GMP Requirements for Records and Reports
Duration : 90 Minutes
Peggy J Berry,
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, Read more
Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. The webinar will discuss key requirements for recording data, completing forms and other basic documentation requirements for the GMP compliant company. Furthermore, the current industry requirements for recordkeeping will be discussed.
This webinar will review the current regulations, guidance documents for GMP Documentation in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
Course Objectives:
Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for your GMP documentation .
'If it's not written down, then it didn't happen!' The basic rules in any Good Manufacturing Practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future. Regulatory inspectors, during their inspections of manufacturing sites, often spend much time examining a company's documents and records. Effective documentation enhances the visibility of the quality assurance system. In light of above facts, it is very important for every company to know about the records and reports related to GMP requirement.
Course Outline:
• IND and NDA content and format for CMC information
• Vendor selection and management for outsourcing early manufacturing
• Raw material selections and considerations
• Required SOPs and documentation
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
