Quality Management System Effectiveness: The Principles of ICH Q10 – Pharmaceutical Quality System Guidance & Improving your Bottom Line Using Quality Risk Management Techniques

Live, Interactive Training Program

A Comprehensive 2-Part Live Webinar Training Program

Available Live On-Demand
Instructor: Peter Calcott Ph.D. Biography>>>

Schedule & Deliver this Live Training Program Privately to Your Group

This two part live training program is designed to examine the ICH Q10 Pharmaceutical Quality System principles and demonstrate why it is important for you to implement it effectively in order to improve your competitiveness in the marketplace and to improve your operational effectiveness. A direct result of this implementation will be a compliant operating system and decreased compliance risk. This radical change in how we operate under these guidances is a major step forward and unless it is done well, we will not be able to take advantage of its benefits. For once, the regulators have given us help in the form of the ICH Q9 Quality Risk Management guidance to aid its implementation. In spite of this many companies still labor and are hesitant to start the implementation, not being sure where to start. This series will examine some of the major components of your Quality Management System and walk you through step by step how you can measure their effectiveness and how to improve them to serve you better, resulting in improved economics and decreased compliance risk.

Please scroll down for complete details of both parts of this exclusive live training program.

Part 1 - Quality Management System effectiveness: ICH Q10 Principles, Impact of Failure on COGS, QRM Fundamentals & Impact of Reactive Versus Proactive systems (Completed)

Live, Interactive Training Webinar

The objective of Part I of this live interactive webinar series isto build a foundation of what the purpose of ICH Q10 is and how to implement it into your current QMS. Understanding the impact of the effectiveness of this system on COGS is critical in order to improve your economic and compliance position. We will discuss how to measure its effectiveness and how with this information we can build a more rugged system to aid in improving your operational excellence, becoming more compliant and driving down costs of operation.

This Live Presentation Will Cover (Part 1):
-The principles of ICH Q10 – Pharmaceutical Quality System
-Why we should change the way we operate – what’s in it for me?
-The intrinsic and extrinsic elements of quality that influence COGS
-The principles of QRM and what they can do for me
-Using the principles in key reactive systems such as investigation and CAPA processes

Learning Benefits:
-What factors influence my COGS in the quality arena and what can I do about them.
-Why QRM can help me in making the decision what to work on first.
-What I need to know about QRM and how it works.
-Where it can help me in both proactive as well as reactive systems.
-How to put it into practice in key QMS components.

Webinar outline and time breakdown:

9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Why we need to change how we operate,
Implementing ICH Q10,
Measuring effectiveness of the QMS,
QRM principles,
10:30 AM Break
10:40 AM Implementing QRM into operations,
How it works in proactive versus reactive systems,
Selective system implementation,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

Part 2 - Quality Management System effectiveness: Building and Improving Your Processes to Become More Efficient and Focused, to Decrease Compliance Risks.

Live, Interactive Training Webinar

Part 2 will focus on the impact of using the techniques of QRM in building or modifying your processes to serve you in strengthening your efficiency creating more rugged business processes that offer efficiency of operation and more compliant outcomes. Selected systems will be highlighted to illustrate how these techniques can aid in streamlining both proactive as well as reactive systems in your QMS. Those systems highlighted will include auditing and inspection processes, investigational processes, annual product reviews, vendor management programs, change management, training and education and CAPA programs.

This Live Presentation Will Cover (Part 2):
-Creating vendor management programs that identifies potential weaknesses
-Auditing and inspection processes to add value
-Investigational processes that aid in getting to the root cause
-Annual product reviews that create actions to improve operations
-Change management that customers want to use
-Training and education that improves operator performance
-CAPA programs that keep you ahead of the curve.

Learning Benefits:
-Understanding what is important to the business and what is not.
-Building processes that serve you rather than you serving them.
-Learning when doing nothing is not only acceptable but the correct thing.
-Creating systems that inspectors will be impressed with.
-Creating systems that your employees do not avoid or work around.

Webinar outline and time breakdown:

9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Vendor management program,
Auditing and inspection processes,
Investigational processes,
Annual product reviews,
10:30 AM Break
10:40 AM Change management,
Investigational processes,
CAPA systems,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training program includes the following for each registered attendee:

  • A Copy of the presentation slides
  • A Copy of ICH Q9 – Quality Risk Management
  • A Copy of ICH Q10 – Pharmaceutical Quality System
  • A certificate of training for attendee records

Who should attend:
The following individuals or disciplines will benefit from attending this training program:

  • Regulatory Compliance Staff
  • Quality Assurance personnel
  • Quality Control personnel
  • Auditors
  • Manufacturing Managers
  • Regulatory Affairs Professionals

Schedule & Deliver this Live Training Program Privately to Your Group


Instructor: Peter Calcott Ph.D.

Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>