30thJuly - 1st August 2019
Mumbai
INTRODUCTION

Data Integrity requirements are among the most strenuous that regulated industries has to comply with. Data Integrity can result from lack of awareness, employee errors, failure to check accuracy of data, software or system malfunction, configuration problems with electronic data handling, or misconduct by employees. Your electronic records must be trustworthy and reliable across their entire data lifecycle, from initial data creation all the way through long-term archival. Data Integrity (DI) has become a focal point of FDA inspections, as is evidenced by the number of warning letters citing data integrity and the resulting number of import alerts. Company Quality Management Systems are being scrutinized as to how the integrity of raw data (both electronic and manual) generated in the Quality Control Laboratory and in Operations (Manufacturing and Engineering) can be assured. The FDA is now including recommendations for recipients to obtain 3rd party assistance when addressing DI issues.

With the number of inspections on rise, FDA auditors are on a close watch on pharmaceutical companies with the focus being on quality so that the drugs which are exported to the global market are safe to consume. A sincere and thorough approach to formulate this response is required in order to convince the FDA that the observations noted have been taken into consideration and a plan of action has been implemented. It has also been noted that an indefinite response to a 483 can lead to a warning letter.

Keeping all this in consideration, CPhI Conferences is pleased to announce the, ‘5th Annual Data Integrity, Reliability and Quality Metrics’ along with an extension to ‘FDA Inspections and Response to 483s’ Workshop scheduled scheduled on 30thJuly - 1st August 2019 at Courtyard by Marriott, Mumbai. This practical case-study and highly interactive content-driven workshop will enhance your knowledge to address the Data Integrity issues and upgrade your skills for effective response to a 483.

TRAINERS
Frances (Fran) M. Zipp
Lachman Consultant Services, Inc.
President & CEO
Linda Evans O’Connor
Lachman Consultant Services, Inc.
M.B.A, Vice President, Chief of Staff
Dr. Ron George
Lachman Consultant Services, Inc.
Director
SPEAKERS
Dr. Ranjana Pathak
Cipla Ltd.
President – Global Quality, Medical Affairs & Pharmacovigilance
Dr. Rajiv Desai
Lupin Limited
Executive Vice President - Corporate Quality
Mayur Parmar
Deputy Collector, Govt. of Gujarat
Former Drugs Inspector - FDA
Dr. Subhash Mandal
Vice President – Indian Pharmaceutical Association (IPA)
Chairman – Regulatory Affairs Division, IPA
Chandra Sekhar Satya
Reliance Life Sciences
Vice President-Corporate Quality
Dr. Subhash Pande
Zydus Cadila
Sr. Vice President - Corporate Quality
Anand Iyer
UL PURE Learning
Business Head, South Asia
KEY OBJECTIVES
Get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements
Understanding of what FDA and European inspectors expect from pharmaceutical companies with respect to Data Integrity
Learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System
Get equipped with key skills to ensure successful inspections of your manufacturing sites Understand how to establish an effective Data Governance system
Learn how to investigate Data Integrity issues in your organization
Live simulation exercise to work with your peers to effectively respond to a 483
Understanding the key strategies to be adopted during an inspection
WHY ATTEND?
  • Case studies and practical sessions on different aspects of Data Integrity, FDA inspections and Response to 483s
  • Address your most burning issues from the World Renowned Trainers and Industry Experts
  • Live simulation exercise to work with your peers to assess a system for data integrity and respondto a 483 effectively
  • Enhancing your skills to ensure integrity of the data along with effective ways to respond to a 483 and successfully conduct FDA inspections
WHO SHOULD ATTEND ?

Industries / Categories

Pharmaceutical Biopharma

Departments

Data Integrity Officers QA/QC Global Quality CSV Validation Compliance Manufacturing Analytical Development CRO’s and CMO’s Engineers Regulatory

Designations

Vice Presidents Assistant Vice Presidents HOD's Directors Assistant Directors Deputy General Managers General Managers Senior Managers Managers Principal Scientists Executives
WHO SHOULD PARTNER ?
  • Analytical Instrumentation companies
  • Software Companies
  • CROs
  • Laboratory instrumentation industries
TOP 5 REASONS TO PARTNER
RECENT MARKET UPDATES
MEET NEW BUYERS
NETWORKING WITH KEY DECISION MAKERS
DELIVER A TECHNICAL SESSION
SHOWCASE YOUR SOLUTIONS
PROGRAM AND AGENDA
  • 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

  • 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 The challenges on training everyone to the correct level

  • Implementing and Running a Robust Data Governance Program

  • Laboratory and Chromatographic Analysis

  • Managing Quality in a Global Environment

  • Invalidated OOS and Impurities

  • 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

  • Effective Ways to Respond to FDA Observations

  • FDA inspections: All time audit readiness – The need of the hour in the industry

  • Recent Trends and Review of 483s

  • Devising a CAPA for your 483s

  • Continuity and commitment after writing a thorough response

TOP COMPANIES ATTENDING
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GLIMPSES OF 2018