Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences

Description:

This webinar will begin with an explanation of the process and how it originally conflicted with all regulatory bodies world-wide and how it now can be applied, with minor adjustments, to counter those original difficulties. The webinar will also discuss when the process should be used, how it should be staffed, and the process for its use.

Finally, the webinar will detail each of the steps of the process and the problem-solving tools that are used.

Why Should You Attend:

Today, the Global 8D Problem Solving Process has become a standard in many industries as a problem-solving and improvement process to determine the root cause of complex multi-dimensional problems requiring multiple functions interacting to solve.

Unfortunately, the process as originally structured, was at odds with both FDA and ISO expectations and requirements in one very critical area. The 8D process essentially placed corrective action verification before implementation rather than after it. This approach placed the emphasis of verification on the implementation of the corrective actions rather than on their effectiveness which is a crucial tenant of ISO and other regulatory requirements.

As taught in this webinar, the 8D process is so effective in determining root causes that tailoring the process to meet regulatory requirements is simply a matter of understanding how to effectively apply the approach.

Areas Covered in the Webinar:

• The 8D problem solving process explained

• How to apply the 8D process so it is in compliance with both ISO and other regulatory bodies

• When to utilize the 8D process

• Who are the players/team members in the process?

• 8D implementation steps

  • D0: Plan
  • D1: Use a team
  • D2: Define and describe the problem
  • D3: Develop interim containment plan
  • D4: Determine, identify, and verify root causes and escape points
  • D5: Choose and verify permanent corrections (PCs) for problem/nonconformity
  • D6: Implement and validate corrective actions
  • D7: Take preventive measures
  • D8: Congratulate your team

• Implementing a compliant CAPA effectiveness check

Who Will Benefit:

Any member of a cross functional project team that has the potential opportunity to lead that project.

• Engineers
• Marketing Associates
• Product Managers
• Program Managers
• Contract Managers
• Project Managers
• Research & Development Associates, Managers, and Directors
• Design Engineers
• Manufacturing Managers

Charles H Paul
President, C H Paul Consulting Inc

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.

Topic Background:

It is a complete and thorough approach which can be applied to risk management CAPA root cause investigation, and project management problem solving.

At the heart of the 8D Problem Solving Process are the eight disciplines. The eight disciplines include:

• D0: Plan
• D1: Use a team
• D2: Define and describe the problem
• D3: Develop interim containment plan
• D4: Determine, identify, and verify root causes and escape points
• D5: Choose and verify permanent corrections (PCs) for problem/nonconformity
• D6: Implement and validate corrective actions
• D7: Take preventive measures
• D8: Congratulate your team

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