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

A Comprehensive 2-Part Live Webinar Training Program

Instructor: Peter Calcott Ph.D. Biography>>>

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This exclusive two part live training program 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 two part 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.

Please scroll down for complete details of both parts of this exclusive live training program.

Part 1 - Supply Chain Security – Understanding the Latest FDA, Canada and EU Regulatory Requirements

Live, Interactive Training Webinar
Date: Wednesday May 29, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

The first live webinar focuses on the nature of the distribution channels we use. It is the final step in the supply chain, often out of our immediate control. And as such, it is a weak link in the process. With the introduction of more labile and complex products, we are presented with medicines that must be protected from the environment and degradation. These new medicines often require low temperature storage and transport and hence the term Cold Chain Management was employed. To assure that these medicines stay in these strict requirement ranges takes complex controls and processes. Some can be validated to assure consistency while others by their nature cannot but rely on monitoring to assure compliance.

This Live Presentation Will Cover (Part 1):
- Requirements for product distribution as defined by the regulations in USA, Canada and the EU
- Detailed analysis of the EU GDP Guidance
- How successful companies can translate these requirements and changing agency stance into workable processes
- Simple ways to assess from a risk perspective the steps in the distribution chain to identify your weak links and also areas where you are overdoing controls
- Criteria you can use to assure you validate where appropriate and monitor where necessary
- Benchmark your processes against those of successful companies so you can easily make improvements
- How companies run afoul of the agencies new interpretations resulting in warning letters and how from this information you will be able to assure that you do not suffer the same fate

Learning Benefits:
- How the supply chain links to distribution and where cold chain management is essential.
- What components are the most vulnerable and how to remedy.
- What steps can and cannot be validated.
- When to monitor your product and when validation is sufficient.
- Why clinical trial material distribution is more risky than commercial.
- What the new European regulations are saying and how it can help you.
- How your stability groups can help you minimise risk.
- Where companies go wrong and get into regulatory hot water and how to avoid it yourself.

Webinar outline and time breakdown:
Date: Wednesday May 29, 2019

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM How Distribution fits into the Supply Chain and why it is a weak link,
The regulations governing and controlling Product Distribution - GDP,
The new EU Guidance on GDP and what it means,
How to manage the contractor of this service,
Room temperature versus cold chain distribution - the challenges,
11:30 AM Break
11:40 AM Steps in the process - risk analysis,
How to protect your product,
Monitoring versus validation,
Stability program and how it helps distribution assurance,
Challenges specific to clinical trial material distribution,
Where companies go wrong and how to avoid their problems,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

Part 2 - Supply Chain Security – How the EU, Canada and USA Approach the Requirements to Protect Our Products and the Direction it is Heading

Live, Interactive Training Webinar
Date: Wednesday June 5, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

The second session of this live training program 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 (Part 2):
- 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:

Date: Wednesday June 5, 2019

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,
Building 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 program 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 training program:

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

Click Here to Register for this Live Training Program

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