CAPA - Root cause and risk management

Instructor: Dr. Norman Howe
Product ID: 700997
  • Duration: 40 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2008

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

Participants will learn how to write CA reports that will be used as written & how a well maintained CAPA system will save the company time and money.


This course summarizes the cGMP requirements for Corrective Action Preventive Action (CAPA) and prepares participants to complete CAPA investigations on their own.

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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