Basic Concepts of Validation

ISPE CEUs*: 1.3
Type: Classroom Training Course
Level: Fundamental

This course can be offered at your company site in its current format or customized to meet the needs of your organization.

Description

Validation is an integral part in the life cycle of any drug product. This course will provide participants with background and perspective on the purpose and key principles of validation, regulatory aspects, and documentation requirements.

Explore the use of a master validation plan, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols, and the relationship of validation to the good manufacturing practices (GMPs). Through experiential case studies and exercises, participants will learn how to prepare a validation protocol, analyze data, and prepare a final report.

Course Modules

• Course Presentation
• Validation – FDA Perspective
• Pelecon Manufacturing Co.
• Chocolate Chip Cookies
• Case Study: Beacon System Labeler
• Executed Protocol: Beacon System Labeler
• Protocol Directions
• Validation Master Plan: Biotech, Inc.
• Glossary
• References

Take Back to Your Job

• Discuss the concepts, terminology, and requirements for qualification and validation of pharmaceutical facilities, equipment, and processes
• Identify the key principles of validation
• Define the relationship between validation and GMPs
• Describe FDA inspection expectations for qualification and validation of facilities, equipment, and processes
• Draft a validation protocol, analyze data, and prepare a final report using an experimental case study and exercise

Attendance Suggested For

• Validation scientists, quality assurance and control specialists, manufacturing supervisors, technical support personnel, engineers, and all levels of management who want a fundamental understanding of qualification and validation of pharmaceutical facilities, equipment, and processes
• Professionals from service organizations and vendors who serve pharmaceutical clients

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.