Certificate program content:

Pharmaceutical Quality Management System (ICH-Q10)

Defining CAPA
FDA 483 findings
CAPA Processes and Procedures
Implementing a Quality Management Software Solution

Program learning outcomes:

· Discuss the expectations that GMP regulatory authorities have of investigations, CAPAs and investigation reports

· Describe how accident/incident models can be used when conducting an investigation

· Differentiate between root cause, contributing causes and proximal cause

· Discuss why human error is not a valid root cause

· Discuss a model that can be used to illustrate multiple layers of control and mitigation

· Given an investigation report with deficiencies, identify ways to improve the report

· Benchmark current best practices in CAPA and investigations with your peers

· Learn practical strategies and techniques you can teach to all your employees

· Obtain sample forms for conducting investigations and case reviews

· Demonstrate to yourself the value of a cross-functional team and also ways that experts demonstrate their expertise

· Understand the components of a well-written report and Identify better ways of finding the real reasons behind the category of “human error” — and ways to better control and mitigate those factors

This certificate program, equivalent to 39 hours of training, will enable participants to understand root cause analysis as a procedure for ascertaining and analyzing the causes of problems in an effort to determine what can be done to solve or prevent them. Consisting of lecture notes, complimentary video lectures, and a book, this program is designed to provide attendees with an in-depth understanding of how to analyze a system to identify the root causes of problems.

Learning Objectives:

  • Enhance problem solving effectiveness by providing methodologies for more deeply analyzing problem situations.
  • Clarify the difference between analytical and creative thinking, and when each is most useful.
  • Promote the ability to provide problem-solving support in situations where one is not an expert in the process or technology involved.
  • Expand the range of tools available for analysis of problem situations.

Who Should Attend:

Quality, safety, risk, and reliability managers, process engineers, technicians, operations supervisors and personnel, process owners, occurrence investigators, analysts, maintenance directors, reliability professionals, and anyone who wants to improve their ability to solve recurring problems should attend this training. Manufacturing markets include core manufacturing markets in Pharmaceuticals, machinery and computer equipment, chemical and allied products, fabricated metals, electronics, transportation, and measurement/controlling industries. Service markets that could effectively leverage this course would include consulting/business services, financial services, wholesale/retail, transportation, utilities, and government.

Program in Good Manufacturing Practice (ICH-GMP).

Program Outline:

1- Introduction to Quality Management Systems and Quality Assurance and Good Manufacturing Practices (ICH-GMP) 

2- Essential Elements of GMP & Technical and Regulatory documents for QA: (SOP, OOS, Deviation and Validation Reports, Change Control, and Product Quality Review)

3- Audit and Inspection management

4- Handling Product Complaints and Recalls

Learn how to write SOPs (Standard Operating  Procedures) and about various other technical documents.

Learn about GMP validation requirements for QA

Learn about the Guidance on writing a product Quality Review for QA