Dietary Supplement GMP (21 CFR Part 111)

Service Description

Dietary Supplement GMP (21 CFR Part 111) – Practical Implementation Course Description: This intensive three-day training provides a practical, hands-on approach to implementing and maintaining compliance with FDA Current Good Manufacturing Practice (cGMP) requirements for Dietary Supplements under 21 CFR Part 111. Participants will move beyond regulatory theory to learn how to establish, operate, assess, and improve GMP systems within dietary supplement manufacturing, packaging, labeling, testing, and distribution operations. Learning Objectives: Upon completion of this training, participants will be able to: Interpreting and applying FDA dietary supplement GMP requirements Develop and maintain compliant quality systems Establish specifications and quality control procedures Create and manage GMP documentation Conduct investigations and implement CAPA Qualify suppliers and manage incoming materials Preparing for FDA inspections Identify and remediate common compliance gaps Develop practical action plans for GMP implementation Target Audience: This course is intended for: Quality and Compliance Personnel Manufacturing Operations Personnel Regulatory and Technical Personnel Executive Leadership Contract Manufacturing Organizations (CMOs) Course Topics: Understanding the Structure of Part 111 Personnel, Facilities, Equipment, and Sanitation Requirements Quality Systems and Quality Control Operations Requirements and Responsibilities Documentation Systems and Record Management Requirements Specifications and Material Controls Receiving, Sampling, and Testing Requirements Master Manufacturing Records (MMRs) Batch Production Records (BPRs) Packaging and Labeling Controls Deviations, Investigations, and CAPA Complaint Handling and Product Recalls Internal Audits and Self-Inspections FDA Inspections and Enforcement Trends Mock FDA Inspection and Action Planning Certificate: Participants who successfully complete the training will receive a Certificate of Completion for Dietary Supplement GMP (21 CFR Part 111) – Practical Implementation.