Course Number: 206

Raw materials and components management. Latest FDA and EMA regulatory requirements including a review of the EMA falsified medicines directive, FDA safety and integrity act, drug supply chain security act , and secure supply chain pilot program.

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Peter Calcott Ph.D. Biography>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

Over the last ten years we have seen the landscape of the supply chain changing. Gone are the days when we only focused on the materials and product in the warehouse. Gone are the days when you could rely on the label on the product. Counterfeit drugs are out there and it’s a growing problem. Even your raw materials and components that you relied upon are no longer assured. Foreign and domestic manufacturers are running afoul of the regulations. You can either wait for disaster to strike, or be proactive and assure it will never happen.

The regulators (FDA and EMA) have taken the bull by the horns and developed guidances, regulations and acts to guide you as you set up your systems. The approach is different but complementary. The progressive company learns from both and develops a strategy to assure that the product they make is assured and arrives in top condition at the patient.

We will cover the elements of assurance of the supply of raw materials and components and how the Europeans have approached it. When you make the product we will focus on how you can be assured that it arrives in the condition intended. This includes assuring the distribution network is secure and meets the product storage conditions. Managing third party manufacturers will be a key point so you can add confidence in your suppliers.

In this live webinar we will walk through all the new regulations and what is contemplated in the future with details on what must be done and when. We will include best practices to investigate and correct issues discovered in your systems.

Learning Benefits:
-Where your supply chain is vulnerable and what to do about.
-What the latest challenges are and what the agencies are expecting you to do.
-The requirements of the EMA Falsified Medicines Directive and when the elements must be implemented.
-The requirements of the FDA Acts that have been recently passed including Food and Drug Administration Safety and Integrity Act (FDAsia), Drug Supply Chain Security Act (DSCSA), & Secure Supply Chain Pilot Program (SSCPP).
-How to prioritize what is the most critical and must be acted upon and what you can postpone.

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM What is the supply Chain and modern Materials Management,
Where are the vulnerable steps,
What is the FDA and Canada proposing,
What do the Europeans want,
Harmonization of the two,
What to focus on,
11:30 AM Break
11:40 AM Building security in your raw materials,
Protecting the bulk substance and drug product in shipment,
Counterfeiting and the internet,
Managing CMOs,
Working with the regulators,
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
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Auditors
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

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"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

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"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