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.
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
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.