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GlobalCompliancePanel, USA
2010-11-16
To ensure success, and avoid those frustrating, embarrassing discussions of missing or doubtful data, employees recognize and must follow Good Documentation Practices (GDP). These practices apply to all pharmaceutical and medical device manufacturing, and their support areas. GDP describes 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, recognize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the applicable US and EU expectations of documentation plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena. 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. Don't let poor documentation practices become a compliance issue for your company.
The Learning Benefits/Objectives: - What the regulations say about documentation practices
- Meanings of your signature and/or initials on a document
- How to correct errors and omissions
- Current and correct use of "NA"
- Attaching raw data to records
- Date and time formats
- Rounding and limit expression determinations
Areas Covered in the Session: - 21CFR and Eudralex references to documentation
- Signatures and signature logs
- Comments and explanations
- Entering numerical data
- Handling raw data (charts, strips, printouts)
- Blanks
- "Do's" and "Don'ts" of documentation practices
Who 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
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Kerry Paul Potter: - 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.
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Deadline for Abstracts:
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2010-12-09
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Registration:
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Tuesday, November 16, 2010
10:00 AM PDT | 01:00 PM EDT | | | Live live online training only for one participant | | |
| | | | | | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | | |
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E-mail:
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webinars@GlobalCompliancePanel.com
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