5-hr Virtual Seminar: GMP Requirements for Combination Products for the Medical Products Industry

Why Should You Attend:

Are you or your company confused about the requirements for combination products? Questions such as "Do I need 2 GMP systems?" or "Can the master record be a “hybrid master record?". The FDA has published a draft guidance, “Guidance for Industry and FDA - Current Good Manufacturing Practice for Combination Products (Draft Guidance) which helps explain much of the regulatory thinking. However, it fails to provide the necessary detail needed to develop confidence in the system that will ensure all customer requirements are met.

This course will address complexities in combination products (regulatory, business and quality processes) and break them down into their simple elements. Then these elements will be rebuilt into a practical system that will enhance understanding of the requirements. This understanding of requirements will provide you with the tools you need for developing or revamping your quality system to meet this new paradigm. This will result in a smoother development and approval for your product as well as prevent any "big showstoppers" that delay or threaten your project.

Learning Objectives:

• Combination products, as its name implies, is to FDA regulated products which have different modes of action, in the diagnosis and treatment of disease. The most complex frequent is the drug & device combination.
• Provide an understanding of the differences within the various types of combination products.
• More similarities than differences exist between the GMP's for Drugs and Devices. Principles of all quality systems are the same.
• Only one quality system   is required to control manufacturing, testing of combination products.
• Quality Systems for medical devices are more quality system orientated than drug GMP's but the drug GMP's are now advancing.
• The lifecycle differences between drugs and devices impact their approval and  regulation.
• Staffing for combination products is much more complex than single products.
• The FDA's draft GMP guidance will be incorporated as applicable. This course is designed to better show specific similarities and differences between manufacturing single and combination products.

Areas Covered in the Seminar:(All time in EST)

Handouts:

PDFs of the following will be provided

• Diagrams explaining the subject matter.
• Process Diagrams.
• Relevant & Applicable FDA Regulations & Guidances.

Who Will Benefit:

The following personnel in drug and device manufacturing companies will benefit:

• QA/ QC Managers and personnel
• Regulatory Affairs
• Product Management
• Supervisors & Group Leaders
• Production Management
• Purchasing
• Warehousing

Instructor Profile:

Howard Cooper, has over 35 years experience in the pharmaceutical and medical device industry creating, implementing, managing & remediating quality systems. This experience has shown his leadership, organizing & problem-solving skills to develop quality systems from scratch or in the role of a change agent to remediate failing systems. This experience includes small and large companies operating in the US, Europe and Japan. He has worked with a wide variety of FDA regulated products such as medical devices, in vitro diagnostic reagents and instruments, in vivo diagnostics, pharmaceuticals (Tablets, capsules, injectables), biologicals, monoclonal antibodies), and combination products.

He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

During experience described above, Mr. Cooper has implemented full supplier qualification systems and programs. This includes both consulting and employee roles.

Topic Background:

As you know, medical diagnosis, technology, and treatment is very dynamic and is rapidly advancing. New discoveries are made that do not fit the "regulatory mold “and thus require new approaches to regulation. Combination products is one such area that has grown proportionally as technology advances creating in the need to rethink the processes for classification, design, quality assurance, and regulatory approval of such products. This challenges industry and the FDA to develop strategies for effectively working together to meet user and customer needs. As a professional, you are aware of the complexities of also combining the regulatory, business, and quality processes to make such products a reality.

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