ComplianceOnline

Good Documentation Practices (GDP)

Instructor: Alla Teresh
Product ID: 703874
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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.

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

Instructor Profile:

Alla Teresh, ASQ CQA, has over 10 years of comprehensive experience in documentation audit and management within the medical device industry. During her practice, she designed and implemented a document control system for a startup company that was audited for and awarded an FDA medical PMA and 510K, and CE Mark Approval for distribution in Europe. Her skills include a high level of proficiency in conducting technical reviews and managing quality system documentation.

Topic Background:

According to the FDA, if it isn't written down, it didn't happen. Along the same lines, if it isn’t written down clearly, it didn’t happen either. Good Documentation Practices describe the required activities and steps to use when recording data and other handwritten entries. Personnel, who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance.

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