Course overview
This full‑day masterclass goes beyond the fundamentals of ICH Q9(R1) and focuses on how to operationalise the revised guideline in real‑world GMP environments. Participants will learn how to transform QRM from a compliance activity into a strategic, data‑driven decision‑making framework that strengthens product availability, contamination control, and organisational resilience.
The course blends practical exercises, scenario‑based workshops, and interactive simulations to help teams apply the new principles of subjectivity reduction, uncertainty management, proportionality, and lifecycle‑integrated risk thinking.
This programme is ideal for organisations seeking to modernise their QRM systems, align with evolving regulatory expectations, and prepare for the digital future of risk management.
CPD Hours: 6
Course Content
- Day 1
- Module 1: The new QRM landscape
- Module 2: Bias, uncertainty & decision quality
- Module 3: Advanced hazard identification
- Module 4: Proportionality & right sizing
- Module 5: Digital QRM & AI enabled risk systems
- Module 6: Building a future ready QRM programme
- Case Study - Risk scoring & risk based decision making
Speakers
Aneta Jell
Aneta Jell is a seasoned Quality Assurance professional with over 20 years of experience
across manufacturing, contract operations, and quality leadership in the pharmaceutical
industry. Currently serving as Quality and training manager at PaulPalmer limited she
oversees global contract manufacturing quality, ensuring GxP compliance, regulatory
alignment, and supply chain integrity. Her expertise spans GMP, ISO 9001, ISO 17025, and
QMS administration, with proven strength in audits, CAPA, deviations, and technical
agreements. A qualified QMS lead auditor with bilingual proficiency in English and Slovak,
Aneta is recognised for driving continuous improvement, fostering compliance culture, and
leading high-performing quality and HSE teams.
Farah Nadeem
Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.
Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.
In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.
Who Should Attend
Who should attend
This course is designed for a cross-functional pharmaceutical audience - anyone involved in making, reviewing, or approving risk-based decisions in GMP operations. Attendees include:
- Quality Assurance and Quality Control personnel
- Risk owners and decision makers
- Manufacturing & operations leaders
- Process development & validation specialists
- Engineering and Technical Support
- Regulatory Affairs professionals
- Supply Chain and technical operations managers
- Validation, Process Development, and Engineering roles
- Regulatory affairs teams
- Consultants, Auditors, and Service Providers
- Digital transformation and data analytics roles
