Conference HomeBack to Basics: Good Documentation to Facilitate Compliance and Electronic Batch Record Implementation
Session 107
Manufacturing Operations Track
Significant numbers of FDA 483 Observations for documentation have been issued for FY 2010. Industry requires additional information and specifically targeted actions to aid in prevention of future observations. Companies define user requirements and implement EBR based on the functionality of the software, thus overlooking the documentation and actual work flow resulting in quality and validation issues as well extended project schedules.
Session Description
During this session you will discuss the GMP Preamble to provide the quality compliance requirement for controlled documentation. An analysis of documentation observations cited during FDA Inspections will be presented and a top ten list of actions to take to prevent documentation observations by regulatory authorities will be provided. Learn how to utilize good documentation to effectively implement Electronic Batch Records (EBR).
At the conclusion of this session, participants will be able to:
- Understand the regulatory requirements for controlled documentation
- Apply practices to ensure appropriate good documentation practices are in place to avoid FDA 483 observations
- Analyze existing documentation compliance
- Understand the criticality of addressing documentation and work flow as the foundation for defining, executing, and implementing EBR effectively
Leaders
Speakers
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom
Who Should Attend
- Manufacturing/Operations
- Service Providers
- Suppliers
- Regulators
Communities of Practice Members that will Benefit
- API
- Biotechnology
- C&Q
- Good Control Laboratory Practices
- Operations Management
- Oral Solid Dosage
- Process/Product Development
- Project Management
