Supply Chain Security – A Comprehensive Examination of the Latest Technical Challenges from Procurement of Raw Materials to Distribution of Drug Products & Latest FDA, Canada & EU Regulatory Requirements

Live, Interactive Training Webinar

Date: Wednesday January 22, 2020
Time: 10:30am - 12:30pm ET (New York Time)
Instructor: Peter Calcott Ph.D. Biography>>>

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This exclusive live training webinar is designed to provide both technical and regulatory requirements as you design and implement your supply chain from procurement of raw materials to the distribution of your products to the customers. Things are changing in the market place. Products are becoming more complex and vulnerable to degradation if not handled appropriately leading to the need for careful consideration on the route and method of distribution as well as the appropriate safeguards such as cold chain. Regulators are recognizing that the product when it leaves your controls is vulnerable to unscrupulous interference and have issued new regulations to combat these challenges. In this webinar we will cover both the strategy and the science for what to do to protect your product as well as an interpretation of what the regulations are advising us with a view to the direction they are headed in the future in the USA, EU and Canada.

This live training webinar focuses on the new sets of regulations emanating from the EMA, Canada and the USA. These include the Falsified Medicines Directive from the EMA and Guidance for counterfeit drugs from Canada as well as the FDAs : Drug Supply Chain Security Act (DSCSA) and FDA Security and Innovations Act (FDAsia). All three agencies recognize the problems as they exist out there but have approached the problem in different manners at different speeds. This has led to confusion as well as disjointed approaches to secure the supply chain. This webinar will spur you to examine how you can implement features of these regulations to maximize your security but stay ahead of the requirements in a cost effective manner without going too far. This will put you ahead of the curve building a stronger, more robust supply chain before the US and Canada catches up.

This Live Presentation Will Cover:

- The supply chain and its risks in the context of the new EU Directive, Canadian Guidance and the US guidances
- How to use modern Quality Risk Management to identify, analyze, prioritize risk and develop remediation to address the risk to the supply chain
- The effect of the elements including assuring Active Pharmaceutical Ingredients and Excipients security and quality
- Some of the recommendations for assuring authenticity of drugs in the market place including identifiers on packs, in on-line commerce and the increased oversight of drug brokers and repackagers
- How much further the EU is ahead of the US and Canada in the process of the distribution chain on the finished drug product and measures to assure security in the supply chain

Learning Benefits:

- How to examine your supply chain and with the use of Quality Risk Management identify where risk is present at unacceptable levels.
- How to develop a remediation plan to decrease risk to an acceptable level in your supply chain.
- The driving forces (the where and why) behind the European desire for supply chain security with the Falsified Medicines Directive and the US guidance for identification of counterfeit products.
- How to work with your suppliers of API and Excipients to strengthen the security of the supply chain at the front end.
- How to develop a stronger relationship with your distributors and drug brokers to increase security at the back end.
- How to be proactive in areas the FDA is silent by learning from the Europeans and being ahead of the game.

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Recognizing the driving force in Europe for change,,
What does the EU Falsified Medicines Directive say?,
What it means for the EU market and how it affects other markets,
Mapping your supply chain,
Determining risk in the supply chain using ICH Q9,
11:30 AM Break
11:40 AM Active pharmaceutical ingredient assurances,
Strengthening the Excipient supply,
Distribution chain weaknesses,
TBuilding safeguards in the product for rapid identification and assurance,
How it applies in the US and Canada,
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
• Reference to all applicable Guidances both in the US and EU as well as Canada
• FDA Security and Innovation Act (FDAsia)
• Drug Supply Chain Security Act (DSCSA)
• Falsified Medicines Directive
• Guidance for Counterfeit Drugs

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

    • Logistics and procurement management
    • Quality Assurance personnel
    • Auditors
    • Quality Control personnel
    • Project Managers in the CMC area
    • Manufacturing Managers
    • Regulatory Affairs Professionals

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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>>>



Course Number: 308

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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