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Last Wednesday (March 12th) we held our webinar related to new and global supply chain regulations and Risk Assessment and Risk Planning. This webinar was well attended and the majority of those individuals that had registered did attend and listened to the webinar.

If you missed this for any reason, or need to listen to any portions again the actual recording is now posted on our website (under resources) at the link below:

In addition to this there were three questions that were submitted during the webinar and I am listing these below with my answers:

1. I have my Risk Mitigation Plan all documented, but how do I know if it’s complete?

Answer: The best way is to conduct audits with independent groups like QA and ask others that work in the area to also step through your Risk Assessment documentation and then review the Risk Mitigation Plan. Also make sure you communicate the plan to those with a need to know because they will always be able to provide feedback if and when problems may occur.

2. How often should we update our Risk Mitigation Plan, or perform a further Risk Assessment, when a new regulation comes along, or on a regular basis?

Answer: The first and obvious time is when new regulations are introduced or you go to a new region where new regulations may apply. As a general rule any time there is any kind of change (new shipping lane, new courier/carrier, different mode of transport, etc.) and if no significant changes have an internal audit every 3 to 6 months dependent upon if issues have been occurring, or based upon the intrinsic value of the products being shipped.

3. How do current regulations address use of temp monitoring devices in every shipment.

Answer: There are a number of global regulations that actually specify that a monitoring device is included with any cold chain shipments - Saudi Arabia and Canada come to mind immediately.

However, by inference the newest regulations specifically require that a record is keep of cold chain products both in the warehouse and during transportation to insure maintenance of suggested temperature control conditions as defined by the manufacturer. The only way to do this is with a cold chain monitoring device or a management application solution, so that a record is available in case you get an audit from a body like the FDA, or a batch of bad drugs is traced back to the suspected responsible party.

For your reference I am giving you below a link to the overview of the Chinese FDA regulations:

If you have any more questions or wish to contact me please do so via email at: This email address is being protected from spambots. You need JavaScript enabled to view it., or directly at: +1 978-302-3472

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Peter Norton is a senior logistics and supply chain manager who is a consultant hired by clients in both the life science industry, and the food supply industry. Peter has extensive experience in both the domestic US and global markets specifically in the areas of cold chain management and security as this relates to the pharmaceutical industry to insure drugs that are supplied to the patient are at the required stability levels and peak efficacy.

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