Combination Products Regulatory Expectations and the FDA’s Latest Codification of the Applicable cGMP Requirements

Live, Interactive Training Webinar

Date: Wednesday November 6, 2019 - Time: 10:30 AM - 12:30 PM ET
Barry A. Friedman Ph.D. Biography>>>

Member Registration ►

Registration Form ►

Historically, the absence of clear cGMP requirements for Combination Products has resulted in inconsistent application as to the applicable Agency Center to submit product for review. Products for both CDER and CBER as the primary Agency contact point may have historically been submitted to the incorrect organization for review because of a lack of knowledge as to the Primary Mode of Action (PMOA) of the product. While some of these product applications might have been relatively easy to discern, e.g., a pre-filled syringe (usually CDER), other products may have had great difficulty finding the “correct home”. In October 2004, the FDA issued a Draft Guidance for Industry entitled “Current Good Manufacturing Practice for Combination Products”. NINE years later, the FDA has CODIFIED the cGMP requirements applicable to combination products. This NEW rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, biological products and human cell and tissue products (HCT/Ps) are combined to create a combination product. This permits both a client company and the FDA to move the product through the regulatory system most efficiently. The new rules also discuss a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for single-entity and co-packaged combination products.

The objective of this live training webinar is to explore this new rule and guidances for the industry as they apply to your organization and examine options for obtaining compliance within a cGMP framework.

Learning Benefits:
-The latest cGMP Requirements for Combination Products.
-Clarification of the cGMP Requirements that apply to Combination Products.
-Ensuring the Consistent and Appropriate Application of these Requirements.
-Examination of the various Guidances for Industry.
-Determining the Primary Mode of Action (PMOA).
-Learning how to Streamline the Practical Implementation of cGMP Requirements.
-Ensuring that cGMPs for Co-Packaged and Single-Entity Combination Products are Consistent and Appropriate without Duplication.
-Determining what new cGMP Requirements may be required.

Webinar outline and time breakdown:

09:15 AM Log In Period
09:30 AM Introduction
09:40 AM Definitions,
Combination Products – Codification of Rules,
Combination Products – What are they,
Examples of Combination Products,
10:30 AM Break
10:40 AM Products – Primary Mode of Action (PMOA),
Designations, Assignments, and Miscellaneous,
The Guidances for Industry,
Europe – MHRA,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Legal
  • Those that use contract manufacturing and contract testing facilities
  • Auditors

Registration Form ►

Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>



Course Number: 232

System Requirements:

All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.

Live Training Benefits:

• Pharma Webinars training webinars and programs are presented exclusively as live events only.

• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.

• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.

• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.

• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.

• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.

• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.

• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.

• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.

Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland