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

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Thu, Oct 29, 2015
60 minutes
Product Description

Learn About Statutory And Regulatory Requirements Applicable For Ensuring An Effective Cleanroom Design And Validation!

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 audio conference by expert speaker Dr. David Lim 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).

Session Highlights:

  • 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 should attend?

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


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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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