CAPA - Root cause and risk management

Participants will learn what it means to have control over deviations so that failures can be prevented before they happen. They will learn how to write CA reports that will be used as written. Participants will learn how a well maintained CAPA system will save the company time and money.

Areas Covered in the seminar:

• The Regulatory Requirements and draft guidelines.
• Root Cause Analysis techniques plus.
• Investigation- asking the right questions.
• Assignable cause –testing & verification.
• The difference between fixing the symptom and correcting the root cause.
• Contributing causes.
• The importance of an open, honest, and self correcting culture.
• What constitutes verification/validation of effectiveness?

Who Will Benefit:

• Supervisors
• Managers & technicians in Production
• Engineering
• Quality Control & Assurance
• Any personnel who perform investigations
• Write or revise deviations

Instructor Profile:

Dr. Norman Howe, has held many management positions in the pharmaceutical industry, most in production at BASF. He has led a number of cross functional cost reduction, product development, and business optimization teams. He has lead teams that have developed more than a dozen new products and installed more than $60M in capital. He has authored articles on compliance, chemistry, and general management. He serves as an expert witness. He is a member of ISPE and the American Chemical Society. Norm Howe got his BS in chemistry at UC, Berkeley, and a Ph.D. in chemistry at UCLA under DJ Cram.

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