26th - 28th June 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 on 26th - 28th June 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
Chandra Sekhar Satya
Reliance Life Sciences
Vice President-Corporate Quality
Mayur Parmar
Deputy Collector, Govt. of Gujarat
Former Drugs Inspector - FDA
KEY OBJECTIVES
Get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements
Get a deeper understanding what FDA and European inspectors expects from pharmaceutical companies in regard to Data Integrity
Learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System
Learn how to prepare your company for an successful inspection in regard to Data Integrity
Understand how to establish an effective Data Governance system
Learn how to investigate Data Integrity issues in your company
Live simulation exercise to work with your peers to respond to a 483 effectively
Understanding the key strategies to be adopted during an inspection from the regulators
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

Manufacturing CRO’s & CMO’s QA/QC Global Quality CSV Validation Compliance Engineers Quality Risk Regulatory Data Integrity Officers Analytical Development Laboratories of pharmaceutical companies

Designations

Executives Principal Scientists Senior Managers Managers General Managers HOD’s Deputy General Managers Assistant Directors Directors Associate Vice Presidents Vice Presidents
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
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GLIMPSES OF 2018