Posted in | Qualitative Analysis

The Flexibility of Compliance and What If …? Part 1/2

Webinar Dates
  • Thu December 10, 2020
    8:00 AM GMT 50 minutes
  • Thu December 10, 2020
    4:00 PM GMT 50 minutes
  • Wed May 19, 2021
    8:00 AM GMT 50 minutes
  • Wed May 19, 2021
    4:00 PM GMT 50 minutes
  • Thu November 25, 2021
    8:00 AM GMT 50 minutes
  • Thu November 25, 2021
    4:00 PM GMT 50 minutes

Handling Risks and Errors in Pharma Records - there should be procedures to stay compliant. With their focus on Data Integrity, regulation authorities are ever pushing the pharmaceutical industries towards electronic records. The number of FDA warning letters with citations of data integrity violations reveal that not every pharma company interprets the rules correctly and with an acceptable risk management policy.

Conservative practices might overlook the dynamic of regulations and might end in incompliance just because the interpretation of rules have evolved.

Moderator: Bob McDowall and Christoph Jansen

Duration: ca. 50 minutes

10/12/2020 08:00 [ English ]
10/12/2020 16:00 [ English ]
19/05/2021 08:00 [ English ]
19/05/2021 16:00 [ English ]
25/11/2021 08:00 [ English ]
25/11/2021 16:00 [ English ]

Times are given in your local time. Your current time is 10:31:29 GMT+0000 (Greenwich Mean Time).

To learn more about the ways to interpret Pharma Regulations.

In this Webinar we will discuss with Bob McDowall:

Part 1/2

  • Introduction
  • The flexibility of compliance; Aspects about interpretation of pharma regulations and it's dynamics.
  • What are the risks for paper records today?
  • Critical aspects about USP methods that base on observation.
  • Blank Paper forms and the administrative overhead.
  • How should you assess the cost of compliance versus risk?

The Flexibility of Compliance and What If...? Part 2/2

What are the action items of violations and findings?

  • Unofficial testing
  • What do you recommend in terms of software updates?
  • What is the best time to report issues?
  • Cost of compliance
  • Cost efficient CSV with platform solutions

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