Supplier Audits
Avoiding Critical Risks when
Managing Raw Material Suppliers

An FDAnews FREE Webinar • Sponsored by ComplianceQuest
Thursday, Aug. 25, 2022 • 1:30 PM - 2:30 PM EDT

Raw Materials Are Not Fit For Use

These are some of the most dreaded words in Lifesciences. In this industry, manufacturers source many active ingredients, excipients, components, and in some instances raw materials from global suppliers to manufacture pharmaceutical products. Without proper due diligence, life sciences companies may wind up with a returned product that does not meet the necessary standards for quality. If the purchased raw materials do not meet the required quality and safety standards, there is a huge risk to patient safety that can lead to significant harm. The first step in applying any risk management process is understanding what a risk is. The term “Raw Material” is a general term, but it includes many different types of materials, including Active Pharmaceutical Ingredients (APIs), Critical Excipients, and Ancillary Materials.

The presentation will outline:

  • Regulatory Requirements for Raw Material Suppliers
  • Definitions of differ types of materials
  • Different Risk Attributes
  • How to consider Risk Attributes to manage suppliers using a risk-based approach
  • Conclusion

Who Will Benefit

  • Quality control
  • Supplier quality
  • Risk management
  • Regulatory affairs
  • Compliance
  • Material management

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Meet Your Presenter

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Bob Mehta

Principal Consultant at GMP ISO Expert Services

Bob Mehta is the Principal Consultant at GMP ISO Expert Services and provides consulting services in Pharmaceutical, Biotechnology, Medical Device, Active Pharmaceutical Ingredient, and Food/Dietary Supplement industries. Bob has over 28 years of experience, including as a Principal Consultant in the Quality Systems, Training, ISO 9001, ISO 13485, and Regulatory Compliance areas. Bob is a Fellow of American Society for Quality (ASQ) elected in November 2014. He has written educational articles in the areas of Quality and Compliance for the following publications: Medical Device & Manufacturing (MD&M), Pharmaceutical Technology, Quality Progress, and Nutraceutical World. He is an adjunct professor at California State University Dominguez Hills and California Polytechnic Pomona and teaches courses on Risk Management, Total Quality Management, Six Sigma Blackbelt, and FDA's Quality System Regulations. Bob has co-authored a book titled "Process Validation" and the book was published by ASQ Press in July 2016.

Bob authored the book "Implementing and Auditing ISO/IEC 17025:2017 A Practical Guide" which was published by ASQ Press in March 2019 and co-authored the book "Practical Process Validation which was published by ASQ Press in 2016.

Bob is the recipient of the 2017 Simon Collier Quality Award given by the ASQ Los Angeles Section.