The Code of Federal Regulations (CFR) states: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuous basis and with sufficient frequency to ensure that employees remain familiar with cGMP requirements." In this On Demand course (part 2 of 11), you will learn the elements for ensuring organizational structure and workforce, as required by regulation.
Included in the GMP Refresher Certificate Program
The ISPE Academy’s comprehensive GMP Certificate program includes a mandatory GMP refresher course and allows learners to customize their learning experience by selecting two out of eleven GMP Fundamentals modules. Learn More and Register
Interactive Course: What to Expect
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.
Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.
Benefits include:
Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
Member-only discounts on Guidance Documents, Conferences, and Training
Pharmaceutical Engineering® magazine
Communities of Practice access to pharma professionals in specific topics from around the world