8 hour class delivered in two 4-hour modules, 7/27 and 7/28 from 8 a.m. to 12 p.m.

Overview:
Building upon Overview of FDA and Quality Systems Overview courses, this course goes beyond the basics and uses interactive exercises to understand and apply current Good Manufacturing Practice (cGMP) regulations for pharmaceutical, biopharmaceutical and medical device industries. This course will dive into the details of 21 CFR Parts 210, 211, & 820, ICHQ7, and the EU GMP guidelines. Participants will benefit from real world examples and lessons learned to use risk-based and scientific principles to ensure product quality throughout the production lifecycle. This course will guide participants through the six system inspection model: Quality Systems, Materials, Packaging and Labeling, Production, Facilities & Equipment, and Laboratory Controls, to provide them with appropriate strategies for ensuring compliance.

By the end of the course, participants will be able to:

Apply cGMPs to their specific job responsibilities beyond the basic elements.
Establish and maintain a quality system that builds quality into the product and allows for implementation of continual improvement.
Understand and interpret cGMPs in a practical manner to be able to apply the “right-sized” Quality Systems and GMPs to fit the specific environment, taking into account factors such as scope of operations, complexity of processes, and appropriate use of finite resources.
Discuss specific requirements and strategies for compliance with 21 CFR Parts 210, 211, & 820, ICHQ7, and the EU GMP guidelines.
Define each of the six-system elements: Quality Systems, Materials, Packaging and Labeling, Production, Facilities & Equipment, and Laboratory Controls
Course Outline:

Quality Systems
Note: Other courses in the certificate program will provide greater detail in Quality Systems such as CAPA, Change Control, Deviation Management, and Quality Risk Management.
Organization and Personnel
Documentation (Records and Reports)
Control of Materials
Production Controls
Facilities and Equipment
Packaging and Labeling
Laboratory Controls

Who Should Attend:
Quality assurance, quality control, regulatory affairs, validation, manufacturing, technical support, IT, supply chain, and engineering professionals in the pharmaceutical, biopharmaceutical, or medical device industry.
All levels of management who require a refresher course to stay current with GMP regulations and learn from case studies. Service providers and vendors who serve pharmaceutical, biopharmaceutical or medical device industry clients.

Prerequisites:
No prerequisites.