Book Online Tickets for Production and Process Controls - Ensuri, Palo Alto.  This presentation will cover the FDA regulations (21 CFR Subpart G Section 820.70) regarding production and process controls and how each requirement listed within the regulation can be addressed. We’ll go over examples of documentation y

Production and Process Controls - Ensuring your medical device conforms to its specifications

 

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About The Event

 This presentation will cover the FDA regulations (21 CFR Subpart G Section 820.70) regarding production and process controls and how each requirement listed within the regulation can be addressed. We’ll go over examples of documentation you can use to fulfill the requirements of this section, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. We will also go over some additional tips and tricks on how to convey the importance of maintaining production and process control within your organization and ensure resources are provided to meet process needs. At the end of the presentation, I will answer any questions or concerns you may have regarding FDA requirements.

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