GlobalCompliancePanel to organize RAPS pre-approved webinar on "Good Documentation Practices for GMP Operations"

Top Quote A RAPS pre-approved webinar on the topic, "Good Documentation Practices for GMP Operations" is being organized by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, on March 19. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion. End Quote
  • San Jose, CA (1888PressRelease) March 19, 2013 - Description:This webinar discusses the criticality of Good Documentation Processes (GDP) in the pharmaceutical industry.

    The FDA is clear and unambiguous in its declaration: "If it isn't written down, it didn't happen". In practice, this means that if it isn't written down clearly, it didn't happen either. This explains the importance of documentation, proper documentation at that.

    It is extremely important for professionals, no matter whether they are in production or in a laboratory, or are conducting investigations or are about to finalize product release, to implement sound documentation processes. This is a requirement under 21 CFR, Part 211. All pharmaceutical manufacturing and support areas come under this regulation.

    During this session, the Expert will take up for discussion the elements that go into GDP. He will also show examples of these practices as they happen in the pharmaceutical arena. Attending this session is important because Good Documentation Practices describe the required activities and steps to use when recording data and other handwritten entries. Personnel, who work with documentation must be informed of these requirements, should recognize their significance to their job and be aware of the consequences of non-compliance.

    When:March 19, 10:00 AM PDT | 01:00 PM EDT

    By whom:
    Kerry Paul Potter is President, Summit Consulting, Inc.
    Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, as well as internal and external public relations.

    Kerry is a graduate of James Madison University in Harrisonburg, VA (B.S. in Chemistry) and is an advanced Toastmaster. He has received qualifications and certifications in the areas of facilitation and training, including competency-based curricula. His past affiliations have included ASQ, ASTD, PDA, GMP-TEA, ASPI, and AQP. Kerry is the founder of Summit Consulting, Inc. and has been assisting firms in the areas of remediation and project management within the manufacturing and the laboratory functions for the past two years.

    For whom:
    The webinar will benefit
    - Production personnel (operators, supervisors)
    - Laboratory personnel (chemists, technicians, supervisors)
    - Batch record reviewers
    - QA Auditors of Production and Laboratory Documents
    - Validation, Engineering
    - Maintenance personnel (mechanics, supervisors)
    - Warehousing personnel

    Duration:60 minutes

    To enroll for this webinar, contact
    webinars ( @ ) globalcompliancepanel dot com
    Phone: 800-447-9407

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