“DOCUMENTATION AND QUALITY SYSTEMS : What are we lacking ??”

WORKSHOP OBJECTIVES

In 2011, USFDA sent warning letters to several companies for the lack of …
“… written procedures for production and process controls, designed to assure that the drug products you manufacture have the identity, strength, quality and purity they are represented to possess …”

This workshop aims to help pharma companies and professionals inculcate Good Documentation
Practices for Production, Processes and Controls. Revisit your Quality Systems and ensure you have
loopholes fixed, both the obvious and those that tend to be ignored.

YOU SHOULD ATTEND
This course is intended for Supervisors, Team Leaders, Managers and VPs working in –

• Quality Affairs – Quality Assurance, Quality Control
• Regulatory Affairs
• Documentation and Compliance
• Production and Manufacturing
• Technical Operations
• Research and Development

WORKSHOP LEADER

NEIL GRUMBRIDGE
Neil Grumbridge was Head of Quality, Safety and Regulatory Affairs, at Health Protection Agency, UK. He is
currently an Independent Consultant, working closely with several pharma and biotech companies in
Europe.

Neil Grumbridge is registered as a “Qualified Person” under the transitional arrangements of the Medicines
Act. He is also a Chartered Member of the Institute of Biology with managerial experience in QC, QA,
Technical services, Production and general management. His special interests include Sterile processing,
QA/QC of sterile dosage forms, and most notably, Isolator technology and Application of Vapour Phase
Hydrogen Peroxide as a Bio-decontamination Agent, for which he has worked closely with world-renowned
experts in the field.

Neil Grumbridge has also been a member of Parke-Davis working party set-up to improve communications
and achieve the Investing in People award of the Training and Education Council. He has also been a
Member of Parenteral Society working party on Media Fills, Member of a PDA working party on the
Production and Use of BIs for Gaseous Bio-decontamination Process.

SCIENTIFIC OUTLINE

Essentials of a Quality Management System

• ICH Q10
• What is a QMS?
• Principles of ISO 9001:2000
• US and EU Requirements
• The Quality Statement
• Components of a Quality Manual
• Working Examples

Principles of Good Documentation (SOP and BMR)

• Document Management Systems
• Good Design
• How to Write Instructions Effectively
• Completion of Records, including Correction of Errors
• Maintaining Records as required by Law

Risk Management and Root Cause Analysis

• ICH Q9
• Principles of Risk Analysis and Risk Mitigation related to Product Life Cycle
• Some Frequently Used Techniques
• Why good Root Cause Analysis (RCA) is so important
• Working Examples

Investigating Analytical OOS (Out of Specification Results)

• A specific type of RCA
• Why investigating OOS effectively is so critical
• Working Examples
• Change Control
• Design and Implementation of a Simple but Compliant Change Control Programme
• Examples of Useable Documentation

Deviation Management

• Planned Deviations
• Unplanned Deviations
• Documentation