Cost Effective and Convenient - in your office or conference room

How to Conduct Successful Supplier Audits:
Protecting Your Supply Chain

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

November 13, 2009
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Joshua Sharfstein, MD, FDA Principal Deputy Commissioner, gave a speech on Oct 22 where he addressed the safety of the supply chain. Here’s an excerpt from his speech.

“What keeps Dr. Hamburg and me up at night should worry you as well - the safety of the supply chain in an increasingly globalized world. There are criminals out there who will dilute your ingredients with dangerous additives - from melamine to diethylene glycol to lead and arsenic. There are criminals who might claim to sell you one chemical and actually provide another. Because you are ultimately responsible for the product you put on the market and its impact on consumers, every company should be responsible for where you are purchasing ingredients."

When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical.  One of the tools at your disposal to verify the supplier’s acceptability is to audit its operation.

This seminar is designed to provide the participants a working knowledge of supplier audits. The seminar will review the why, when, who, how, and what of conducting a supplier audit to ensure that your supplier is capable of meeting all of your expectations.  This is a first step in selecting the correct supplier to meet your outsourcing needs.

By participating in this presentation you will learn:

• Why audit your supplier?
• Who will audit your supplier?
• When will you audit your supplier?
• What will you audit?
• How will you conduct the audit;
  as well as the following:
• How to prepare a Pre-audit questionnaire
• Areas to be audited and using check lists
• How to conduct effective close out meetings
• The advantages and disadvantages of using numerical audit scores
• Issuing observation reports and recommendations to your management and to your potential supplier

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.

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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 GMP091113E - MP3 audio file and Handout materials Conducting Successful Supplier Audits

$397.00

Instructor

Gamal Amer, Ph.D.

Gamal Amer, 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.

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