2011 Combination Products Workshop – P1- Introduction to Combination Product cGMPs

Web Code: ComboP1-11
Member/Nonmember Price: $75

Seminar Summary

This seminar will provide an introduction and overview to combination product cGMPs. Challenges and expectations from industry and regulatory will be provided.

Who Should Attend

Department Operations | Regulatory Affairs | Clinical Affairs | Manufacturing | Quality| Product and Process Development Engineering | Project Management

Job Function
Individuals, at all levels, working in strategic roles in quality, regulatory, clinical and manufacturing departments in drug, biologic or medical device companies engaged in the development and manufacture of combination products

Presenters Bio

Michael Gross, PhD, Senior Consultant, Biologics Consulting Group

Michael Gross, Ph.D., RAC is a Senior Consultant with Biologics Consulting Group where he specializes in quality, regulatory affairs and development strategy for drugs, biologics, medical devices and combination products. Dr. Gross has worked in the medical products industry for thirty years in senior quality and regulatory affairs roles. Michael was a research chemist at FDA and regulated and inspected biological product manufacturers. He later joined the medical products industry working for a number of large and small pharmaceutical and biotech companies and a large medical device manufacturer. He is experienced in a variety of therapeutic areas (i.e., cardiovascular, neurological, pulmonary, urology, oncology, ophthalmology, dermatology, anti-infective drugs and blood products) and has written and/or managed the submission of investigational exemption applications [IND, IDE], marketing applications [NDA, 505(b)(2) NDA, sNDA, ANDA, BLA], device registrations [510(k), PMA], and other FDA regulatory submissions [RFD, DMF, BMF, MAF].

Lisa Hornback, Principal Consultant, Hornback Consulting, LLC.

Lisa Hornback, Principal Consultant of Hornback Consulting, LLC, has over 15 years experience regarding interpretation and implementation of FDA regulatory requirements for pharma, devices, and biologics.  For 9 years, Lisa has been a Compliance Consultant, where she has provided expertise and assistance to FDA regulated industry in the US and overseas in resolving FDA compliance issues.  Lisa has designed and implemented quality system solutions, guided companies through resolution of FDA Warning Letters and Consent Decrees, audited operations for compliance to FDA and ISO requirements, and provided training on a variety of technical and regulatory topics.

Prior to entering the world of consulting, Lisa was an FDA Field Investigator and the FDA’s Midwest Regional Medical Device Expert.  In this role, Lisa was responsible for compliance inspections of highly complex pharma, device, and biologic industries and obtained extensive experience in FDA’s approach to initiation and resolution of Warning Letters, Consent Decrees, and product seizures.

Lisa obtained a Bachelor of Science in Medical Technology and has worked extensively in the hospital setting, which has provided her with the end-user perspective on the products regulated by FDA.

Angela Krueger, Product Jurisdiction Officer, CDRH, FDA

Angela Krueger is a regulatory advisor in the Office of Device Evaluation (ODE) at the Food and Drug Administration (FDA) and is also the Product Jurisdiction Officer for the Center for Devices and Radiological Health (CDRH). Angela came to the Agency in 2003 with a Bachelor of Science Degree in Chemistry from Butler University, and a minor in journalism. In her current position, Angela is involved in a range of regulatory and scientific issues and decisions in ODE, including policy, guidance and regulations development. As the Product Jurisdiction Officer for CDRH, Angela is the Center’s liaison to the Office of Combination Products and oversees a broad range of combination product issues in CDRH. Angela previously worked as a scientific reviewer in the Division of Cardiovascular Devices, ODE, leading the reviews of pre-IDE, IDE, 510(k) and PMA submissions for a wide variety of devices, including inferior vena cava (IVC) filters, iliac stents, arterio-venous (AV) access surgical and endovascular grafts for dialysis patients, and drug-eluting stents and balloons.

Registration contact

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org