2020 - Quality Control Laboratory Compliance - cGMPs and GLPs
Date2020-04-16 - 2020-04-17
Deadline2020-04-06
VenueBoston, MA, USA - United States
KeywordsQC Lab regulations; FDA QC Lab requirements; Stability studies
Topics/Call fo Papers
Key goals of the conference will include learning:
The basics of FDA law and regulations governing QC laboratories responsible for testing research materials, components of FDA-regulated products, and finished FDA-regulated products (pharmaceuticals, biologics, medical devices, cosmetics, and foods).
Laboratory organization, personnel qualification and training requirements.
Documentation and record-keeping requirements, including e-records and data integrity.
Sample integrity requirements.
Management and control of stability (shelf-life) studies.
Analytical methods verification and validation.
Management and control of laboratory instruments.
Management and control of laboratory supplies.
Proper conduct of laboratory investigations.
Consequences of laboratory non-compliance.
The basics of FDA law and regulations governing QC laboratories responsible for testing research materials, components of FDA-regulated products, and finished FDA-regulated products (pharmaceuticals, biologics, medical devices, cosmetics, and foods).
Laboratory organization, personnel qualification and training requirements.
Documentation and record-keeping requirements, including e-records and data integrity.
Sample integrity requirements.
Management and control of stability (shelf-life) studies.
Analytical methods verification and validation.
Management and control of laboratory instruments.
Management and control of laboratory supplies.
Proper conduct of laboratory investigations.
Consequences of laboratory non-compliance.
Other CFPs
- REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
- Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)
- Risk Based Internal Auditing (RBIA)
- Managing Your FDA Inspection: Before, During and After
- Technical Writing for Pharma, Biotech and Medical Devices
Last modified: 2020-01-14 01:30:28