FDA data integrity requirements are among the most strenuous that regulated industries have to comply with.
And the FDA is keeping pressure on those with data integrity shortcomings — issuing a growing number of warning letters every year for the last few years.
Simply put, to avoid citations, your electronic records must be trustworthy and reliable across their entire data lifecycle — from initial data creation through long-term archival.
Compliantly managing your business' essential data can be an overwhelming, even mind-boggling undertaking.
Thankfully, there's an expert with deep knowledge who can explain complex FDA data integrity regulations in simple 'what to do, how to do it' language.
And that's why you must plan NOW to attend this upcoming interactive workshop presented by FDAnews and Cerulean Associates LLC, a leading consulting firm.
Award-winning FDA compliance expert, author and Cerulean founder John Avellanet will be your workshop leader. He is recognized globally for his business-savvy pragmatic advice and engaging speaking style.
A former FDA and DOJ prosecutor calls Mr. Avellanet, “The best in the business. Period.”
After two days of 'total immersion' study, you'll return to your office with increased understanding based on team exercises and case studies … informative, detailed explanations … and honest no-holds-barred discussions with John and your fellow attendees.
Here's a summary of the key data integrity issues you can expect to hear about in this must-attend workshop:
Data Integrity: What’s Really Required?
What FDA, EMA, Health Canada and other regulating agencies expect; what you can learn from others' warning letters; typical FDA investigator tactics and questions about your data integrity.
Suppliers and Data Integrity: Who’s Accountable?
How to manage data integrity with CROs; overseeing data integrity at your CMO and other contracted services; contractual components to address data integrity risks; handling SaaS providers, hosted IT systems and cloud computing.
Practical Realities: The Business Costs of Poor Data Integrity
Legal pitfalls for senior management, practical quality costs and real world examples and case studies.
Critical Data Integrity Elements to Prove Compliance
The 8 practical elements of data integrity; a simplified approach to risk-based data integrity controls; verifying data integrity controls at suppliers; qualifying personnel ; conducting quality audits; monitoring, metrics and communication; policies and SOPs to consider.
Modern Validation Protocol
Validation by risk level; sampling and test cases, and supplier-provided validations; taking advantage of the traditional DQ\IQ\OQ\PQ format; featuring FDA-approved test cases as examples.
Mapping Your Data Chain-of-Custody
Data mapping defined; how to map your data flow across the data lifecycle; benefits of mapping your chain-of-custody (both business and the FDA).
Advanced Tactics to Cut Costs and Reduce Workload
Change management -- from preapproved to emergency; containing costs with cross-functionality; incorporating data integrity compliance daily; how to create a site master data integrity compliance plan; data integrity governance.
Data Integrity, Recordkeeping and Archival Controls
Records you must retain to prove good data integrity controls; basics of bit rot and other risks; developing a media migration strategy; qualifying record/archival storage vendors.
Building Your Business Case for Defensible Data Integrity
Sample data integrity action plan including 9 brainstorming questions; how to talk to senior management about data integrity; and more.
During each of 10 workshop sessions, you'll participate in interactive group projects… review case studies … draft practice business cases, plans and communications … and more.
You'll also simulate investigative scenarios using real data from real inspections — and even determine whether or not warning letters should be issued!
Consider this. The 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 you can expect to receive a warning letter.
Don't let things get to this point of a warning letter. Attend Data Integrity: The Key to FDA and GMP Compliance.
It's the right thing to do — for your company and for yourself.