Course overview
Root Cause Analysis (RCA) is the process of discovering the root causes of problems to identify solutions. When used with critical thinking, the ability to think clearly and rationally, understanding the logical connection between ideas this provides a highly effective method for identifying the source of faults, failures, decision making, and undesired outcomes for processes. This approach is extremely effective when used by the pharmaceutical and associated healthcare industries to solve problems. In addition, RCA procedures with the application of critical thinking are an increasing focus by regulatory inspectors.
Often organisations waste a great amount of time and money in fixing the symptoms of a problem, rather than the problem itself. Using Critical thinking applied to RCA will enable you to solve problems far quicker, and much more effectively.
This one-day course introduces delegates to different RCA and critical thinking problem-solving tools and techniques which are then applied throughout a series of highly interactive and practical exercises putting these theories into practice to apply a systematic end-to-end process for analysing problems and decision making.
CPD Hours: 6
Course Content
- Day 1
- Background and defining RCA and critical thinking
- Steps in RCA and applying critical thinking
- Preventive and mitigating problems
- Diagnosing RCA
- RCA methodologies
- Critical thinking
Speakers
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.
Laura Brown
Dr Laura Brown is a QA and training consultant in the pharmaceutical industry. She has also worked as an Associate Facilitator at Cranfield School of Management. She has worked in senior management roles for companies including Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International where she gained extensive experience of problem solving and decision-making using RCA and critical thinking skills. Since completing her MBA Laura has co-authored several books on management including: Strategic Thinking (Be Your Own Strategy Consultant - Demystifying) Strategic Thinking), Developing the Individual, The Ultimate Book of Business Skills and Project Management for the Pharmaceutical Industry.
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.
Who Should Attend
Who should attend?
Anyone working in the pharmaceutical, biopharma, medical device and veterinary industries who wants to maximise RCA and critical thinking skills, particularly applied to problem solving and decision making including the following:
- Managers responsible for process and quality improvements
- Professionals working in R&D and production
- Quality managers, internal and external auditors, inspectors
- Line managers and supervisors
- Anyone involved in managing customer and/or supplier/CMOs, CRO relationships
- Problem solving team members and leaders
- Product or process designers
- Operational and production professionals
