n the highly regulated industries of pharmaceuticals, biotechnology, and medical devices, proper qualification of equipment and systems is vital to ensuring compliance, quality, and safety. Our Qualification Training Workshop is designed to provide participants with an in-depth understanding of qualification processes, methodologies, and regulatory requirements. This hands-on workshop equips professionals with the necessary skills to perform effective qualification activities and maintain compliance in their organizations.
Workshop Objectives:
Understanding Qualification Principles
Participants will gain a comprehensive understanding of qualification principles, including the importance of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) in ensuring equipment and system reliability.Regulatory Framework
We will explore relevant regulatory guidelines, such as GMP (Good Manufacturing Practices) and FDA requirements, that govern qualification processes. Participants will learn how to align qualification activities with these regulations to meet compliance expectations.Qualification Lifecycle
The workshop will cover the entire qualification lifecycle, including the following key phases:- Planning: Developing a qualification plan that outlines objectives, responsibilities, and methodologies.
- Installation Qualification (IQ): Verifying that equipment is installed according to specifications and manufacturer guidelines.
- Operational Qualification (OQ): Testing the equipment or system under normal operating conditions to ensure it performs as intended.
- Performance Qualification (PQ): Validating that the equipment or system consistently operates according to predetermined specifications over time.
Risk-Based Qualification Approach
Participants will learn how to apply a risk-based approach to qualification, focusing on identifying and mitigating risks associated with equipment and systems. This approach ensures that qualification efforts are prioritized based on potential impacts on product quality and patient safety.Documentation and Reporting
We will discuss best practices for documentation throughout the qualification process, including qualification protocols, reports, and change control documentation. Participants will understand the importance of maintaining accurate records for compliance and audits.Hands-On Exercises
The workshop includes practical, hands-on exercises that allow participants to apply their knowledge in real-world scenarios. These exercises reinforce key concepts and enhance understanding of qualification processes.Case Studies and Best Practices
Participants will review case studies to gain insights into common qualification challenges and best practices. This analysis will provide practical examples of successful qualification strategies and lessons learned from industry experiences.
Who Should Attend?
This workshop is ideal for professionals involved in:
- Quality Assurance
- Regulatory Affairs
- Equipment Validation
- Process Engineering
- Compliance Management
Why Choose Our Qualification Training?
- Experienced Instructors: Our trainers are industry experts with extensive experience in qualification processes and regulatory compliance.
- Interactive Learning: We promote an interactive learning environment, encouraging participant engagement and discussion to enhance knowledge retention.
- Practical Insights: Attendees will gain practical insights and tools that can be immediately applied in their organizations to improve qualification processes.
- Networking Opportunities: Participants will have the chance to connect with peers and industry professionals, fostering collaboration and knowledge sharing.
Workshop Details:
- Duration: 1 days / 6 hours
- Location: CFI Classroom/ Customer site (In-house)
- Cost: IDR 17.000.000
- Materials Provided: Participants will receive comprehensive workshop materials, including handouts, templates and digital certificate.