WORKSHOP LEADER

Dr. Siegfried Schmitt

Principal Consultant

Dr.Siegfried Schmitt, Principal Consultant, joined PAREXEL Consulting in 2007. He provides consulting services to the medical device and pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems and Competitive Compliance. He is the PAREXEL practice lead for Quality by Design.

Dr Schmitt’s areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug substances and drug products, for all types of formulations. He is a seasoned and experienced auditor, providing support to clients pre and post inspections or audits.


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OUR SPEAKERS

10 TOPICS
25 SPEAKERS
25 SPONSERS
2 LOCATIONS

KEY TOPICS

The 2 Day Conference and workshop will be mix of presentations, hands-on practical sessions, interactive workshops, case studies and panel discussions. Participants are encouraged to put forward their questions prior to the conference; these will be answered and discussed anonymously during the workshop.



What is Data Integrity and why is it an Issue now?

What is industry’s reaction to Data Integrity?
What are the recent regulatory changes for Data Integrity?
Role of Management- What should be the management structure for DI accountability
What factors to consider before establishing a DI plan
How is DI validated? - Is your company Inspection ready? Really?

Learning Objectives

Understand the current FDA and EU GMP regulations and guidance impacting data integrity from paper records to hybrid and electronic systems.

Understand the FDA requirements for data integrity, MHRA Data Integrity guidance March 2015 and WHO guidance from September 2015.

Learn what is required for a data governance system from senior management through to staff in laboratories, manufacturing and quality assurance.

Understand the data life cycle and how it is linked with the business process and where problems can occur for both paper records, hybrid systems and electronic systems.

What are the recent regulatory changes for Data Integrity

How is DI validated

COURSE OUTLINE

Introduction to Course and Instructor.

Why is Data Integrity Important?

Role of Management in Data Integrity.

US 21 CFR 211 and EU GMP Chapter 4: Complete data v raw data.

Ten Compliance Commandments for Laboratory Systems

Facilitated Discussion / Workshop on Key Data Integrity Topics such as paper records

PARTNERS


Bio-Pharma
India-Brief
ip-techex
Technology-Network
agaram tech-vertical



Limited Seating Available! Register Today!
Be first to confirm your seat.

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Throughout product life cycle to ensure patient safety

Biotrains is one of the world’s leading provider of business conferences, training,managed events and Consulting services for Pharmaceutical,Biotech, Healthcare and Medical Device industry.



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    +91226 534 4333

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