FALLS CHURCH, Va. (PRWEB) October 31, 2018
Join award-winning FDA compliance expert, author and Cerulean founder John Avellanet for Data Integrity: The Key to FDA and GMP Compliance workshop. After two days of 'total immersion' study, attendees will return to their offices with a better understanding through team exercises and case studies and honest no-holds-barred discussions with John and their fellow attendees.
Early bird pricing for FDA Data Integrity ends on Tuesday, Nov. 6.
FDA gives simple instructions to its investigators: “If initial findings indicate the firm’s electronic records may not be trustworthy and reliable … a more detailed evaluation may be warranted.”
That's the polite way of saying this is when to expect to receive a warning letter.
With the increased scrutiny on data integrity, establishing internal competency and assessment programs is essential.
Join award-winning FDA compliance expert, author and Cerulean founder John Avellanet for the interactive workshop: Data Integrity for Device and Pharma Firms, and Their Suppliers. He is recognized globally for his business-savvy pragmatic advice and engaging speaking style.
During the 10 workshop sessions, attendees will:
- Identify likely risks and select the most appropriate controls
- Work to review audit trails and case study situations to determine the data integrity failures
- Review case study validation tests to see if data integrity is actually being verified
- See hundreds of questions and audit points to consider for internal and supplier audits
- Understand what departments need to be involved — who should take a leading role, how, and why
- Draft a personal business case and plan for implementing a data integrity control framework
- And much more
After two days of 'total immersion' study, attendees will return to their offices with increased understanding based on team exercises and case studies, informative, detailed explanations and honest no-holds-barred discussions with John and fellow attendees.
Early bird pricing ends on Tuesday, Nov. 6.
Meet the Presenter:
John Avellanet, Founder Cerulean Associates LLC
John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style. Mr. Avellanet was the lead author of several certification courses on Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) supplier management for the US Regulatory Affairs Professional Society.
Who Will Benefit:
- Executive management
- Regulatory affairs
- Quality assurance/quality control
- Legal and compliance officers
- Clinical research directors
- Consultants/service providers
- CAPA specialists
- Compliance information managers
- GMP compliance officers
- GMP training managers
- Heads of internal audits
- QA documentation managers
- QA/QC managers and directors
- Quality systems managers
- Systems analysts
- Training personnel
FDA Data Integrity
for Device and Pharma Firms, and Their Suppliers
**Presented by FDAnews and Cerulean Associates LLC **
Dec. 4-5, 2018 – Arlington, VA
Early Bird Pricing: $1,597 (available until Nov. 6, 2018)
Regular Pricing: $1,797 (after Nov. 6, 2018)
Significant team discounts are available.
Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.