The A to Z’s of Microbial Control, Monitoring and Validation of Water Systems

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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 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.

Areas Covered in the Session :

  • 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 Will Benefit:

  • Regulatory Affairs Departments
  • Clinical Affairs Departments
  • Quality Assurance Departments
  • Compliance Officers
  • Radiation Safety Officers
  • Laboratory Departments
  • Research & Development Departments
  • Consultants
  • Contractors/Subcontractors
  • Any professional 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