Drug, Device and Combination Product Development

Description:

This webinar will address the basic steps to take an R&D product and develop it into a commercial product that meets market needs while satisfying regulatory / documentation requirements. What are the US FDA's expectations for the product and its production line under the CGMPs, its equipment, tests, personnel, material control, use of P&PC (production and process controls), including statistical techniques, justifications for product acceptance or validation and other studies, and the critical documentation requirements? Subject areas considered are: Basic CGMP requirements, setting up the production line, Implementing the CGMPs; Documentation; Training; Validation of Process / Equipment required files and other documentation.

Why Should You Attend:

How does a project leader / manufacturing engineer / QA / manufacturing supervisor and similar personnel tasked with taking an R&D project and make it commercial? Finalizing the formulations or design, and then setting up a new or changed production line - designing, scaling-up, and documenting a compliant operation satisfying regulatory, product, and business requirements? And, since medical products are subject to risk, how is comprehensive medical device testing throughout the entire product life cycle established and managed. Such critical steps in the transformation process from an innovative design into a reliable and marketable product are a major concern. How addressed? How to perform Verification and Validation and maintain the production system in a state of validated and statistical control using various Product and Process Controls required of the CGMPs to monitor and control a process. These CGMP required systems ensure that the process operates efficiently, producing more products conforming to specifications.

Areas Covered in the Webinar:

• From R&D to the Production Floor
• Initial steps in establishing the system: Operations and Documentation
• Basic systems in the CGMPs
• Special requirements for Drugs, Devices, Combination Products
• Labeling and packaging considerations and testing.
• Monitoring / control of equipment / systems
• Verifications and/or Validations
• Required files / documentation / records
• Regulatory involvement
• Scale-up

Who Will Benefit:

• Senior management in Devices, Pharma, Combination Products
• QA / RA
• Medical products V&V teams
• R&D
• Production
• Engineering
• Operations
• Marketing
• Consultants; others tasked with medical product development, manufacturing, process / product / data analysis, and V&V responsibilities

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 43 years experience in U.S. FDA-regulated industries, 18 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, 6 chapters in the two RAPS validation text books, conducted workshops and webinars worldwide on US FDA regulatory issues. John is a graduate of UCLA.

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