Meeting the Latest Regulatory GMP Requirements During Clinical Manufacturing, Understanding Key Differences in Implementing GMPs in Clinical vs. Commercial Manufacturing

Live, Interactive Training Webinar

Date: Thursday March 19, 2020
Time: 10:30am - 12:30pm ET (New York Time)
Instructor: Peter Calcott Ph.D. Biography>>>

Member Registration ►

Registration Form ►

While operating your commercial manufacturing according the GMP's can be difficult, adhering to the regulations during manufacture of materials destined for clinical trials poses even more challenges. Unlike commercial operations where operations are well defined and processes are validated, clinical manufacturing processes are in a constant flux. In the same way your testing is also evolving as the knowledge of your product and processes increases. How can we maintain GMP's in this evolving world of constant change? It is a challenge that many companies face and have difficulty with. It requires the manufacturing organisation to retain flexibility and agility of operation, but it requires more from the Quality organisation. These staff must retain appropriate levels of control where needed, yet exhibit flexibility when required. Does that mean that GMP's do not apply or we administer GMP-lite? No. Rather we tailor the GMP's to meet the challenges of the special circumstances of the operations. In some cases, we allow great flexibility and in others we enforce tighter controls. Because everything is in flux, we can not build quality into operations and must rely on testing quality in - a cardinal sin in commercial operations. In clinical manufacturing the overall target is to protect the patient in a world of absence of concrete knowledge, especially when not knowing if the product even works.

This live training webinar will provide valuable information designed to prepare you to implement the GMPs differently in the clinical manufacturing setting versus commercial. We will outline the changing world of the operations, as products undergo development and definition, as the stability program evolves and as we set formulations, presentations and expiry dating. All of this while you adjust the GMP's to meet your needs and not losing sight of the goal to protect the patient. It will describe how you judge product quality and acceptability when your knowledge of the product and process is rudimentary and every changing. We will discuss the time when elements must be locked down to assure success in development whilst protecting the patient and assuring success when the product dossier is filed for approval. It will describe tools to help you to make decisions that will be defendable to the company and to the regulators.

Learning Benefits:
-The ever changing environment of clinical manufacturing and how to interpret the GMP's to your advantage.
-Where flexibility is acceptable and required and where it is unacceptable.
-How to make quality decisions where knowledge is absent or sketchy at best.
-How to build the case for your decisions based on risk analysis.
-When various components of your product and processes have to be locked down to maximise your chances of approval.
-How to interpret the regulations which were designed for commercial operations in a clinical world.
-Where GMP rules are broken and it is acceptable.
-How other companies fail to meet the agency requirements in their operations so you do not have to repeat them.

Regulations that will be Covered:
Each country has its own specific sets of regulations. Below are citations from ICH and examples of regulations that are applicable to the inspection and response processes and philosophy:
Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA.
EMA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU, including Annex 13.
International Conference on Harmonisation Quality Series Q1 through Q11 for USA, EU, Japan and other countries with an emphasis on ICH.

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Why are clinical manufacturing operations different from commercial,
What the regulators say about clinical manufacturing,
Working in an evolving landscape,
How to apply GMP's in this world,
Breaking the GMP rules and why it is ok,
Protecting the patient,
11:30 AM Break
11:40 AM How processes and products evolve,
How testing and specifications change,
Establishing an expiry date in an evolving world,
Locking down the product and process,
Transitioning from development into commercial world,
Where do companies go wrong so you do not have to,
12:30 PM 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 participation for attendee training records

Who should attend:

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

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Supply Chain and Logistics Managers
  • Regulatory Affairs Professionals
  • Process Development Scientists and Management
  • Manufacturing Management and Scientists
  • Project Managers working in the CMC arena

Registration Form ►

Instructor: Peter Calcott Ph.D.

Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>



Course Number: 306

This live training webinar will provide valuable information to help trainees have a clear understanding of the various differences for implementing GMPs in the clinical manufacturing setting versus commercial manufacturing.

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