[vc_row][vc_column][vc_column_text css=”.vc_custom_1563454804998{padding-bottom: 25px !important;}”]Three Key Representatives from Lachman Consultants will be traveling to India on July 30 – August 1 for the 5th Annual Data Integrity, Reliability, and Quality Metrics Workshop. This 3-day interactive training event features experts from Lachman Consultants, Frances Zipp, President & CEO, Linda Evans O’Connor, Head of Business Processes and Regulatory, and Dr. Ron George, PH.D., Director.

Day 1 topics include:

  • Current Regulatory Trends, Data Integrity – Setting the Scene
  • Data Integrity Beyond the Lab
  • Data Integrity – Evaluation and Risk Assessment
  • Quality Culture and Cultural Excellence
  • 21 CFR Part 11: From Paper to Electronic Recorders to Safeguard Data

Day 2 topics include:

  • Data Integrity – Role of Integrated Learning System
  • Data Integrity, Site Inspections and Response to Warning Letter – FDA Perspective and Expectations
  • Data Integrity and the Indian Pharmaceutical Industry
  • Data Integrity – DI Training and the Behavioural Elements
  • Implementing and Running a Robust Data Governance Program
  • Laboratory and Chromatographic Analysis
  • Managing Quality in a Global Environment
  • Invalidated OOS and Impurities

Day 3 topics include:

  • FDA Inspections: All-time Audit Readiness
  • Effective Ways to Respond to FDA Observations
  • Critical parameters to be considered during Site Inspections to ensure integrity of the data along with techniques to effectively respond to a warning letter – Indian Government Perspective
  • Recent Trends and Review of 483s
  • Devising a CAPA for Your 483s
  • Continuity and Commitment After Writing a Thorough Response

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Contact us for more information on the event:

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