Combination Drug/Device Products cGMPs – Final Rule

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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 to be Covered:

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

Carolyn Troiano

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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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