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>>>
Date: Wednesday January 22, 2020
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
- 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:Time*
|10:15 AM||Log In Period|
|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,|
|11:40 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
• Quality Control personnel
• Project Managers in the CMC area
• Manufacturing Managers
• Regulatory Affairs Professionals
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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