Current Good Manufacturing Practices (cGMPs) for the Medical Device Industry

Good manufacturing practices are the regulations enforced by the United States Food and Drug Administration (FDA) for medical devices. They are often referred to as current Good Manufacturing Practices (cGMP's), and provide the systems and the framework to assure proper design, monitoring, and control of manufacturing processes and facilities. This course will provide an overview of medical device cGMP's. Attendees will also gain knowledge of what constitutes a medical device, a brief overview of the risk classification of medical devices, management's role in the implementation of cGMP's, and the importance of good documentation practices.

Instructor Biography

Wayner Williams: Wayner has earned a Bachelor of Science degree in Chemical Engineering, a Masters in Materials Science and Engineering, a Masters in Pharmacy and a certification in Drug Regulatory Affairs from the Department of Pharmaceutical Outcomes and Policy.  She has over 23 years of experience in global medical device and pharmaceutical product development, regulatory affairs and quality system compliance.  She has worked within the Johnson and Johnson family of companies in multiple areas of accountability including formulation development, new product development, new product project management, developing and implementing quality systems, design control and implementing product lifecycle management systems which interconnect and render useable all of the data required to demonstrate quality system compliance to regulatory bodies.  She has also worked with multiple device types and combination drug/device products for companies ranging from Fortune 500 to small startups.

Wayner has conducted many training and teaching engagements ranging from regulatory and quality system training to skills essential for success in new product development and other cross functional fields of interest.