software development traceability matrix
Validating Rapid Microbiological Methods – Webinar By GlobalCompliancePanel
Overview
: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose.
All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs).
Because many RMM technologies consist of a combination of instrumentation, software, consumables and reagents, in addition to specific detection, quantitative or identification methodologies, it is important to develop a comprehensive and holistic approach to the validation process to ensure that the entire RMM system is suitable for its intended use. This seminar will provide an overview of how to design a meaningful validation program in order to effectively demonstrate that the new RMM is suitable for its intended use and is equivalent to, or better than, the existing method you intend to replace. Topics will include the development of User Requirements Specifications, the validation master plan, IQ, OQ and PQ expectations, and a comprehensive review of how to utilize USP Chapter 1223, Ph. Eur. Chapter 5.1.6 and the PDA Technical Report #33.
Areas Covered in the Session:
- Learn how to develop a validation strategy
- User requirements specifications (URS)
- Design Qualification (DQ)
- Supplier assessment/audit
- Functional design Specifications (FDS)
- Requirements Traceability Matrix (RTM)
- Developing test plan, including installation, operational and performance qualifications (IQ, oq and PQ)
- Pharmacopoeia testing requirements from the United States and European Pharmacopeias (USP and Ph. Eur.)
- Acceptance criteria
Who Will Benefit:
Senior management and laboratory personnel responsible for the conduct of microbiological testing and microbial control strategies in manufacturing and product/process development:
- Microbiology
- Quality Control
- Quality Assurance
- Manufacturing
- Validation
- Regulatory Affairs
- R&D
- Discovery
- Finance
- Directors
- Managers/Supervisors
- Scientists
- Technicians
- Operators
- Auditors
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
About the Author
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in the due diligence, validation, registration and implementation of rapid microbiological methods, pharmaceutical microbiology, Process Analytical Technology (PAT) and isolator design and qualification. Currently, Dr. Miller is the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com). In this position, he is responsible for providing microbiology, regulatory and quality solutions for the pharmaceutical, biopharmaceutical and medical device industries.
Intro Reqn Spec
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