Raw Materials Risk Management in GMP Facilities: Avoiding GMP Non-Compliance Due to Raw Material Issues

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

All you need to Know about Raw Materials Risk Management in GMP Facilities and Avoid Non-compliance

Join this webinar by expert speaker John E. Lincoln to understand the requirements laid down by US FDA for the regulated medical products industry in areas like increasing globalization and extended supply chains when coupled with the need to have tighter internal materials controls. With what we can see in the recent headlines, the major problems of suppliers is caused by weak oversight of such sources. Poor cGMP, including change control or its lack, by vendors has resulted in major recalls and class action lawsuits. Due to this, U.S FDA cGMP has had a major shift in emphasis compliance audit, which affected various company response requirements, clinical trial expectations as well as product submissions. This change in focus towards increased emphasis on out-sourced, off-shore RM (raw material) / component vendors, has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success, with a major focus on the source, control, and documentation of raw materials, components, and even services. The cGMP compliance audit, 510(k) submissions / data, "better science", outsourcing / globalization and supply chain / control issues, and drug pedigrees, requests for offshore supplier information from domestic manufacturers, and recently established offshore U.S. FDA offices, reflect this growing concern. They are all part of a new, tougher stance on the supply chain by the U.S. FDA, and should get the same attention / focus by industry.

Join this session to understand the proven intent of the Agency in getting tougher in its expectations for the medical industry, that is, their internal controls, supply chain, and vendor compliance to the cGMPs, and based on “risk”. It will examine how these goals of the Agency have translated into action over the past several years: The changing focus of QSIT and ISO 14971:2007 and 2012, in medical device risk management, and ICH Q8, Q9, and Q10 re: pharmaceuticals; multi-site company operations, and the supply chain; Trends evident in 483 observations, Warning Letters, and recent major industry failures; Emphasis on proving a company is "in control" to an investigator's satisfaction regarding the integrity of its supply chain; and the negative role of "entropy". COA and COC, and vendor ranking models will be presented. The growing issues of product counterfeiting and drug pedigrees will be discussed.

Session Highlights:

  • The Globalization of the Regulated Medical Products Industry
  • The U.S. FDA's Shifting / New Emphasis
  • Core CGMP Expectations
  • Devices: QSIT and ISO 14971 focus
  • Pharma: Q10 Focus;  and Q8 and Q9 "Lessons"  
  • The Supply Chain
  • High Risk Areas -- Based on Recent 483s and Field Experiences
  • Risk Ranking Schemes
  • Pedigrees
  • Related FDA Strategic Priorities
  • Questions and Answers

Who Should Attend

  • Senior management in Drugs, Devices, Biologics, Combination products, Dietary Supplements
  • QA/RA
  • CROs and Clinicals personnel
  • Medical personnel and Other healthcare professionals, staff and office personnel
  • Consultants; others tasked with product, process, validations, CGMP responsibilities
  • Useful for members of AQC, RAPS, AAMI, etc.

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About Our Speaker

John E. Lincoln

John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation...   More Info
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