Ensuring an Effective Design of Cleanroom and Facility Validation Compliant with FDA Regulations

When designing a cleanroom, many factors should be considered to adequately implement the requirements for an effective cleanroom design and validation. Otherwise, it can be costly and time-consuming later.

This webinar is intended to discuss FDA regulations and the requirements for an effective cleanroom and facility validation as part of current good manufacturing practices (CGMP) for sterile drug and biological products.

Understand what firms should know about the statutory and regulatory requirements so that the industry can implement good manufacturing practices to ensure an effective cleanroom design and validation. This session will greatly help you understand and establish an effective environmental monitoring program in view of CGMP (USP, ISO and FDA recommendations).

Areas Covered in the Session :

  • Applicable Laws and Regulations
  • Key Definitions
  • CGMP Practice Requirements for the Pharmaceutical Industry
  • Regulations Governing Buildings and Facilities
  • International Standards and Guidance Documents: ISO, USP, and FDA
  • Comparative Overview of Air and Cleanroom Classification: FDA, ISO and EU EMA
  • What to Consider When Designing a Cleanroom
  • Cleanroom Validation: Principles and Testing
  • Determining What Tests to Perform During a Cleanroom Validation
  • Key Requirements for Personnel Training, Qualification and Monitoring
  • Important Laboratory Controls
  • Implementing an Effective Monitoring Program
  • FDA Enforcement Actions
  • PASS-IT Suggestions

Who Will Benefit:

  • Professionals from the healthcare industry: drugs, biologics, medical devices/IVDs, Combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • R&D Professionals
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance