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
