cGMP - FDA Regulations and Current Good Manufacturing Practices

Corporate Program

Instructor: Dr. James Dittami and Industry Experts

Develop your knowledge of FDA regulations and current good manufacturing practices (cGMP) with this corporate program. The program can be tailored to suit your business needs; covering Medical Devices, Pharmaceuticals, or both.

Key Topics Include

Overview of the FDA
FDA Approval Process

Pharmaceuticals

Investigational New Drug Application (IND)
New Drug Application (NDA), ANDAs
Research Phases, Clinical Trials, OTC drugs
Post Approval, Labeling, Off-Label Promotion and Use, Marketing

Medical Devices

Classifications, Combination Products
Investigational Device Exemption (IDE), Premarket Approval (PMA), 510Ks, Post Approval, Marketing, Post-Market Surveillance

Regulation of FDA Manufacturing

Roles and Responsibilities of Drug Manufacturing
cGMPs, Pharmaceuticals and Medical Devices
Requirements for Facilities and Equipment
Shifting Trends in Compliance
Production and Process Controls
Control of Product Containers and Closures
Packaging and Labeling Control
Obligations to be forthcoming
Violations and Enforcement

Who Should Attend

This program is ideal for anyone interested in starting a career in an FDA regulated environment or for anyone new to the pharmaceutical or medical device fields.

This program is available for delivery at YOUR corporate site. Please contact WPI Corporate and Professional Education to learn more about corporate delivery of the cGMP program at 508-831-5517or cpe@wpi.edu.

Maintained by webmaster@wpi.edu
Last modified: April 08, 2008 08:44:44