Survival Kit for Regulatory Inspections

Transcription

1 Creators of the GMP Ready-to-Use Training System 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 is the answer. Designed to help you develop an Action Plan so that you're totally prepared for your next inspection. Here's what you get in the kit: Three-hour seminar (on CD or MP3) conducted by David Inglis, Ph.D. (See below for details) Handouts for the seminar (over 100 slides) Checklist of Typical Documents required for FDA Systems-based Inspections General Preparation Matrix Plan CAPA form and Audit Action Tracker spreadsheet - Investigation and Correction of Quality Incidents/Nonconformities (CAPA - Corrective and Preventive Action) The value of this package is over $2,000 - Now available for only $797!

2 Creators of the GMP Ready-to-Use Training System Part ONE - How to Manage Regulatory Inspections Getting Ready: General Preparations, Pre-Inspection Auditing, Pre- Approval Inspection preparation, and Systems-based Inspections principles of preparation of the manufacturing operations and site. This seminar will cover: 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

3 Creators of the GMP Ready-to-Use Training System Part TWO - How to Manage the Inspection Room and the Control (War) Room during Regulatory Inspections principles of the organization of the Inspection Room and Control Room (often known as the War Room). 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

4 Creators of the GMP Ready-to-Use Training System Part THREE - How to Manage Regulatory Inspections: Staff Training and Preparation principles of the preparation of staff who will be expected to face the inspector(s). 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

5 Creators of the GMP Ready-to-Use Training System David Inglis, Ph.D. DR DAVID INGLIS is director of Ulverston GMP Consulting Ltd, specializing 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.