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Brian Nadel (Independent Consultant, EAS Consulting)
Date: Wednesday, May 1
Time: 9:45am - 10:30am
Track: Drug Manufacturing
Vault Recording: TBD
The FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years, indicate that validation is a consistent problem for the pharmaceutical industry. Data integrity- or a lack thereof - can have major repercussions for a firm as FDA expects that data be reliable and accurate. The crucial and often overlooked validation step can ultimately cost manufacturers untold amounts in R&D, materials, product recalls, submissions, and more.
EAS Independent Consultant, Brian Nadel, a former FDA compliance officer and investigator, will share his expertise and provide actionable steps to assess, improve and document data validation.
Key takeaways from this session:
• Regulatory agencies look to how data is generated and safeguarded as the main basis for quality inspections
• Data integrity must align with cGMP compliance standards and provide reliable evidence of the work the firm carries out
• Understanding that electronic data and the systems that generate and store that information are part of the data integrity landscape
• How to control Data Integrity issues commonly associated with Electronic Records