Why attending the Masterclass: Analytical Method Validation and Transfer
Attending the Masterclass on Analytical Method Validation and Transfer can benefit professionals involved in the development, manufacturing, quality control, and regulatory affairs of pharmaceuticals and biopharmaceuticals. This masterclass covers the fundamentals of analytical method validation and transfer, including regulatory guidelines, method selection, optimization, validation, and lifecycle management. The course will provide practical guidance on how to develop robust, reliable, and compliant analytical methods for use in the quality control of pharmaceuticals and biopharmaceuticals. Additionally, attendees will learn how to successfully transfer analytical methods between laboratories, manufacturing sites, and regulatory agencies. By attending this masterclass, participants will gain a deeper understanding of the critical role that analytical method validation and transfer plays in drug development and commercialization, and will gain practical skills and knowledge to improve their own practices in this area.
- By attending this Masterclass you will:
- Learn about the latest regulatory requirements: The masterclass will provide you with an in-depth understanding of the latest regulatory requirements for analytical method validation and transfer, including ICH guidelines, US FDA, and EMA requirements.
- Gain practical knowledge: The masterclass is designed to provide practical knowledge on method validation and transfer, including hands-on exercises and case studies.
- Improve your skills: By attending the masterclass, you will improve your skills in method validation and transfer, including selecting the right method, optimizing the method, and documenting the process.
- Networking opportunities: The masterclass provides a great opportunity to meet and network with other professionals in the field of analytical method validation and transfer.
- Career advancement: By attending the masterclass, you will enhance your knowledge and skills in analytical method validation and transfer, which can help you to advance your career in the pharmaceutical, biotechnology, and medical device industries.
Day 1:
Session 1: Introduction to Analytical Method Validation and Transfer
- Analytical method validation process
- Regulatory guidance on method validation and transfer
- Differences between validation and verification
Session 2: Method Development
- Understanding the principles of method development
- Choosing the right methodology for the intended purpose
- Key considerations in method development for drug substances and drug products
Session 3: Analytical Method Validation
- Method validation parameters and acceptance criteria
- Designing validation experiments and protocols
- Method validation documentation and reporting
Day 2:
Session 4: Analytical Method Transfer
- Key considerations in method transfer
- Differences between method validation and method transfer
- Risks and challenges in method transfer
Session 5: Case Studies and Group Exercises
- Analysis of case studies involving method validation and transfer
- Group exercises to reinforce concepts learned
Session 6: Method Lifecycle Management
- Continuous method monitoring and optimization
- Revalidation and change control
- Risk management and mitigations
The trainer for this masterclass on Analytical Method Validation and Transfer is a highly experienced industry professional with expertise in analytical method development, validation, and transfer. They have extensive experience in the biopharmaceutical industry, and have successfully developed, validated, and transferred a variety of analytical methods for drug and biologic products. The trainer is also knowledgeable in regulatory requirements for analytical method validation and transfer, and is committed to sharing their knowledge and expertise with course attendees. They will provide practical examples and case studies to facilitate learning, and will be available to answer questions and provide guidance throughout the masterclass.
The Analytical Method Validation and Transfer masterclass is designed for professionals involved in the development, manufacturing, quality control, and regulatory affairs of pharmaceutical products. This includes:
- Scientists and researchers involved in method development, validation, and transfer
- Quality control and assurance professionals responsible for ensuring product quality and analytical method performance
- Manufacturing personnel involved in implementing and managing analytical methods for production and processing of drug products
- Regulatory affairs professionals responsible for navigating complex regulatory environments and ensuring compliance with relevant guidelines and regulations.
This masterclass is also ideal for professionals looking to expand their knowledge and stay up-to-date with the latest analytical method validation and transfer techniques and regulations. Whether you are an industry veteran or new to the field, this course will provide you with the tools and knowledge you need to succeed in today’s competitive pharmaceutical industry.
The fee for attending this two-day masterclass is 1,199 € per person. However, if six or more attendees register from the same company, a 30% discount will be applied to the total registration cost. This includes all course materials during both days. Attendees will also receive a certificate of attendance upon completion of the masterclass.
Note: the 30% discount will be applied to the total registration cost of all attendees from the same company. For example, if six attendees register from the same company, the total cost for the group will be discounted by 30% of the original price, bringing the total registration cost down to 839.3 € per person. This discount applies to all attendees from the same company who register for the course.