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COURSE ID 2966

Combination Product Risk Management Principles: An Engineering and QA Perspective | Part 2

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
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ACCREDITATION CEU's - 0.2 IACET
View Course Outline

Managing the complex lifecycle of combination products requires the efficient utilization of resources of a pharma/device company regardless if the company is vertically integrated, utilizes both in-house and contract manufacturing, or is a truly virtual company.

This second of two 90-minute accredited training courses will define and apply recognized risk management principles in developing effective and compliant Quality Agreements, tiered supplier monitoring, CAPA, validation and Change Control systems. It is recommended that participants attend Part I of this course.

The course is appropriate for all operations, quality, development, and project management functional areas but will emphasize the perspective of Engineering and Good Engineering Practices where applicable.

For maximum training benefit, you are encouraged to attend the complete 2-part series.
Combination Product Risk Management Principles: Part 1 (course id #2965)

who should
attend?

LEVEL
Intermediate
INTERESTS
Biotechnology / Biopharmaceutical Medical Devices / Diagnostics Pharmaceutical Science & Technology

This course is intended for professionals involved in the Pharmaceutical, Medical Device, Biopharma and Biologics industries.

Managers, Directors and Specialists working in Engineering, Supply Chain, Manufacturing, Packaging, QA/QC and Project Management will benefit greatly by attending this training.

All operations, quality, development, and project management personnel who are involved in ensuring Good Engineering Practices should attend.

course instructor

Frank Carroll
Director, Supply Chain and Facilities, Zosano Pharma/ZP Group LLC

Frank Carroll’s Courses
Frank Carroll is Director of Supply Chain and Facilities for Zosano Pharma/ZP Group LLC in Fremont CA. He has over 25 years of experience in the Pharmaceutical, Device, Biologics and Biotech industries in many aspects of operations including manufacturing, purchasing, materials management, strategic alliance management, implementation of advanced project management and MRP/ERP systems and senior operations management. He has held senior management positions with Genitope Corp., Alpha Therapeutics, Inamed Corp., Collagen Corp., and Bayer AG. He has earned certifications from APICS (CPIM), ASQ (CQE), and Zenger- Miller as a certified trainer. He has instructed/directed numerous courses for the Center for Professional Advancement, instructed courses for APICS CPIM certification, and was a faculty member at Indiana University at South Bend in Continuing Education programs. He received his B.Sc. from The Ohio State University and MBA and MSBA degrees from Indiana University.

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