How to Achieve Validation Requirements for a Clean Room Manufacturing Environment


Instructor: John E Lincoln
Product ID: 706947
Training Level: Intermediate to Advanced

  • Duration: 90 Min
Both the U.S. FDA and EU's MDR expect documented risk-based clean room manufacturing environment per ISO 14644-series, ISO 14698-series (and the old FED-STD 209E).
Last Recorded Date: Feb-2024


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Review a company's clean room manufacturing environment verification and validation practices against industry standards / requirements. What are considered major cGMP deficiencie? Starting with a Master Validation Plan, evaluating its elements against ISO 14971 for hazard analysis and product risk management, allows the development of meaningful clean room manufacturing product quality-specific validations, starting at the desirn stage, through production, to and including de-commissioining. Also the roles of different V&V protocols; Controlled manufacturing, clean room manufacturing, equipment / process DQs, IQs, OQs, and PQs, or their equivalents. Field-tested examples of protocols and specific test cases are provided. Software / firmware V&V using a recently changed FDA software validation "model" are examined, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 and cybersecurity are considered where required.

Why Should You Attend:

FDA Warning Letters and recent high-profile manufacturing contamination issues regarding Covid 19 vacines and infant formula, resuling in some alleged deaths, indicate major cGMP deficiencies in contamination controls with several established manufacturers. What are the regulatory reauirements? The "must have" elements from the CGMPs and international standards for clean rooms, cross-contamination issues, and personnel behavior. Events prove none of these can be taken for granted.

Areas Covered in the Webinar:

Participants will learn how effective clean room validation methodologies are a critical requirement in developing and maintaining a compliant clean room manufacturing environment.
Issues to be covered include:

  • Assurance of product quality from CGMP compliant clean room validation and periodic monitoring activities.

  • US FDA and EU MDR / ISO requirements

  • Controlled manufacturing areas
  • Clean room classifications and their requirements

  • Required manufacturing adjustments and maintenance activities
  • On-going monitoring activity equipment; documentation
  • ISO 14644-series (replacing FED-STD 209E)
  • ISO 14698-series

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their controlled manufacturing / Clean Room manufacturing environments / facilities. While this presentation is focused on medical devices, many of its principles apply to personnel / companies in the Pharmaceutical, Diagnostic, and Biologics fields, including asceptic fill.
The employees who will benefit include:

  • Senior management
  • R&D
  • Quality Assurance / Regulatory Affairs
  • Production
  • Engineering, indluding Manufacturing and Facilities
  • All personnel involved in verification and/or validation planning, execution and documentation.
Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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 and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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