Survival Kit for Regulatory Inspections

FDA Survival Kit - Regulatory Inspections

Having the FDA or other regulatory agency arrive to conduct an inspection can be stressful, even terrifying! Being caught off-guard can lead to severe consequences.

BE PREPARED FOR YOUR NEXT FDA INSPECTION

Our Survival Kit for Regulatory Inspections is the answer. Designed to help you develop an Action Plan so that you're totally prepared for your next inspection.

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.

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

 

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Getting Ready: General Preparations, Pre-Inspection Auditing, Pre-Approval Inspection Preparation, and Systems-based Inspections

Key topics that will be covered include:

  • How to organize your site preparations
  • How to use internal auditing effectively (also applicable to routine Self Inspections)
  • How to prepare (specifically) for a Pre-Approval Inspection
  • What to expect of a system-based inspection at a manufacturing site
  • How to set expectations among management and staff

Seminar Outline

Part I - General Preparation

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

Part II - Pre-inspection Auditing

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

Part III - 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 IV - Systems-based Approach to General GMP Compliance Inspection (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.

 

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

Key topics that will be covered include:

Inspection Room

  • How to organize the Inspection Room and get off to a good start
  • How to communicate with the Control Room
  • How to manage roles and responsibilities
  • How to handle daily wash-up meetings and the close-out meeting
  • How to communicate to the rest of the site/company

Control Room

  • How to organize the Control Room – layout, technology and personnel
  • How to prepare staff to contribute in the inspection room
  • What documents to prepare and how to control them

Seminar Outline

Part I 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 II Control Room Management

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

 

Staff Training and Preparation for a Regulatory Inspection

Key topics that will be covered include:

  • Staff Training and Preparation
  • Facing the inspector – Competent, Confident, Credible, Knowledgeable
  • Use of high level presentations
  • Likely targets Know and respect the inspector’s techniques
  • Behaviors to encourage
  • Behaviors to avoid

Seminar Outline

Part I - How to Face the Inspector and Interact Effectively

  • 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

 

David Inglis, Ph.D.

Dr. David Inglis is director of Ulverston GMP Consulting Ltd, specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning/decontamination, especially in bulk intermediates and APIs. He has a higher degree (Ph.D.) in enzyme chemistry (affinity chromatography).

During more than three decades in Quality Assurance in the pharmaceutical industry, Dr Inglis has gained extensive experience of Quality Management, through roles in QA laboratories, GMP compliance and regulatory compliance. He successfully pioneered automated HPLC methods, and then managed all aspects of QC laboratories before spending the following 11 years managing and developing Quality Assurance, including documentation, control of change, auditing and routine regulatory compliance to cGMP. He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates in clinical trials and for medicinal products imported into the EU.

Dr Inglis is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for FDA/MHRA inspections, including FDA Systems- based inspections. He has extensive experience of being the lead spokesman during major regulatory inspections.

Dr Inglis is a specialist in cGMP training and QA system improvement. His flagship improvement package details a system of secure GMP compliance at competitive cost. For conceiving and developing this package, Dr Inglis received the highest level of recognition for excellence from a global pharmaceutical manufacturing company.