Data Integrity Requirements in Pharmaceuticals

Data integrity is a major concern for FDA and EU Regulatory Agencies, with warning letters and EU GMP inspections highlighting failures. ALCOA++ Plus principles outline regulatory expectations for data integrity.
IMG Hitendrakumar Shah
Webinar Id: 60024
Single Attendee
Group Attendees


The learning objectives are firstly understand the data integrity requirements in Pharmaceutical organisations

How Pharmaceutical organisation personnel can ensure compliance and be able to defend their positions. 

The benefits are, 

  • The person’s understanding about data integrity will be clear
  • The person working in pharmaceutical will become vigilant while generating and handling the data
  • The data integrity awareness will be increase in the company.

Areas Covered in the Session:

The major points covered include;

  • Some FDA citations on Data Integrity
  • Introduction to Data Integrity
  • How to design system and Processes to assure integrity of Data
  • Role of Blank formats in controlling Data Integrity
  • Controlling master templates
  • Practical implementation – GAP analysis strategy, DI Training, Presenting DI status, QA role/oversight
  • Points triggering the thought process

Who Will Benefit:

  • Quality Assurance
  • Quality Control
  • Pharmaceutical IT Compliance
  • Qlobal QA
  • Corporate QA and QC
  • IT personnel working or related to pharma IT support

Speaker Profile

Hitendrakumar Shah is a Quality oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality engineering, Quality auditor, pharmaceutical regulations and regulatory audit compliance.

The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines. The key competencies include, Quality Compliance, Supplier Audit, build systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc.

Independently handled - Quality assurance and Quality Control department for more than 13 years.

Audits faced- USFDA (8 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (9 times) , Yemen MOH, Digemid (Peru), Russian Authority audit etc.

Analytical Background: The analytical background includes, physical, chemical, microbiological testing of raw material, finished product & Stability samples. Handled the chromatographic instruments - HPLC, GC, FTIR, UV Visible spectrophotometer, AAS etc.