-up sessions
• Communication with rest of site / company.
• Inspection close-out meeting

Part 2     Control Room Management

• Layout and equipment or technology
• Staff present / roles
• Preparation of documentation
• Document retrieval and review
• Preparation of experts

Part 3     Questions and Answers

Workshop 2

Section III:        Staff Training and Preparation

Part 1     How to Face the Inspector

• Facing the inspector – competent, confident, credible, knowledgeable
• Use of high level presentations
• Likely targets
• Know and respect the inspector’s techniques
• General inspection behaviors to encourage
• General inspection behaviors to avoid

Part 2     Questions and Answers

Bonus documents

• Pre-Inspection CAPA Tracking Worksheet
• Preparation Matrix for Regulatory Inspections
• Checklist of Typical Documents for FDA Systems-based Inspections

Speaker

Dr David Inglis