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Effectively Implementing CAPA
Corrective and Preventive Action:
A Risk Mitigating Quality System

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

August 7, 2009

The prevalent method defined by the regulators (FDA, EU, …) and the industry for defining and mitigating risk is “Corrective and Preventive Action,” otherwise referred to as CAPA. This seminar will help you define what is meant by risk. We will explore the factors associated with compliance risk. Then we will explore risk causing events and how to address them. A review of risk level will be discussed. Upon completion of the risk part of the presentation we will define what a CAPA system would look like.

This seminar will focus on CAPA as it applies to risk mitigation. We will define what we mean by a CAPA system. We will further define the tools CAPA uses during implementation. Finally an overview of a CAPA system will be presented and a CAPA approach will be proposed. The approach will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system. We will then review some of the benefits which may accrue by having a robust CAPA system in place.

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.

Effectively Implementing CAPA (Corrective and Preventive Action): A Risk Mitigating Quality System

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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 web location to download the handout materials.

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Get the MP3 file and handout GMP090807E - MP3 audio file and Handout materials Effectively Implementing CAPA

$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.