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

Why Should You Attend:

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 Webinar:

• 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.

Danielle DeLucy
Owner, ASA Training and Consulting, LLC

Danielle DeLucy, MS, is the owner of ASA Training and Consulting, LLC, providing pharmaceutical and biologics-based companies with training and quality systems assistance in order to meet regulatory compliance. Danielle has been in the industry for over 15 years, serving in numerous quality management roles, such as the Director of Product Quality, where she oversaw sterility assurance practices and provided QA oversight of numerous filling and packaging operations.

Danielle began her career as a Quality Control Pharmaceutical Microbiologist, performing various tests for laboratory clients. She’s continued in the quality management arena while increasing her responsibility. She has helped to lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection.

Currently, Danielle assists companies facing warning letters and consent decrees as well as those wishing to improve GxP practices and establish more robust quality systems.

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