The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Length
60 minutes
Product Description

FDA Requirements for Water Systems Validation from a Microbiological Aspect for Drug, Biologics and Medical Device Manufacturing

There are eight types of water used in manufacturing drug products. And, it is of paramount importance to design, validate and control water systems used in the manufacture of drugs, biologics and medical devices.

This session by our expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, is intended to discuss FDA requirements for water systems from a microbiological aspect for drugs, biologics and medical devices.  In particular, it is intended to discuss microbial control, monitoring and validation of water systems.

This presentation will provide great opportunities for industry professionals to be better aware of and get more familiar with the FDA’s expectations for establishing water systems suitable for use in the manufacture of drugs, biologics and medical devices.

Session Highlights:

  • Applicable Laws and Regulations
  • Definitions
  • Types of Medical Products
  • Key Considerations for Designing a Water System
  • Types of Water Used in the Manufacture of Drug Products
  • Different Types of Water Required for Different Types of Products
  • Water System Design: Acceptable Methods
  • Types of Water Required for Inhalation, Ophthalmic or Parenteral Products, etc.
  • What to Consider for Water System Validation
  • Water System Validation
  • Common Problems
  • Microbial Control for Different Types of Water
  • Acceptance Criteria
  • Water Sampling
  • PASS-IT Recommendations

Who should attend?

  • Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Compliance Officers
  • Radiation Safety Officers
  • Laboratory Personnel
  • R&D
  • 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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