Count Every Second Until the Event

2024-01-18 8:30

Course Overview

The field of Quality Risk Management (QRM) has often been overlooked and considered the "orphan child" of Pharmaceutical Regulations for over 15 years, both by industry professionals and regulatory bodies. Recognizing the need for change, ICH has recently revised the ICH Q9 guideline, making it more practical and easier to understand for all stakeholders involved.

In today's state-of-the-art Pharmaceutical Quality System (PQS), the understanding and appropriate implementation of QRM principles are crucial for maintaining compliance. The revised ICH Q9 has gained substantial importance and power over the years, with major regulatory agencies like the FDA and EMA referring to it in nearly all new or revised pharmaceutical regulations.

To bridge the gap between theory and practice, our masterclass on Implementing Effective Quality Risk Management under ICH Q9 (R1) goes beyond introducing the revised ICH Q9 and delves deep into the practical implementation of QRM in an up-to-date Quality System. Led by Christof Langer, a renowned expert in the field, this training provides a comprehensive understanding of QRM principles, using real-life examples to demonstrate its application.

Moreover, the training places a strong emphasis on the day-to-day environment of risk-based decision making. By attending this course, you will gain the necessary knowledge and skills to make informed risk-based decisions and avoid audit findings by aligning with regulators' expectations regarding ICH Q9 QRM.

The interactive nature of this virtual training ensures an engaging learning experience. Through a mix of theoretical educational lessons, polls, and workshops, participants will actively participate, exchange ideas, and apply their knowledge to practical scenarios.

Why join the event

Key takeaways of the program

Gain a comprehensive understanding of Quality Risk Management (QRM) principles and their practical application in the pharmaceutical industry

Acquire in-depth knowledge of the revised ICH Q9 (R1) guidelines and their significance in maintaining a compliant Pharmaceutical Quality System (PQS)

Identify the key requirements and changes in the revised ICH Q9 (R1) and develop strategies for effective implementation within your organization

Learn practical approaches and best practices for integrating QRM into various aspects of a Pharmaceutical Quality System

Enhance your skills in risk-based decision making, understanding how to proactively manage risks, and aligning with regulators' expectations to avoid audit findings

Explore real-life examples and case studies to gain practical insights into QRM implementation and develop the ability to apply QRM principles in your day-to-day operations

Network and collaborate with industry professionals in interactive sessions, polls, and workshops, fostering knowledge sharing and learning from diverse perspectives

Receive a certificate of completion, acknowledging your enhanced understanding of QRM principles and the revised ICH Q9 (R1), strengthening your professional credibility

Who Should Attend

An event precisely for you

Quality Assurance Professionals
Quality Assurance Professionals
Quality Control Personnel
Quality Control Personnel
Regulatory Affairs Professionals
Regulatory Affairs Professionals
Engineering and Facilities Management Personnel
Engineering and Facilities Management Personnel
Supply Chain and Materials Management Representatives
Supply Chain and Materials Management Representatives
Manufacturing and Production Managers
Manufacturing and Production Managers

The speaker

Meet your trainer

Christof Langer holds a Masters degree in Biotechnology as well as Business Administration and has been Managing Director of OSConsulting, a Life Science Consultancy firm located in Austria with clients on 4 continents, since 2009. During this time he also Co-founded 3 Biotech Start-ups where he served as CEO resp. COO and was involved in various deal makings.

Prior to his entrepreneurship, Christof was Managing Director of a Czech and a Swiss entity of Baxter (today Takeda) and held several other management roles at Baxter as well since 1996. Christof is an examined lean Six Sigma Black Belt and an examined IRCA Pharmaceutical Lead auditor with triple digit audit experience from 27 years of conducting audits all over the world. Furthermore, he is a certified Risk Manager acc. to ONR 49000 ff.

Christof Langer

Christof Langer

Founder, Trainer & CEO
OSConsulting - Austria

The Curriculum

What you’ll get from this exclusive event

Fresh Content

Knowledge is only useful when it is relevant. This event is based on the latest research, best practices and industry information. As a result, we close events with a strong knowledge base that helps achieve same-day results.


Meet and collaborate with like-minded professionals across the globe. Grow your professional network, exchange ideas, and learn more about the industry with your own peers, together.


Experience comes with practice, and this event will guide you on the right path in becoming a well renowned expert in your field. You will learn through a combination of lecture-based content, real-life case studies, and a more hands-on experience.

Q&A Session

By joining this class, you will be given the opportunity to constantly engage with your peers and raise your concerns, questions, or doubts you may have pertaining to the subject. And, receive well-founded, well-thought-out answers to your every need by leading experts in the industry. 

sign up

Getting registered is easy!

Valid number
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.