Introduction to 21 CFR 210 / 211 GMP's for Finished Pharmaceuticals Training

Description

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.

Objectives

This training provides a comprehensive overview of the regulatory requirements for the FDA’s Current Good Manufacturing Practice (cGMP) 21 CFR Part 210 and 21 CFR Part 211.

This course aims to:

• Improve your working knowledge of the regulations
• Discuss how to proactively reduce regulatory risks

Upon successful completion, you will be able to:

• Explain and define GMP and cGMP

• Discuss the role of the FDA in the cGMP process 

• Describe the types of inspections and potential outcomes for cGMP

• Understand and apply the information to your everyday roles and responsibilities

Audience

This course is intended for manufacturers, test laboratories, packagers(including pharmacies Directors, managers, supervisors, Engineers, Auditors, Manufacturing personnel, Quality Control and Assurance personnel, Corporate personnel supporting cGMP activities and Laboratory personnel.

Learners attending the virtual course option will need hardware, internet connection and telephone connection for the full duration of the course.