Change Control – GMP Requirements and Regulatory Enforcement
What will You Learn:
Master the essentials of managing change control in molding processes with this highly interactive and practical training. Designed for clarity and applicability, you’ll dive deep into GMP requirements and regulatory enforcement strategies, covering everything from accurate documentation to comprehensive impact assessments and successful implementation strategies. Through engaging, real-life scenarios and practical exercises, you’ll learn how to effectively maintain quality and regulatory compliance during process changes. This course empowers you with the skills needed to immediately manage and document changes confidently and clearly.
Target Audience
Quality Engineers, Process Engineers, Project Managers, Automation Engineers , Process Technicians, Team Leaders
Key Learning Objectives:
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- Understand key GMP requirements and regulatory expectations for change control.
- Master effective documentation practices for managing change.
- Learn how to conduct thorough impact assessments to mitigate risk.
- Develop practical implementation strategies to maintain compliance and product quality.
- Gain hands-on experience through interactive case studies and group exercises.
Course Details
- Duration: 1 Day Onsite, 8 Hours
- Format: In-Person, Interactive, Small Group Setting (Max 12 Participants)
- Prerequisites: Basic proficiency in Excel and MS Word (or Equivalent)
- Certification Note: Key training for roles involving Quality Management and Regulatory Compliance
Agenda:
- Morning (4 Hours):
- Introduction to Change Control: Importance, GMP Requirements, and Regulatory Expectations (1 hr)
- Documentation and Effective Record-Keeping Practices (1 hr)
- Interactive Group Exercise: Real-World Change Scenario Analysis (1 hr)
- Quiz & Discussion: Key Concepts Check (1 hr)
- Afternoon (4 Hours):
- Conducting Impact Assessments: Step-by-Step Approach (1.5 hr)
- Implementation Strategies for Smooth Process Changes (1 hr)
- Hands-On Workshop: Developing a Change Control Implementation Plan (1 hr)
- Group Review, Feedback, and Q&A Session (30 min)
What You’ll Gain
- Solid understanding of GMP requirements and regulatory standards for change control.
- Confidence in managing and documenting process changes effectively.
- Practical skills in impact assessment and implementation planning.
- Insight into maintaining product quality and compliance during transitions.
Join the course
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Ready to streamline your change control processes? Register today for this practical, one-day course designed for immediate workplace application.
- Price: €1,800
- Scheduling: On Request – Contact Us to Book
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