-
@webinargct77editor·
Orphan Drug Regulation: Value-Added IP and Global Opportunities
This course covers orphan drug regulations in the USA and EU, examining similar regulatory areas and orphan opportunities elsewhere. It details requirements, applications to your technology, and common application errors, including SDS format.
-
@webinargct77editor·
Ensuring Supplier Requirements for a Successful FDA Inspection: Auditing…
This webinar focuses on purchasing control requirements and supplier auditing to ensure proper procedures are established and maintained. Includes information on the Safety Data Sheets (SDS) format.
-
@webinargct77editor·
Batch Production Record and Device History Record Review and Quality Assessment
Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates…
-
@webinargct77editor·
Electronic Records & Electronic Signatures: Basic Concepts
This presentation covers 21 CFR Part 11, and basic concepts of electronic records and electronic signatures. It also covers labeling requirements and Safety Data Sheet formats.
-
@webinargct77editor·
Hazard Communication Standard (HAZCOM)
An overview of the Hazard Communication Standard (HazCom); worker-right-to-know labeling requirements and Safety Data Sheets (SDS) format.
-
@webinargct77editor·
CAPA and Design Control Procedures for Medical Devices
This webinar provides guidance on understanding and implementing design control and CAPA system requirements for medical devices, including IVDs.
-
@webinargct77editor·
Regulatory Master Files for Investigational Products
Description of the stages and sections of a Master Regulatory File (MRF) System for investigational products during development and application.
-
@webinargct77editor·
Review of the Anti-Kickback Statute
This webinar provides an in-depth review of the Anti-Kickback Statute, focusing on prohibited actions and exceptions, and reviews relevant case law.
-
@webinargct77editor·
Root Cause Analysis and CAPA for Effective Investigations
This webinar focuses on using Root Cause Analysis and Corrective and Preventive Action to address atypical investigation and out-of-specification results.
-
@webinargct77editor·