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Date: 12th June, 2008
Location: web seminar, Canada
Summary:Pharmaceutical - Seminar
Production and Process Control play a critical role in any manufacturing organization. The various regulatory agencies tend to focus on issues that affect a company's ability to maintain control over their systems and procedures. Failure to provide adequate control can quickly result in regulatory compliance deviations which may lead to warning letters and 483 citations.
During this live web seminar series, Nick Campbell will discuss the primary issues concerning process control as they relate to the GMP guidelines. In addition to the specific requirements in the Code of Federal Regulations, he will discuss practices that can help make your daily operations more effective and efficient. Attendees will learn the specific CFR requirements for establishing a repeatable and consistent operation, with the course content including issues such as defining specifications, executing a solid validation program, and monitoring characteristics during production. The concept of change management will be discussed in detail, allowing the class to understand how to effectively and efficiently execute modifications while maintaining quality requirements and minimizing disruptions.
2-Session Series Discussion Points:
- Process Control procedures
- Approval of Processes and Equipment
- Validation Plans
- Environmental Controls
- Change Management
- Deviation Investigations
