Quality Audits in the (Bio)Pharmaceutical and Device Industry

External and Internal Quality Audits in GMP manufacturing including the (bio)pharmaceutical and medical device industries are global regulatory compliance tools to ensure the safety and effectiveness of drugs, vaccines, other biological products, and devices. The course includes an overview of regulatory requirements, the different types of audits, and how to prepare for, conduct, and follow up on an audit. Special attention will be given to the internal audit which is a company's most important managerial tool for monitoring the quality of processes and products. Internal audits, when effectively implemented, are critical to the identification of weaknesses and the continual improvement of the Quality System. 

INSTRUCTOR BIOGRAPHY:

Wayner Williams 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 24 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.