Overview:

The Introducing GMP, Root Cause Analysis, and Understanding Validation (3 Day) Training Programme offers comprehensive training designed for individuals seeking to enhance their knowledge and skills in Good Manufacturing Practice (GMP), Root Cause Analysis, and Validation. 

Participants have the flexibility to take any combination of these courses or all three consecutively over three days.

Content Highlights:

Day 1: GMP Training

• Understand the need for GMP: Learn the fundamental importance of GMP in ensuring product safety, efficacy, and quality within the healthcare industry.

• What is GMP? Define Good Manufacturing Practice and its critical role in manufacturing processes.

• GMP and its link with Quality Assurance and Quality Control: Understand the relationship between GMP, QA, and QC and how they collectively ensure product quality.

• Define the GMP guidelines and how agencies enforce them: Review key GMP guidelines and the enforcement mechanisms of regulatory agencies.

• What are the relevant regulations? Identify the regulations that govern GMP practices and their impact on the industry.

• How the main regulatory agencies audit and enforce them: Learn about the audit processes of major regulatory bodies such as the FDA and EMA.

• Investigate the 4 Ps:

  • People: Assess the adequacy, experience, and training of personnel and the role of Qualified or Responsible Persons.

  • Procedures and Documentation: Explore the importance of SOPs, in-process controls, and thorough documentation.

  • Production Areas and Equipment: Examine requirements for premises, layouts, and equipment to ensure compliance.

  • Products and Components: Understand handling, storage, packaging, labelling, and management of non-conforming products.

• Identify potential GMP violations and their consequences: Learn to spot common violations and understand the implications of non-compliance.

• Use interactive case studies to analyse scenarios: Apply GMP principles to real-world scenarios through interactive case studies.

• Examine real reported incidents: Review actual incidents to learn from past errors.

• Determine behaviours that improve GMP: Identify and promote behaviours that enhance GMP compliance.

• Plan for workplace improvements: Develop actionable plans to improve GMP adherence in your workplace.

Day 2: Root Cause Analysis Training

• Investigate what a non-conformance or deviation is: Understand the definitions and implications of non-conformances and deviations.

• Terms, acronyms, and their application: Familiarise yourself with key terms and their practical applications.

• How to better define the problem or non-conformance or deviation situation or event: Learn effective problem definition techniques.

• Consider misconceptions when defining the problem: Identify common misconceptions and how to avoid them.

• Reflect on regulatory expectations: Understand the regulatory requirements for handling non-conformances.

• Regulatory requirements: Review the expectations of regulators such as the FDA and EU authorities.

• Common FDA and EU regulator inspection findings: Examine frequent inspection findings to avoid common pitfalls.

• Investigate the use of problem analysis: Apply structured problem analysis techniques.

• Techniques for data collection: Learn effective data collection methods such as walkthroughs, variance analysis, and interviews.

• Utilise risk management techniques: Implement risk management strategies to mitigate issues.

• Review different methods: Explore methods like Cause and Effect, Flow and Process Charts, and 5 Whys.

• Examine different types of causes: Identify probable, contributing, and actual root causes.

• Methods for verifying root cause: Learn techniques to confirm root causes accurately.

• Investigate the subject of Human Error: Understand human factors that contribute to errors.

• Review human characteristics and factors: Identify and address human failure types.

• Apply and review non-conformance or deviation case studies: Enhance learning through practical case studies.

• Identify potential deviations: Learn to spot potential deviations early.

• Use different potential real activities: Apply knowledge to real-world activities to manage deviations effectively.

Day 3: Validation Training

• Investigate the history and requirements for validation: Understand the evolution and importance of validation in manufacturing.

• What is validation? Define validation and its role in ensuring product quality and compliance.

• Regulatory requirements and expectations: Learn the regulatory expectations for validation processes.

• Understand the terms and the application of validation: Familiarise yourself with key validation terms and their applications.

• Discuss the terms used: Engage in discussions to clarify validation terminology.

• Evaluate the key stages of validation: Understand the stages involved in the validation process.

• Use the basic 'V' model for a simple approach: Apply the 'V' model to streamline validation activities.

• View a CD video and answer questions: Enhance understanding through multimedia resources.

• How far does Good Engineering Practice go towards meeting compliance? Explore the relationship between Good Engineering Practice and compliance.

• Use case studies to explore the causes and implications of non-compliant validation: Analyse real case studies to understand the impact of non-compliance.

• Analyse real scenarios: Apply learning to real-world scenarios to determine suitable actions.

• Determine suitable actions for workplace improvements: Develop strategies to improve validation processes in your workplace.

By enrolling in our comprehensive training programme, you will gain essential knowledge and skills to enhance GMP compliance, perform thorough root cause analyses, and ensure effective validation processes in your manufacturing operations.