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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: Location and driving directions will be emailed separately upon registration.

Tickets

Details

Date:
June 1, 2017
Time:
1:00 pm - 5:00 pm
Cost:
$50
Event Categories:
,

Organizer

Julie Black
Phone:
503-548-4432

Venue

RAIN, 942 Olive St., Eugene, OR 97401
RAIN, 942 Olive St.
Eugene, 97401 United States
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