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Food Safety Modernization Act (FSMA)

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Posted 15 October 2017 - 07:38 PM

Food Safety Modernization Act (FSMA)
Start Time: 3.30 p.m. London, 10.30 a.m. New York
Carlos Romero, President/Owner, QSPS Consulting LLC
FSMA Compliance. What is being observed to date in the industry in regards to enforcement . Challenging of  the HARPC Plans and Preventive Controls . How the PCQI should best position  themselves to be fully compliant with the requirements. Foreign Supplier Verification and can your broker become a weak link in your supply chain. Transporation and are we doing a good enough job to mantain clean trailers and containers.

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Posted 20 November 2017 - 10:07 PM

Will you discuss the FSVP (Foreign Supplier Verification Program) and what are the rules if I am an importer or only the Manufacturer buying from an importer?

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Posted 20 November 2017 - 10:55 PM

Our customers and potential customers are setting up their supplier approval & pre-approval process and many are asking for our suppliers risk based analysis food safety plan.

Our suppliers are concerned that by sending the plan to everyone requesting it, they are  giving out a "road map' to their process and potentially putting their products/company/end users at risk by showing where they could be vulnerable in turn potentially violating rule 7 -  Mitigation Strategies to Protect Food Against Intentional Adulteration.


Is there another option other than the 3rd party audit specific to FSMA that has not yet been finalized?


Can our suppliers refuse to send it to any one other than FDA?

Guest_Laura E_*
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Posted 21 November 2017 - 04:09 PM

As a QA Specialist responsible for qualifying domestic/foreign suppliers - What credentials or experience should one have to be successful in this role? 


Also, in your view, what is a good way to make sure you obtain all the certifications/documentation needed to qualify both small/large overseas vendors shipping products going into OTC's, dietary supplements?  


Other than DEA registration certificates, what other documents are important to the DEA or FDA  when it comes to qualifying suppliers of controlled substances and List I type chemicals going into finished products?


Thank you for the session on FSMA-it was very informative.  

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