Joshua Sharfstein, MD, FDA Principal Deputy Commissioner, gave a speech on Oct 22, 2009 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."
Outsourcing has become a bigger part of our industry. This seminar will define what it means to use third party vendors and the reasons to use them. We will review the types of vendors or suppliers that may be needed, the reasons for outsourcing certain functions within the biopharmaceutical or medical device industry to such suppliers, and the regulatory imperatives associated with using outside vendors as defined in the CFR, ICH Guidance and ASTM E-2500.
You will learn a formalized approach to identify the need for outside service providers, how to qualify third party vendors, getting the process outsourced to the selected supplier, and engaging as well as managing your supplier. We will review some of the advantages of outsourcing as well as the perils and pitfalls to avoid.
We will discuss make-buy analysis, request for proposals (RFP) and their content, the need to conduct supplier audits, and eventual benchmarking of services’ quality and cost. The seminar will touch on all aspects of identifying, qualifying, engaging and managing third party suppliers in the FDA regulated industries. We will also discuss some of the contractual issues and ending the relationship between you and your supplier.
Part I The need to outsource
- Why outsource
- How to define the scope of services you need outsourced
- What you should do to identify potential suppliers
- What advantages does a good third party supplier provide and what are the risks associated with choosing a bad supplier
Part II Identifying, qualifying, engaging and managing your supplier
- Learn how to define your needs and why to seek outsourcing
- Learn what the GMP regulatory requirements are
- Learn how to identify potential suppliers or vendors
- Learn how to use outsourcing to mitigate risk
- Learn what you need to do to qualify potential suppliers
- Learn how to prepare a RFP
- Learn how to select your supplier and mange his performance
- Learn how to track your supplier’s performance
FEE: PRICED PER PERSON
Call for group discounts for multiple participants at your company.
Instructor: Gamal Amer, Ph. D.
Dr. 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 30 years of 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.
