Cold Chain Management - The Latest Regulatory Requirements for Product Distribution in the USA, Canada, and the EU; Detailed Analysis of the EU GDP Guidance

Live, Interactive Training Webinar

Date: Thursday August 22, 2019
Time: 10:30am - 12:30pm ET (New York Time)
Instructor: Peter Calcott Ph.D. Biography>>>

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Product distribution has been around as long as we have been making drugs for sale to customers. 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 training webinar will provide valuable information on the requirements for product distribution as defined by the regulations in USA, Canada and the EU as the agencies reinterpret them and begin to more strongly enforce them. It will also include a detailed analysis of the 2013 EU GDP Guidance recently enacted. We will discuss the absence of guidances in the US which solely relies on a simple chapter in USP. This will enable you to see how successful companies can translate these requirements and changing agency stance into workable processes that are compliant with the regulations and yet efficient from a business perspective, meeting their customer needs. We will show you 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. We will present criteria you can use to assure you validate where appropriate and monitor where necessary. You will be able to benchmark your processes against those of successful companies so you can easily make improvements. You will also see how companies run foul 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 can not 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 minimize risk.
-Where companies go wrong and get into regulatory hot water and how to avoid it yourself.

Regulations that will be Covered:
Each country has its own specific sets of regulations. Below are citations from ICH and examples of regulations that are applicable to the inspection and response processes and philosophy:
Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA.
EMA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU.
International Conference on Harmonisation Quality Series Q1 through Q10 for USA, EU, Japan and other countries with an emphasis on ICH Q7a.

Webinar outline and time breakdown:

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)

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
  • Manufacturing management and scientists
  • Senior Management
  • Regulatory Affairs Professionals
  • Logistics and Procurement Management
  • Project Managers working in the CMC arena

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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: 311

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