This training program will provide regulatory requirements (US) of 21 CFR 111 for Dietary Supplements, 210/211 for Drugs, 820 for Medical Devices, and 4 for Combination Products, and will illustrate the key issues with examples. It will furnish details on what raw materials management from specification, purchasing, receipt, QC, storage, manufacturing, finished goods, and final QA quality management systems are mandated to address.
Areas Covered in the Webinar:
US FDA Regulatory Background
Intent of the CGMPs regarding Raw Materials and Risk Management
Responsibilities
Key Definitions
The RM chain and FDA expectations at each key control point
What Does 21 CFR Part 210 / 211 and 820 Require
Other CGMPs and RM issues
Related requirements of EU and ISO 13485
Document Control / Records Requirements
Who Will Benefit:
Regulatory Compliance Professionals
Quality Assurance Professionals
Quality Control Professionals
Supply Chain Personnel
Hazard Analysis and Risk Management Personnel
Complaint Handling Professionals
Purchasing Personnel
Attend Live Webinar
Apr 8, 2021 - 01:00 PM EDT
Duration: 90 Minutes
Visit website for register webinar