Data Integrity Remediation:
It is NOT a One-Time Activity!

Abstract:

With release of Data Integrity guidelines from FDA, MHRA, EMA and other regulatory bodies across the globe, data integrity compliance received limelight across the industry since 2015.  Looking at the trend of increase in warning letters on Data Integrity non-compliance, the industry jumped immediately into Remediation exercises to achieve compliance with the Data Integrity requirements.  Will one time exercise of Data Integrity Remediation be sufficient to demonstrate compliance? Let us discuss on this webinar to see how periodic review, the critical step in Data Integrity Monitoring helps to achieve overall compliance.

Key Takeaways:

  • Understand the key steps to be performed post completion of Data Integrity Remediation exercise at R&D, MFG and QC Laboratories
  • How to conduct periodic review process?
  • Periodic Review Checklist template

Top 6 Reasons to Attend

  1. You will have the opportunity to review the list of monitoring checks required to demonstrate Data Integrity compliance
  2. You will gain knowledge on how to conduct periodic review exercise
  3. Helps to establish a well-defined Data Integrity Program for your organization
  4. Determine the cost and effort required to conduct this exercise at your organization
  5. Access to the periodic review checklist that will help you to define the process/templates
  6. Interact with the speakers and clarify your questions on Data Integrity / Periodic Review process

SPEAKERS

Abhinaya Rajasekaran

Head – Compliance & Validation Services, Zifo RnD Solutions


Ms. Abhinaya is a Compliance, Validation and Data Integrity Consultant who heads the compliance department at Zifo RnD Solutions. She has consulted pharma, biotech, medical device, diagnostics and product development companies in devising their qualification strategy. Having worked with several global GxP, Data Integrity and ERES requirements ranging from US, UK, EU, Asia pacific, she has expertise in understanding the dynamics, specifics and commonalities in global regulations to provide pragmatic solutions.

Loganathan Kumarasamy

Head of US Compliance & Validation, Zifo RnD Solutions


Mr. Loga is responsible for managing validation and compliance services at Zifo RnD Solutions. He holds a Master’s degree in regulatory affairs from Northeastern University and RAPS RAC (US) certification holder since 2018.  With in-depth knowledge of Part 11, EU Annex 11, HIPAA, data integrity principles and applicable GxP regulations for computer systems, medical devices and laboratory systems, he has been providing consultation for top pharmaceutical and product development companies.