ComplianceOnline

EFFECTIVE INVESTIGATIONS AND CORRECTIVE ACTIONS (CAPA) Establishing and resolving the root causes of deviations, problems and failures

Instructor: Michael Anisfeld
Product ID: 701025
  • Duration: 90 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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This course teaches tools and techniques that can be employed to get to the root causes of unexpected quality events, and help resolve them in a lasting, GMP compliant manner.

Description

The course examines actual situations, guiding participants in effective investigation resolution and determining solutions to effect proper corrective action.

When unexpected events happen—you cannot follow an SOP and need to deviate from it, or you obtain an out-of-specific action test result, or your supplier’s raw materials marginally fail specific action and you desperately need the material—what do you do? A few years ago, the standard reaction to an unexpected event was to ignore it or make an attempt to quickly fix it. Today, such reactions are unacceptable when working in a GMP environment. FDA’s strategy for GMP implementation for the 21st century—part of its quality systems approach—demand that proper investigations and corrective actions take place and be documented. Not only do you need to investigate the event to determine what happened, but you need to find out why the event happened and resolve it in a manner that prevents recurrence. It’s sound GMP, and makes good business and economic sense. A well-managed CAPA (corrective and preventive action) program not only provides effective and mandated regulatory compliance, but also yields enhanced productivity.

As part of FDA’s “GMPs for the 21st century” program, performing effective investigations into deviations and failures has become a key element of risk management and GMP improvement, and has become a key focus during regulatory inspections.This course teaches tools and techniques that can be employed to get to the root causes of unexpected quality events, and help resolve them in a lasting, GMP compliant manner.

Areas Covered in the seminar:

  • EU and US GMP requirements for failure investigation
    • How the GMP authorities want you to investigate failures and quality events.
    • Effective investigations tools:
    • Interview skills
    • Detective skills
    • Documentation skills
    • CAPA—corrective action and preventive action programs—what they are, and what FDA wants from you
    • Being in control—essentials of a CAPA program
    • Root causes
    • what they are and how to find them
    • Key considerations in effective analysis and CAPA analyses
    • When pursuit of 'root cause' is a waste of time
    • Event and causal factors analysis
    • FDA’s out-of-specification guidance and US requirements for effective investigations
    • Out-of-specification (OOS), out-of-trend (OOT), out-of-expectations (OOE) incident investigations Documentation of investigations
  • Quality event definitions
    • Tools for effective investigations:
    • Brainstorming
    • Ishikawa (Fishbone) analyses
    • Pareto analysis
    • Force field diagrams
    • Six-Sigma analysis
    • Kepner-Tregoe® analysis
    • Tools for effective fixes:
    • Failure mode effect analysis
    • Hazard and critical control points (HAACP)
    • Fault tree analysis (FTA)
  • Case Studies:
    • Laboratory out-of-specification incidents
    • Manufacturing failures
    • Manufacturing deviations

At the end of the course you will:

  • Understand what an effective investigation is, and what it is not.
  • Be able to implement tools that will allow the company to rapidly determine the root causes of deviations, problems and failures.
  • Implement a sound and effective CAPA program.
  • Know which tools to use in which situations, and how to sell management on effective corrective action and implementation.
  • Be able to satisfy the regulatory authorities by performing effective and valid investigations.
  • Use the tools taught in this course to incorporate cost-saving methodologies into your company’s failure investigations.

Who will benefit:

  • Quality managers
  • Auditors
  • Production managers and top management interested in learning the value of good investigations, as well as how to enhance the QA investigative function as a valuable cost-savings and quality-improvement tool
  • Consultants
  • Auditors and government inspectors will find this course particularly useful in enhancing their inspections and capabilities.

Instructor Profile

Michael Anisfeld, is senior consultant for Globepharm Consulting specializing in GMP/Quality activities for the healthcare manufacturing industries. In his current position he numbers among his clients United Nations Agencies, national regulatory agencies (including the US-FDA) and more than 200 pharmaceutical, medical device, biotechnology and bulk pharmaceutical companies in North America, Europe and Asia. Mr. Anisfeld has established and directed quality control, quality assurance, production and materials management functions in the industry. He has instituted innovative, cost-effective auditing Programmes for his clients, ensuring that they pass regulatory inspections the first time. With over twenty-five years expertise in the healthcare industry, Mr. Anisfeld has held senior management positions in international technology transfer, quality assurance, quality control and production.

In the course of his career, he has designed pharmaceutical, medical device and bulk pharmaceutical chemical facilities in seven countries. A member of the faculty of the University of Illinois, where he lectures in pharmaceutical technology, Mr. Anisfeld holds higher degrees in Pharmaceutical Technology (M.Sc.), Management (MSM) and Business Administration (MBA). An active member of many European and American regulatory and technical associations, he has served on the Board of Directors of the Parenteral Drug Association (PDA) and been chairman of its quality control and aseptic processing task groups. He currently serves on the FIP Task Force on Counterfeit Drugs and other international industry forums. An acclaimed international lecturer on the subject of GMP and quality topics, Mr. Anisfeld is also a prolific author on these subjects. He is the editor and author of many texts, including: International Drug GMPs, International Device GMPs, and Guide to FDA Pre-Approval Inspections, Sterile Pharmaceutical Manufacturing, and PDA’s monograph Validation of Aseptic Processing of Liquid Drug Products.

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