Attend this highly interactive two-day GMP Problem Solving course and you will leave with an understanding of how to use a wide range of problem-solving tools to solve problems that occur in a pharmaceutical environment, and also learn how to take steps to avoid these problems occurring in the first place.
Inadequately dealing with problems, not getting to the root-cause of a problem and not taking effective correction and corrective action are becoming THE major findings at regulatory inspections. It is therefore critical that you deal with problems in a systematic, consistent, compliant and auditable way.
Who will the course benefit?
Our GMP Problem Solving course is aimed principally at anyone needing to be involved in problem solving within a pharmaceutical environment, including Quality Assurance, Quality Control, Engineering, Production and Process Improvement personnel.Course overview:
Many pharmaceutical manufacturing sites have gotten into difficulty in the past few years for being unable to deal with problems in a systematic, consistent, compliant and auditable way. With increasing GMP requirements to deal with problems adequately it is inevitable that how an organisation deals with problems, incidents and deviations will be inspected more closely at regulatory inspections. In order to avoid difficulties both now and in the future make sure you are up to date with current tools and techniques needed to deal with problems in an effective, efficient and compliant way.Our highly interactive Pharma Problem Solving course introduces delegates to a wide range of problem solving tools that can be used to help solve problems that occur in a pharmaceutical environment. During the course a large number of methods that can be used to deal with problems are introduced, explained and examples provided of when they may be used. The course focuses on ensuring that the correct cause of a problem is identified, that the right measures are employed to deal with the problem and that monitoring occurs to ensure that the problem has been solved for good. In addition the Pharma Problem Solving course looks at common reasons for problems and highlights how many systems have inadequacies within them that actually cause problems themselves.
Course contents:
- Types of problems and deviations
- GMP requirements for dealing with and documenting problems
- The new GMP Chapter 1 and Chapter 8 requirements for Problem Solving
- Tools used to grasp the situation
- Data gathering tools:
- Charts and Graphs
- Fishbone Diagrams
- Brainstorming
- Is/Is not, 5 “W”‘s and a “H”
- Root-Cause Analysis tools:
- Cause and Effect
- Pareto Analysis
- 5-Whys
- The differences between Correction, Corrective Action and Preventive Action
- Ensuring that the true cause is found
- Monitoring actions to confirm the correct steps have been taken
- Common reasons for problems
- Human error – or not?
- Problems with communication, documentation and training
- Being more proactive and less reactive
- Continual improvement mechanisms
- Managing deviations and outstanding actions
- The role of Senior Management with Problem Solving
- Risk management tools, such as HACCP and FMEA and how and when these can be used
- Documenting Deviations and Problems in a compliant manner
