This 2-day workshop provides comprehensive and highly interactive training in current regulatory expectations and industry approaches to ensuring Data Integrity and compliance with 21 CFR Part 11, with a specific focus on electronic data and computerized systems. Example topics include:
- Data Integrity -- Risk-Based Approach to Preventing & Detecting
- Data Life Cycle Design and Controls
- Validation for Data Integrity
- 21 CFR Part 11: Electronic Records, Electronic Signatures
- EU Annex 11
- Health Authorities' Data Integrity Guidances
- Data Integrity Compliance Plans and Accountability Structures
- Techniques to Identify and Investigate Aberrant Data Patterns
- Reviewing electronic data and metadata--such as audit trails
- Risk assessment tools
- Preparing for FDA inspections of facilities and electronic data
- Case study of hands-on live system audit to detect data integrity issues
- And much more
The Level 1 workshop is designed for personnel responsible for data integrity (i.e., those who create, review and approve data in any CGXP Operational role)—as well as novice and advanced Quality & Compliance auditors, Health Authorities, System Users, IT professionals, CSV and Engineering, Management, and more. Participants will have the opportunity to discuss recent industry standards, regulations and guidances and current regulatory expectations, case studies, audit and inspection approaches, assessment tools, and FDA 483s and warning letters. Participants will also be able to conduct a hands-on inspection of a live computerized system to detect data integrity issues and define appropriate corrective and preventative actions.
The 05-06 March 2018 (Level 1) Data Integrity Workshop, the 07-08 March 2018 (Level 2) Data Integrity Governance, including Train-the-Trainer & Advanced Topics Workshop, and the 09 March 2018 (Level 3) Critical Thinking & Advanced Auditing for Data Integrity Workshop will be held will be held at the lovely La Valencia Hotel in La Jolla, California, http://www.lavalencia.com/, a vintage boutique hotel and spa situated atop La Jolla Cove, overlooking the beautiful Pacific Ocean. A limited number of sleeping rooms have been reserved at a discounted rate for “Green Mountain Quality Assurance” of $249/night; please hurry to reserve by phoning +1 800.451.0772 or +1 858.454.0771 no later than 02 February 2018.