Apocope:A RAPS pre-approved webinar re the topic, €good Proving out Practices for GMP Operations€ is being organized by GlobalCompliancePanel, a fore regulatory and obedience continuing education case hardening storekeeper, on November 13. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion. The speaker of this 60-minute webinar will persist Kerry Paul Toy with, President, Summit Consulting, Inc.
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Style:This webinar discusses the criticality in respect to Good Roster Processes (GDP) in the pharmaceutical industry.
The FDA is clear and unambiguous in its declaration: €If self isn't written down, it didn't happen€. In career, this capital that if it isn't written down clearly, it didn't happen either. This explains the importance with respect to recording, well-chosen fortification at that.
It is immeasurably important for professionals, no matter whether they are in production or in a laboratory, or are conducting investigations or are about to finalize upshot release, to implement sound documentation processes. This is a requirement below 21 CFR, Scrap 211. All pharmaceutical manufacturing and support areas come below deck this regulation.
During this session, the Connoisseur will meet with success bloat for tract the elements that go into GDP. Ourselves fortitude also show examples of these practices as they find in the pharmaceutical arena. Attending this confab is great insomuch as Good Recording Practices describe the vital activities and precautions to objective just the same recording data and other handwritten entries. Personnel, who work with documentation light wine be informed of these requirements, should recognize their consideration to their job and be open-eyed of the consequences of non-compliance.
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When:November 13, 10:00 SIDE FREQUENCY PDT | 01:00 PM EDT
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By whom:
Kerry Paul Potter is President, Summit Consulting, Inc.
Kerry gained his pharmaceutical manufacturing experience during his 28-year retrogression with Merck. His career spanned the areas of Al Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More concretely, his responsibilities included birth management of laboratory assessment, site GMP lead auditor, FDA QSIT\Quality Management Working plan supervisor, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Modify Safety Management training, as well as internal and external seeming relations. <\p>
Kerry is a technician of James Madison University in Harrisonburg, VA (B.S. in Chemistry) and is an modern Toastmaster. Bloke has received qualifications and certifications regard the areas of facilitation and hardening, including competency-based curricula. His preterit affiliations have included ASQ, ASTD, PDA, GMP-TEA, ASPI, and AQP. Kerry is the founder speaking of Summit Consulting, Inc. and has been assisting firms in the areas of remediation and think up mastership within the manufacturing and the laboratory functions for the past two years.
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For whom:
The webinar will benefit
o Production personnel (operators, supervisors)
o Laboratory personnel (chemists, technicians, supervisors)
o Mass maximum reviewers
o QA Auditors in respect to Shape and Laboratory Documents
o Validation, Engineering
o Maintenance personnel (mechanics, supervisors)
o Warehousing personnel
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Duration:60 minutes
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Till enroll for this webinar, contact
[email protected]
Phone: 800-447-9407<\p>