PDA Software Supplier Audit Program

The PDA (Parenteral Drug Association) has released Technical Report 32: Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations. PDA has an agreement with an “audit repository” for making software vendor audits available to companies, thus reducing the need for duplicate audits from various companies. Although done for the Drug Industry medical device companies may also find these reports of value.
For more information click on the link provided. Thanks to David Manalan of INQC for this information.

SoftwareCPR keywords: COTS, OTSS, Vendor

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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