The New FDA Guidance on Quality Agreements and Effective Management of Contract Manufacturing

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

Understand FDA Guidance on Quality Agreements and Effective Contract Manufacturing Management

It is the responsibility of a manufacturer to assure that all its suppliers are compliant with FDA’s current GMP requirements applicable to their operations. Supplier management starts with appropriate qualification, contracts, and quality agreements, and requires continuing quality assurance (QA) practices including sampling and testing, and supplier audits. FDA compliant quality systems require a vigorous supplier qualification process and robust quality agreements with all suppliers. The recently proposed FDA draft guidance on quality agreements describes the relationship between owners and contractors, and defines all the expectations for both parties when it comes to complying with GMP requirements. This webinar by expert speaker Dr. Mukesh Kumar will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Also, common FDA findings related to suppliers during GMP audits will be discussed with potential remedies.

The session will also review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices, and discuss the content and structure of SOPs for supplier qualification and quality agreements. Common FDA audit findings will be discussed. A comparison of US and EU regulations will help identify the common themes across different regulatory agencies and offer ways to comply with them.

Training Objective:

  • Common FDA Audit findings
  • Regulatory requirements for supplier qualification
  • Responsibilities of manufacturers and suppliers
  • Risk Management Process (ICH Q9)
  • GMP Requirements apply to all Stakeholders
  • Best practices for supplier selection, qualification and management
  • What is FDA’s expectation with regards to Quality Agreements
  • What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance
  • Best practices for a good quality agreement
  • Supplier audits
  • Documentation requirements and audit trails
  • What to expect in the near future

Who Should Attend

  • Managers of GMP or QSR compliant manufacturers of drug, biologics and medical devices
  • Managers and QA personnel from Contract Manufacturing Organizations (CMOs)
  • Regulatory and quality professionals working for US companies that are considering the suppliers in non-US regions
  • Suppliers in non-US regions looking to US-based clients
  • QA/QC/Compliance/Regulatory affairs professionals
  • Regulatory compliance and quality professionals consulting with companies developing such products for the US market
  • Business professionals looking to understand the risks and benefits of investing in such products

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
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