Quality Management System (QMS) – The New FDA, EU and Global Regulatory Requirements, Maintaining the Validated State and Driving for Consistency

Live, Interactive Training Webinar

Date: Tuesday March 12, 2019 - Time: 9:30 AM - 11:30 AM (Eastern New York Time)
Instructor: Peter Calcott Ph.D. Biography>>>

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This live training webinar focus on the building blocks of the Quality Management System (QMS). Those building blocks are to assure that operations are in control and maintained in their validated state. It involves systems of checks and balances, methods of measurement to detect disturbances and systems to assure that changes introduced deliver improvements or are at least neutral in their effects. All of this is to assure that the products made are what was developed and promised to the regulatory bodies and what is best for the patient. The philosophy is that quality must be built in rather than tested in.

We will describe the building blocks that you will need in place which are described in ICH Q7 – GMPs for Active Pharmaceutical Ingredients and ICH Q10 – Pharmaceutical Quality Systems, which is based in ISO 9000. These include the overall Quality Philosophy defined in Quality Manuals, Quality Polices and Quality Planning; it includes the Document Management System, Personnel Learning and Development and the role Management plays in setting the culture to assure it is executed.

In a modern QMS, decisions are science and data driven with risk-based approaches (ICH Q9 – Quality Risk Management) incorporated. This entails controls over facilities and equipment, production controls, product assessments and controls, and materials controls.

Internal audits, self-inspections, quality metrics and annual product reviews are tools to assess how well we are doing versus our goals, which will allow course corrections to be made with continuous management assessment and actions. The change control system plays a pivotal role in assuring that all changes contemplated are both value added and appropriate as well as managed well to lead to success which ultimately is to focus on the patient.

Learning Benefits:
-Why we have a QMS to assure we build quality in rather than test in.
-How all of the agencies are approaching the new QMS requirements, what they expect and what they will be inspecting you for.
-How GMP regulations plus ICH Q7 and ICH Q10 are linked and how ICH Q9 ties into the new system requirements.
-How to evaluate and revamp your systems to meet the agency expectations and also streamline your operations.
-How to bring back science and data based thinking into the design and operation of your systems.
-How important an efficient change control system is in your operations.
-What systems are important to assure you maintain your validated state.
-Management’s increased role can aid in your long range and day to day operational efficiency.

Webinar outline and time breakdown:

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM What is a QMS and how it is important,
Overarching Philosophy of Quality,
Have the agencies changed direction?
The basic building blocks of a QMS,
People, policies, procedures and paper,
10:30 AM Break
10:40 AM Facilities, process and product control,
How to measure performance success – the tools,
The key role of change control,
What are the signs things are not going right?
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 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
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Auditors
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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