GMP Requirements for Records and Reports


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

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, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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