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Overview:
Data integrity and good documentation practices (GDP) are essential in providing evidence of a safe and effective product. Learn what the key elements of good documentation practices and data integrity are, how to apply them, and how to proactively ensure your system is compliant.

By the end of the course, participants will be able to:

  • Describe FDA Regulations for Good Documentation Practices (GDP)
  • Perform GDP
  • Describe FDA Guidance for Data Integrity
  • Apply Data Integrity
  • Apply Risk Management, Investigation, and CAPA to Data Integrity Concerns

Who Should Attend:
Anyone who works in a regulated industry

Prerequisites:
No prerequisites required. Overview of FDA Regulations and Quality Systems Overview or relevant experience are highly recommended.

Cost: Half-day class

Location: Oregon Bio Virtual Classroom

Tickets

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Data Integrity - Member
Employees of Oregon Bioscience Association member companies receive discounts on BioPro classes. Visit the Membership Directory for a list of current member companies.
$ 200.00
19 available
Data Integrity - Non Member
$ 250.00
19 available

Details

Date:
October 26
Time:
8:00 am - 12:30 pm
Cost:
$200.00 – $250.00
Event Categories:
,

Organizer

Oregon Bioscience Association
Phone:
(503) 548-4432
Website:
https://www.oregonbio.org/

Venue

Oregon Bio Virtual Classroom
OR United States + Google Map
Phone:
503-953-3145