Short Course: How Much is Enough? Best Practices and Principles for the Non-Lead Constituent Part Within a Regulatory Submission for a Combination Product
- Medical Device and Combination Products QMS Expert
- Independant Consultant, United States
Mrs. Archer Woodard delivers expertise in the creation, implementation and management of Quality Management Systems for Medical Devices, SaMD, and Combination products. She has more than 20 years of experience that includes building cGMP and ISO quality management systems from the ground up in these areas. Mrs. Archer Woodard has lead Global assessments of Quality Management Systems with expertise in creation of global corporate policies and led projects on combination product harmonization of drug and medical device development, medical device design control, and design history file remediation. Mrs. Archer Woodard has ASQ Certifications in Biomedical Auditing, Quality Engineering and Software Quality Engineering.
Darin Seth Oppenheimer, DrSc
- Executive Director, Device & Digital Health Solutions
- Merck & Co., Inc., United States
Dr. Darin Oppenheimer is an Executive Director of the Drug Device Center of Excellence focusing on Medical Devices and Combination products at Merck. After spending 15 years working in Regulatory Affairs and Development for various organizations within the Medical Device and Pharmaceutical industry, Darin knows how to strategically maneuver the regulated industry to develop and bring products to market.