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How to Manage Regulatory Inspections
Managing the Inspection Room and the Control (War) Room
Conducted by David Inglis, Ph.D.
Ulverston GMP Consulting Ltd.
February 5, 2010
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 David Inglis, PhD, an experienced practitioner with three decades in the pharmaceutical industry, you will learn the key principles of the organization of the Inspection Room and Control Room (often known as the War Room). A future seminar will address the preparation of staff who will be expected to face the inspector(s).
This seminar was developed to help participants to determine what actions are needed to build a robust system for handling regulatory inspections.
Key topics that will be covered include:
- 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
- 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
This seminar is presented by Dr. David Inglis. David will discuss how you can prepare thoroughly for regulatory inspections to maximize the potential for success during the inspection for your manufacturing site.
BONUS RESOURCE DOCUMENTS (sent via email the day before the seminar)
- Pre-inspection CAPA tracking worksheet
- Preparation matrix for regulatory inspections
- Checklist of typical documents for FDA's systems-based inspections
How to Manage the Inspection Room and the
Control (War) Room during Regulatory Inspections
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
Part III Questions and Answers
- Dr. Inglis will field your questions live on the phone. You will hear all questions and answers from all participants of this seminar.
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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the presentation handout materials the day before the seminar.
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GMP100205E - MP3 audio file and Handout materials
How to Manage the Inspection and Control Rooms during Regulatory Inspections
David Inglis, Ph.D.
Dr. David Ingls 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.
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