WHO Good Distribution Practice (GDP) Introduction

During this interactive training, learn to interpret and apply the FDA requirements for production, quality systems and management of finished pharmaceuticals: 21 CFR 210 and 211.  Discuss ways to minimize or eliminate issues related to contamination, mix-ups, superpotency/subpotency, misbranding,  bio-availability, and safety and efficacy.These regulations apply to ingredients (API's and excipients) and finished dosage forms administered to humans and animals, OTC, Rx products, Biologics, and veterinary drugs.The FDA requires employees, contractors, and consultants supporting FDA cGMP activities to have sufficient education, training, and experience to perform their assigned functions. Annual cGMP training with effectiveness testing improves individual contributor working knowledge, skills, and effectiveness; helps to proactively reduce regulatory risks; and facilitates FDA compliance. Investing in FDA Compliance Training is essential to the qualifications, growth, and success of any individual wanting to support FDA-regulated activities.

This 1-Day course is designed through interactive training, for participants to learn to interpret and apply the FDA requirements for production, quality systems, and management of finished pharmaceuticals: 21 CFR 210 and 211. Learners will discuss ways to minimize or eliminate issues related to contamination, mix-ups, superpotency/sub-potency, misbranding, bioavailability, and safety and efficacy.

Through a series of discussion-based sessions and interactive workshops, learn how to help your organization demonstrate Good Manufacturing Practice (GMP) compliance using ISO 22716.  Build a strong foundation of knowledge and skills. Course Topics: Overview of GMP and the Standard  Clause 3 and Personnel Requirements  Clauses 4 and 5: Premises and Equipment Requirements  Clauses 6-11 and Documentation Requirements  Clauses 12-17 and Continual Improvement  Learning Review and Summary