Cost Effective and Convenient - in your office or conference room
How to Conduct a Successful Supplier Audit: Protecting Your Supply Chain
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
You receive the GotoMeeting MP4 file which includes the slides and audio from this seminar. You can save this file to your system. Use Windows Media Player or equivalent player to open and run this file. View in your office or gather your team in a conference room.
Recently FDA has been more rigorous in their enforcement of the cGMP regulations to significantly improve control over suppliers. Joshua Sharfstein, MD, former FDA Principal Deputy Commissioner, gave a speech where he addressed the safety of the supply chain. Here’s an excerpt from his speech.
“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 webinar is designed to provide the participants a working knowledge of supplier audits. Dr. Amer 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 webinar 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 suppliers
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How to Conduct a Successful Supplier Audit
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.
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