Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices.
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on Good Documentation Practices for GMP Operations Date: Tuesday, March 19, 2013 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Location: Online Instructor: Kerry Paul Potter Course "Good Documentation Practices for GMP Operations" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a Register Now participant's RAC recertification upon full completion. Overview: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices. According to the FDA, if it isn't written down, it didn't happen. As well, if it isn't written down clearly, it didn't happen either. GMP compliance (21CFR, Part 211) requires the use of good documentation practices. Areas covered in the session: l 21CFR Part 211 and Eudralex references to documentation l Correcting errors and omissions l Dates and formats l Meanings of initials and signatures l Use of "NA" l Comments and explanations l Handling raw data (charts, strips, printouts) l Blanks l Entering numerical data Who Will Benefit: About Speaker Kerry Paul Potter l Production personnel President, Summit Consulting, Inc. (operators, supervisors) Kerry gained his pharmaceutical l Laboratory personnel manufacturing experience during his 28-year career with Merck. His career (chemists, technicians, spanned the areas of Quality supervisors) Operations, Audits & Inspections, l Batch record reviewers Laboratory, Human Resources, and l QA Auditors of Production Learning & Development. More specifically, his responsibilities and Laboratory Documents included quality management of l Validation, Engineering laboratory assessment, site GMP lead l Maintenance personnel auditor, FDA QSIT/Quality Management System manager, 5S (mechanics, supervisors) coordinator, GMP trainer (annual, l Warehousing personnel ongoing, new hire), ...more Click here to register for this webinar Suggest a Topic More Webinars GlobalCompliancePanel www.globalcompliancepanel.com 43337 Livermore Common, Fremont CA 94539, USA. Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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