Topic: Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 R2 Addendum
Date: October 9, 2018
Time: 1:00 p.m. – 2:30 p.m. EDT
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session and recorded (available for 30 days)
Good documentation practices are essential for a quality trial. ICH E6(R2) Addendum clarifies definitions related to good documentation practices. Two descriptions of note are: 1) What represents quality documentation of subject source and regulatory documents; and 2) What constitutes a certified copy.
Join our own Sandra “SAM” Sather for this interactive training session on the essentials of good documentation practices post ICH E6 (R2) addendum. Learn how the recent changes to GCP affect your quality documentation practices and how to ensure you are following ALCOA-C.
Key take away benefits:
Determine if your documentation practices are adequate through a checklist.
Practice using ALCOA-C with paper and electronic documents.
Learn how to prepare documents in case of audit or inspection.
Recognize documentation deficiencies and strategies to address them.
- The Clinical Pathways Team
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