Data Integrity for Drug and Device Manufacturers : Avoiding Breaches and Closing Gaps

Danielle DeLucy

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Data integrity has taken center stage in new ways and accuracy is vital. Mistakes will break you. Even the smallest, most unintentional error in your recordkeeping and documentation can cast doubt on all your data, which can lead to stoppage, delays and regulatory enforcement

The Data Integrity for Drug and Device Manufacturers: Avoiding Breaches and Closing Gaps webinar is going to be your GPS for compliance. It will explain what data integrity is, how to protect it, how to spot problems and what the FDA expects. It will also show you how to prove the strength of your data, even during a virtual FDA inspection. All so you can stay compliant and get to market more quickly.

Data integrity isn’t just a method or concept, it’s a mindset. A corporate culture built on data integrity includes risk-based oversight and prevention systems, as well as recruiting, training and retaining employees who will work responsibly to ensure the integrity of company data.

Data Integrity for Drug and Device Manufacturers addresses the five leading solutions for data integrity issues. In addition to creating a corporate quality culture, they are: developing corporate leadership that’s engaged in quality (and is visible); investigating and addressing problems under a top-notch corrective and preventive action (CAPA) system; ensuring that employees responsible for entering, modifying, maintaining, reporting and reviewing critical data have the right skill sets and dedication to high quality and ethical standards; and implementing performance management that’s practical, balanced and effective.

The session explains the top 10 data integrity traps you must sidestep to ensure compliance. These include document control, electronic data systems, analytical documentation and materials management. It will enable you to:

  • Create a risk-based approach to detecting data integrity problems
  • Identify and mitigate factors contributing to the loss of data integrity
  • Use the Compliance Maturing Curve
  • Define a data integrity audit strategy
  • Identify and implement the four essential characteristics of a culture of quality

Plus, the agency’s guidance on data integrity and compliance with current good manufacturing practices (cGMPs), included in the appendix, answers manufacturers’ most common questions and lets you know exactly what the FDA means by data integrity.

Data Integrity for Drug and Device Manufacturers: Avoiding Breaches and Closing Gaps is the solution you need to ensure data integrity and get your products to market faster. Will your data integrity hold up?

Who Will Benefit

  • QA/QC staff
  • Regulatory affairs personnel
  • Vendor/supplier management
  • Inspection managers
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Danielle DeLucy, Pharmaceuticals, Biotechnology

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

Get in touch

(315) 632-0735,
(315) 750-4379