This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.
Documentation that is used in support of manufacturing, laboratory and clinical practices should adhere to GDP. This webinar will highlight how the use of GDP allows companies to comply with regulatory requirements such as Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) or the applicable quality management system (for example, ISO 13485, 21 CFR parts 11,211,312,and 820), and Good Clinical Practices GCP).
Why Should You Attend:
Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, all employees must follow good documentation practices.Documentation that is used in support of manufacturing, laboratory and clinical practices should adhere to GDP. This webinar will highlight how the use of GDP allows companies to comply with regulatory requirements such as Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) or the applicable quality management system (for example, ISO 13485, 21 CFR parts 11,211,312,and 820), and Good Clinical Practices GCP).
Areas Covered in the Webinar:
- What is Documentation
- Documentation System
- Types of Documents
- Good Documentation Practices
- Good Documentation Requirements
- Documentation Processing and Control
- Guidance Documents for GDP
Who Will Benefit:
This webinar will benefit:- Anyone who authors, reviews, and audits documents and records in FDA-regulated pharmaceutical, biotechnology, and medical device industries
- Clinical research associates
- Manufacturing/production personnel
- Laboratory personnel
- Research and development associates
- Document control associates
- Batch record reviewers
- QA/QC specialists
- Validation engineers
- Quality assurance auditors
- Regulatory compliance associates and managers
Course Provider
Alla Teresh,
