- Because of the rise of data theft and ransomware, data integrity shouldn’t (and can’t) be handled internally alone. Data integrity needs to focus not just on information security, but also eliminating bias in the process ideally with 3rd party input.
- Data is one of the most important assets companies have. In order to protect it, companies need specialists that handle this with a complete understanding of the regulations and requirements set forth by the FDA.
- Compliance with 21 cfr part 11 and how that often doesn’t align with what an OEM installation package is going to provide you COTS.
By attending you can expect to learn the following:
- Reduction in lost man hours
- Protection of intellectual property
- Preventing negative press
- Ensuring patient safety and market competitiveness
- Ensuring audit inspection readines
Takeaway tools:
- Gap analysis, FDA issues, new business
Speakers:
🎤 Rob Eleuterio: Senior Manager, Validation, Compliance Group
🎤 Rick Dursch: Director of Data Integrity and Software Validation, Compliance Group
Moderator:
🎤 Khaled Moussally: EVP Corporate Development and Operations