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.
This training course is part of a collection of trainings which focus on leadership, innovation, strategy, communication, finance, problem solving and conflict management, to name a few key areas.
Benefits of attending
- Apply best practice tools and techniques to identify, and document the root causes of problems
- Propose and evaluate solutions to prevent problems recurring and manage regulatory inspection findings
- Communicate your findings and recommendations to colleagues and senior management
- Gain an overview of the increasing importance of RCA and critical thinking skills for pharmaceutical and biopharmaceutical and associated healthcare sectors
- Understand the critical thinking and application to RCA
- Be aware of key tools and approaches to apply critical thinking to RCA for pharmaceutical and associated healthcare industries
Speakers
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of CardiffDr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
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
