Effective Document Management for Pharma, Biotech & Medical Device
Duration : 90 Minutes
Joy L. McElroy,
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more
In this 90 minute webinar attendees will understand the importance of documentation, writing it down. If you didn’t write it down, it didn’t happen!This is the position of the FDA and most regulatory agencies internationally.
Good documentation is essential for doing business in the GMP world world from manufacturing to selling the product.
It is also important for due diligence and regulatory inspections, and is necessity for the success of GMP manufactured products and services. While the regulations tell you what you must do, they don’t tell you how.
Based on industry best practices, this course makes it clear how to perfect your existing systems.
This course also addresses what documents need to be controlled, what documentation is needed to support your actual system and how to keep your documents current and compliant.
Course Objectives:
Upon completion of this 90 minute course attendees will increase their ability to implement efficient practices that meet full GLP/GMP/ICH, ISO, and other regulatory requirements.
Course Outline:
• Implied and explicit regulatory requirements for documentation
• Industry standards
• Management support
• The documents you need to control
• Components of document systems
• System administration
• Document review, approval, and revision
• Document distribution, retrieval, and archiving
• Understanding e-system requirements: validation, security, accountability, and audit trails
• Validation documents
• Standard Operating Procedures and other documents to support the system
• Writing sound procedures
• Consistency in format and terminology
• Training requirements and training documentation
• Remaining “inspection ready”
• Auditing the system
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Assurance Managers and Supervisors
• Validation managers and Supervisors
• Engineering Managers and Supervisors
• Manufacturing and Operations managers and Supervisors
• Laboratory managers, supervisors and analysts
• Consultants
• Senior quality managers
• Validation engineers
• Quality auditors
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
