Course Description:
Analytical instruments should be qualified and systems should be validated to demonstrate suitability for the intended use. This two day in-person seminar will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use. This interactive workshop will help attendees understand the instrument qualification and system validation processes and will provide templates and examples to develop inspection ready documentation.
Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, attendees will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course.
Learning Objectives:
- Learn about the regulatory background and requirements for laboratory instrument qualification and system validation
- Understand the logic and principles of instrument qualification and system validation from validation planning to reporting
- Understand and be able to explain your company’s qualification and validation strategies
- Be able to independently prepare execute test protocols, this includes setting specifications and acceptance criteria
- Understand how to review and approve qualification and validation protocols
- Be able to develop inspection ready qualification and validation deliverables
- Learn how to avoid and/or respond to FDA inspectional observations and warning letters
Complimentary Hand-outs:
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1. 70-page primer - Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber) 2. SOPs
3. Full Set of Qualification examples for an HPLC system
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4. Full set of Validation examples of a chromatographic Data System
5. Qualification conditions, frequency of requalification and acceptance limits for 20 laboratory instruments |
Who Should Attend
This seminar will be beneficial for the following personnel in pharmaceutical development and quality control laboratories and contract testing laboratories.
- Laboratory managers, supervisors and analysts
- QA managers and personnel
- Quality control unit directors and staff
- IT managers and staff
- Consultants
- Laboratory suppliers of material, equipment and services
Course Outline:
| Day One (8:30 AM - 5:00 PM) | Day Two (8:30 AM - 4:30 PM) | ||
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Note: Sessions indicated with (*) include one or more workshop exercises.
®GAMP is a registered trademark and stands for Good Automated Manufacturing Practice
Meet Your Instructor
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Dr. Ludwig Huber Director and Chief Editor, LabCompliance Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences. He served as a team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on laboratory equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press. For more information, visit www.ludwig-huber.com |
Register Now
Watch the live recorded streaming video of seminar over the Internet.
The seminar broadcast includes speaker videos and coordinated PowerPoint presentations.
Contact [email protected] or call +1-888-717-2436 to get registration details.
Terms & Conditions to Register for the Live Recorded Streaming Video of Seminar
Your registration is subject to following terms and conditions. If you need any clarification before registering for this video of seminar please email us at [email protected] or call +1-888-717-2436
Payment:
After receiving the payment, our team will send you the instructions to access live recorded streaming video of seminar. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellation Policy:
Once the video access is given to customer, cancellation and refunds cannot be made.
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