Course Number: 202

Quality Management System (QMS) – The New QMS Paradigm Explained - Comparing Commonalities Between FDA, EMA and Other International Regulatory Requirements

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Kim Huynh-Ba Biography>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

This live training webinar will focus on the significant changes that the FDA, EMA, Japanese authorities and other countries have been driving over the last decade. All agencies have recognized we have been driving our operations to the mantra of what does the agency want? We have become an industry that is more interested in “check the box of compliance.” Now the agencies have told us what they want. They want us to be data and science driven. They want us to tell them what we will do and show them why it is the right thing to do. We are at a crossroads of taking back our industry and controlling our own destiny again.

In this live presentation, we are going to focus on the building blocks that you will need in place. Some of them are in the Guidances already while others are on the way. Some of them may be implemented in your operations but not all, I hasten to say.

ICH Q7 – GMP for Active Pharmaceutical Ingredients is the cornerstone of the concerted GMPs accepted worldwide. This is augmented by ICH Q10 – Pharmaceutical Quality Systems. This is based on ISO 9000 and includes a drive for continuous improvement (CI) which is built on science based and data driven decisions. Included is the active participation of management in driving for improvements not only to our products and processes but also our QMS. A key cornerstone of CI is an effective Corrective Action and Preventive Action (CAPA) process.

This science driven and fact based decision making cannot be successful without considering the lifecycle of the product and process. ICH Q8 (Pharmaceutical Development) and Q11 (Development and Manufacture of Drug Substances) deal with the modern approaches to development of products and processes. In order to arrive at a product that is patient focused and a process that yields the product consistently, we have to be ruthless in the development cycle and only focus on high value added work. The tools of Quality Rick Management (ICH Q9) are critical to differentiate the relevant from the irrelevant in process design. The management of the lifecycle activity is beginning to take shape with the latest ICH Q12 - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The concept paper is out and the first draft will follow soon.

Certain other systems are critical in this new QMS paradigm. Change control becomes a critical element of the development cycle, so the system must be fast and nimble in development versus the stolid ponderous of commercial. The internal self-inspection program that most view as a check to assure everything is in compliance can take a new role as a source for CI looking for improvements and proposing best practices they have seen elsewhere. The Annual Product Review blossoms into a CI tool, where trending and interpretation lead to improvements.

Learning Benefits:
-How all of the agencies are approaching the new QMS requirements, what they expect and what they will be inspecting you for.
-How GMP and ICH Q10 are linked and how ICH Q9 ties into the new system requirements.
-How lifecycle management for products and processes and your QMS are tied together through Knowledge Management.
-How to evaluate and revamp you systems to meet the agency expectations and also streamline your operations.
-Learn what the new ICH Q12 may very well say and how you can be ahead of the game.
-Management’s increased role can aid in your long range and day to day operational efficiency.

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM The new QMS paradigm and what it contains,
ICH Q10 and its implementation,
Tying ICH Q9 into the operations,
Product Life cycle and what it entails,
Knowledge management – its value,
11:30 AM Break
11:40 AM Systems as they evolve over the life cycle,
Fueling the continuous improvement process,
Key role of an effective CAPA process – how to make it serve you,
Self-Inspection and APR in a new light,
The new ICH Q12 – Product Lifecycle,
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
Schedule & Deliver this Live Training Webinar Privately to Your Group

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>>>



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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