Combination Drug/Device Products cGMPs – Final Rule

This training on combination product regulations will evaluate the chief areas of concern or change in the new cGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products.

There has been much past confusion on the production and handling of drug / device (and/or biologics) combination products. Companies involved in the production of such products have pieced together what they’ve considered the applicable elements of the pharma and device cGMPs, 21 CFR 210/211 and 820; sometimes with ambiguous advice from the agency, resulting in some disagreements during compliance audits.

Do not let yourself or your company be caught off guard by the new cGMP requirements for combination products. Attend this training to enhance your awareness of these new cGMP requirements and modify internal audits to match this FDA shift. This training will be a step-by-step review of the key elements of the U.S. FDA’s new final rule, “Current Good Manufacturing Practice Requirements for Combination Products”, 21 CFR Part 4. The presenter will evaluate and clarify many of the pertinent issues and questions that arise involving combination products.

This session will provide valuable assistance to all regulated companies in evaluating their existing or proposed cGMP compliance and internal audit emphasis for the production of combination products, as a sub-contractor or primary manufacturer. Once you have recognized the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure compliance to the new rule.

Areas Covered in the Session :
The Four Basic Types of Combination Products
Two or more of device, drug, biologic;
Physically combined; or
Packaged together; or
Packaged separately but intended for use only with another, different type of medical product (“cross-labeling”).
The CGMP “Operating System”
Constituent Parts
Applicability of 21 CFR 210/211, 600-680, 820, and 1271
The Two Ways to Compliance
Single-type Constituent Part Facilities
How to Address cGMP “Conflict”

Who Will Benefit:
This training applies to personnel / companies primarily in the pharmaceutical, medical device, and biologics fields. The employees who will benefit include:
Senior management
Regulatory affairs
Quality assurance
All personnel involved in a U.S. FDA-regulated environment; especially those involved in cGMP compliance of affected regulated combination medical products

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

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, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance