Cost Effective and Convenient - in your office or conference room

How to Implement FDA's New Guidance
on Process Validation

Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.

April 23, 2010

This seminar will focus on discussing the new FDA proposed (November 2008) guidance on Process Validation. The guidance promotes the implementation of a process-product life cycle approach to verification that the process is always in a validated state. The guidance defines three distinct stages to process validation. These are:

    Stage 1: Process Design
    Stage 2: Process Qualification
    Stage 3: Continued Process Verification

This is not a new concept, although the guidance may suggest it is. It was always important in the design and development of the process to consider GMP implications and keep validatability in mind. Process qualification or PQ was always the necessary step confirming that the process is capable of consistently producing a product that meets its predetermined specifications and quality attributes.

As for continuous process verification, this has always been a needed activity and was always accomplished through process and product monitoring. This seminar will review these phases and outlines approaches suggested for continuous process/product improvement.

In this unique web seminar format, lasting just one hour, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Dr. Amer. An outline of this seminar and Dr. Amer's qualifications can be found below.

Bonus Resource Document
FDA Guidance Document - Process Validation: General Principles and Practices

The handout presentation file will be sent to you via email the day before the 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 GMP100423E - MP3 audio file and Handout materials Implementing FDA's New Guidance on Process Validation	$397.00

Instructor

Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations.

Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.

Please forward this to your colleagues who may be interested.