Cost Effective and Convenient - in your office or conference room

How to Manage Regulatory Inspections

Staff Training and Preparation for a Regulatory Inspection

Conducted by David Inglis, Ph.D.
Ulverston GMP Consulting Ltd.

February 19, 2010
Scroll down to register

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 preparation of staff who will be expected to face the inspector(s). Previous seminars addressed General Preparation and Managing the Inspection and Control Rooms during the inspection.

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:

• 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

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.

In this unique web seminar format conducted on the telephone, lasting just one hour, you will be able to follow along with a handout presentation file, ask questions, and interact with Dr. Inglis. An outline of this seminar and Dr. Inglis' qualifications can be found below. The handout presentation file will be sent to you via email the day before the seminar.

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

Staff Training and Preparation for a Regulatory Inspection

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

Part II - 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.

Register now!

Don’t like to order online? Call us at 714-289-1233

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.

We accept Visa, MasterCard, and American Express (AMEX). All prices are in US dollars.

Note: Our shopping cart is set to the highest security level. Please make sure that the address corresponds to the credit card holder. It may result in a declined order if the address doesn't match the address on file for the cardholder named on the credit card.

Please enter your billing information EXACTLY as it appears on your credit card statement.

Get the MP3 file and handout GMP100219E - MP3 audio file and Handout materials Staff Training and Preparation for a Regulatory Inspection	$397.00

Instructor

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.

Please forward this to your colleagues who may be interested.