This presentation is intended to discuss current FDA requirements for pyrogen and endotoxins testing required for drugs, biologics and medical devices for regulatory purposes. In particular, it is intended to discuss FDA’s testing recommendations and acceptance criteria for appropriate components and finished products to be tested in view of available standards to the industry (e.g., drugs, medical devices, and biological products).
To obtain FDA approval or clearance for medical products, it is of paramount importance that firms accurately understand the requirements including common misinterpretation so that costly mistakes can be avoided.
This presentation will provide great opportunities for industry professionals to be better aware of and rather get more familiar with the current FDA testing requirements for drugs, biologics and medical devices concerning pyrogen and endotoxins testings.
The speaker will walk you through recent FDA requirements and common misconception for pyrogen and endotoxins testing for drugs, biologics and medical devices.
Areas Covered in the Session :
- Applicable Laws and Regulations
- Understand FDA’s Recommendations in the Past
- Common Misconception and Misinterpretation
- Current FDA Testing Requirements: Pyrogen and Endotoxins
- Requirements for Sampling, Storage, and Handling
- Monocyte Activation Test (MAT): When and Why
- Rabbit Pyrogen Test: When and Why
- Limulus Amoebocyte Lysate (LAL) Test: When and Why
- Retesting Requirements
- Standards for Consideration
- FDA Enforcement Actions
- Speaker’s PASS-IT Suggestions and Recommendations
Who Should Attend:
- Regulatory Affairs Departments
- Clinical Affairs Departments
- Quality Assurance Departments
- Compliance Officers
- Radiation Safety Officers
- Laboratory Personnel
- Research & Development Departments
Course Director: 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.