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Clara Fargo
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Qualification Validation Training Course & Certification
Beginner and Intermediate
4.3
★★★★★
94% Recommended
1 hour
178 active users
2 points
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About
The Qualification & Validation Training Course & Certification is designed to provide a comprehensive understanding of qualification and validation principles in pharmaceutical, biotechnology, and life sciences industries. The course focuses on ensuring equipment, systems, and processes consistently perform as intended in compliance with regulatory requirements.
This course covers validation lifecycle concepts, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). It also includes process validation, cleaning validation, computer system validation (CSV) basics, documentation practices, deviation handling, and regulatory expectations. Upon successful completion, learners receive a certification demonstrating competency in qualification and validation practices.
Who Should Enrol?
- Pharmaceutical Manufacturing and QA/QC Professionals
- Validation and Engineering Teams
- Quality Assurance and Compliance Professionals
- Regulatory Affairs Professionals
- Production and Operations Staff
- Computer System Validation (CSV) Beginners
- Pharmaceutical and Biotechnology Employees
- Life Science, Pharmacy, Chemistry, and Engineering Graduates
What you will learn
Understand the fundamentals of qualification and validation, including key definitions, scope, regulatory expectations, and importance in regulated industries.
Learn the principles of process qualification and validation, including different validation types, methods, and lifecycle approaches.
Gain knowledge of essential validation planning and documentation, including Validation Master Plans (VMP), protocols, reports, and pre-validation activities.
Develop an understanding of specialized validation areas such as equipment qualification, cleaning validation, computer system validation (CSV), and analytical method validation to ensure consistent product quality and compliance.
Course Syllabus
- What is Validation?
- The Need for Process Qualification & Validation
- Scope & Importance of Validation
- Major Advantages of Validation
- Types & Methods of Validation
- Selecting the Right Validation Approach
- Activities Before Commencing a Validation Project
- Validation Master Plan VMP
- Basic Concepts: Equipment Qualification Framework
- IQ/OQ/PQ in a Tablet Compression Suite
- The FDA 3-Stage Process Validation Lifecycle
- Validation Protocol and Validation Report
- Cleaning Validation
- Cleaning Validation Failure — A Real Lesson Learned
- Computer System Validation CSV
- Analytical Methods Validation
- Change Control & Revalidation
- Change Control: When Revalidation is Non-Negotiable
- What Every GMP Professional Must Know
Course Benefits
Fully compliant
This course follows the guidance of Annex 13 of the European Commission's GMP guidelines
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.
Reliable and trustworthy
This course was written by McCarthy Consultant Services Inc (Canadian specialists in regulatory work to support the global pharmaceutical, biotechnology, medical device, food, natural health products and cosmetic industries). You will also stay up to date with any legislative changes in GMP relating to IMPs as our training courses are constantly monitored, reviewed and updated.
Our Certified Customers
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