GMPs in the Twenty First Century

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Feb 07, 2017
90 minutes
Product Description

Recent FDA Observations and Regulatory Emphasis on Science and Risk and its Current Interpretation of the GMPs

In 2001 the FDA announced to the pharmaceutical industry that it would regulate the industry based on good science risk. Since that time the Agency has partnered with ICH in the release of ICH Q8, Pharmaceutical Development, ICH Q9, Risk Management and ICH Q10, The Pharmaceutical Quality System. FDA has also issued guidance on Process Validation, Quality Metrics and Data Integrity. All of these provide contemporary interpretation for a quality system approach to the enforcement of the existing regulation, the drug GMPs, 21CFR211.

Although the drug GMPs have been in effect for more than thirty five years, the FDA regulates based on the current interpretation of that regulation. This interpretation is communicated to the industry through guidance and demonstrated through inspectional observations.

In this webinar expert speaker Jerry Lanese, there will be discussion on guidance issued by the FDA since the turn of the century and how these bring a contemporary interpretation to the drug GMPs. The discussion will be enforced by recent observations which will be used to clarify the regulatory emphasis on science and risk and its current interpretation of the GMPS.

Session Highlights:

  • The application of risk evaluation to pharmaceutical operations
  • The product lifecycle
  • The Pharmaceutical Quality System
  • Pharmaceutical Development
  • Process Validation
  • Quality Metrics
  • Data Integrity

Session Agenda:

  • ICH Q8; Pharmaceutical Development
  • ICH Q9; Quality Risk Management
  • ICH Q10; The Pharmaceutical Quality System
  • Guidance for the Industry, Process Validation
  • Guidance for the Industry; Quality Metrics (Draft)
  • Guidance for the Industry; Data Integrity (Draft)

Who Should Attend

  • Senior management
  • Quality Assurance and Quality Control management
  • Operations management
  • Line personnel in Quality and Operations

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...   More Info
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