Loading Events
  • This event has passed.

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

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
Tickets are no longer available

Details

Date:
August 13
Time:
8:00 am - 12:00 pm
Cost:
$200 – $250
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