Description
The Pharmaceutical Validation Management Professional Certification Program includes an introduction to the principles behind the international regulations. These regulations are designed to assure effective validation and qualification procedures, commonly referred to as good validation practice.
Validation of equipment, services, systems and processes is vitally important in the medicines and healthcare products industries. Regulatory authorities require documented evidence that manufacturing processes will consistently result in products meeting predetermined quality standards. This program provides an introduction to validation and to the regulations and guidance that apply to it. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.
Essential to validation is the provision of documented evidence verifying that manufacturing processes will consistently result in products meeting predetermined quality standards. This program describes the purpose, content and use of validation master plans, project validation plans, and other documentation for validation projects in the medicines and healthcare products industries.
Before equipment can be used routinely in production, it must first be commissioned and, if necessary, undergo Installation Qualification (IQ). This program describes commissioning and IQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.
This program offers an introduction to operational qualification (OQ) and performance qualification (PQ). Having undergone Installation Qualification (IQ), before equipment can be used routinely in production, it needs to undergo Operational Qualification (OQ) and Performance Qualification (PQ). This program describes OQ and PQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.
This program offers an introduction to the international principles and regulations behind equipment cleaning validation. Manufacturers of medicines and healthcare products must establish, validate and maintain an equipment cleaning program. This is a regulatory requirement because validated cleaning procedures contribute to the assurance of product purity and safety. This module provides a comprehensive account of equipment cleaning validation requirements and procedures. It follows the work of a pharmaceutical company’s validation team as they establish and validate the cleaning program for a new production line.
This program continues to offers an introduction to the international principles and regulations behind computer systems validation. Course objectives include the following: to offer an understanding the computer systems life-cycle and the fundamentals of computer systems validation. In the medicines and healthcare products industries, computerized systems used in automated manufacturing or laboratory processes to which Good Manufacturing Practice requirements apply need to be validated. This section describes the planning of such validation. It follows the work of a pharmaceutical company’s team as they validate the dispensary control system for a new production line.
Additionally, the program describes the design, development and installation phase, the validation phase, and the operation and maintenance phase of the validation of computerized systems in medicines and healthcare products manufacturing environments. It continues to follow the progress of a pharmaceutical company’s project to validate a new dispensary control system.
Courses included in this program are as follows: 1) Validation: Computer Systems Part One; 2) Computer Systems Part Two; 3) Equipment Cleaning Validation; 4) Operational/Performance Qualification Protocols; 5) Commissioning and Installation Qualification; 6) Master Plans and Documentation; and 7) Principles and International Regulations.
