Good Documentation Practices (GDP) and Record Keeping Best Practices

Description

Good Documentation Practices is an essential element in regulated manufacturing and laboratory environments. Personnel in these fields need to closely adhere to GDP in order to ensure an auditable account of work performed. Good Documentation Practice (GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. GDP is required for all documentation included in a fully developed quality system.

Objectives

By taking this training, you will learn:

• General principles, definition, application, and importance of GDP
• Regulatory applications of GDP
• Document and record creation, approval, handling, and retention
• Document maintenance and modification
• Time/date recording and rounding rules
• Proper way of dealing with deviation, use of signature and initial, correction of errors and omissions
• Practice applying ALCOA to paper and electronic documentation
• Identify methods to assess quality documentation to support inspection of clinical trials
• Recognize appropriate ways to address deficiencies in documentation
• Raw data attachments to documentation
• Documents are written according to the US FDA, Health Canada, ICH, and WHO Guidelines

Who Should attend

• Manufacturing/production personnel
• R&D laboratory personnel
• Scientists and researchers
• Batch record reviewers
• QA/QC specialists
• Validation specialists
• Quality auditors

Education approach

• This training is based on both theory and best pratices used in the implementation and management of GDP
• Lecture sessions are illustrated with examples based on case studies
• Practical exersises are based on a case study which includes role playing and discussions

Speaker

Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer