Rapid Screening Techniques in Analysis for the Pharmaceutical and Medical Device Industries
Sponsored by: Butterworth Laboratories / Wickham Laboratories Limited
- Rapid Microbiological Methods
- Rapid Screening Methods
- Elemental Impurities
Date: 1 October
Time: 3PM London/10AM New York
Screening of Excipients, APIs and Finished Products for Elemental Impurities and Biological Organisms
The adoption of rapid screening techniques for the quality assurance analysis of pharmaceutical products and medical devices is a slow process. Recently the pharmacopeias have adopted rapid techniques for the assessment of elemental impurities, which we will be discussing today. However, in the field of microbiology, while rapid methods are available, the majority of these have not yet been widely accepted by the industry as there are still many regulatory requirements for traditional testing methods.
David Riches will be discussing adoption of ICP as an instrumental technique, in place of the classical wet chemistry Heavy Metals test, to determine elemental impurity concentrations in pharmaceuticals and the work that this change will require within the industry. The new techniques have introduced increased specificity and sensitivity which although allowing more in-depth material composition analysis, has also raised the concern that elements and levels identified could lead to non-compliance. This presentation will briefly touch on ICP as a technique, appraise the benefits over alternatives and address the approaches companies are taking using rapid screening to give them the confidence of meeting regulatory requirements for elemental impurities.
A discussion of rapid versus traditional microbiological QC testing methods will be introduced by Dr. Lynne Murdoch. The focus will be on current sterility testing methods, assessing benefits as well as inherent issues such as lengthy testing periods and small test volumes. We will then also provide an overview of several of the novel rapid microbial methods (RMMs) now available in terms of methodology, efficacy, and how they currently fit in the regulatory framework. Novel RMMs can potentially provide faster, more sensitive results for quantifying and/or identifying a broad range of organisms - potentially reducing testing risk and improving overall safety; however, RMMs have their own limitations including the high cost of validation.
Whether you have already begun investigating your options or it's something you'll be starting soon, please join this webinar as this presentation should give you the confidence to properly assess your options for rapid methods and be prepared to maintain compliance in a changing regulatory environment.
Lynne Murdoch, BSc (hons), PhD, CBiol, MRSB,
Dr. Murdoch joined Wickham Laboratories Limited in 2014 as part of a strategic initiative to push forward research and development projects within the company. She received her degree in Microbiology and Immunology from the University of Strathclyde in 2007 and subsequently pursued a PhD in Microbiology/Electronic and Electrical Engineering. Building on her background in microbiology, Dr. Murdoch has spent her career gaining expertise in the identification and validation of new products, services and technologies for the life sciences field.
David Riches, BSc, CChem, MRSC,
Head of Analytical Operations
David started his career at Messers Sandberg Testing Laboratories which specialises in analysing samples for the construction industry. He joined Butterworth in 1986 as an Analytical Chemist specialising in Elemental Microanalysis. David is currently Head of Analytical Operations having previously held the posts of Analytical Operations Manager and Senior Manager of Inorganic & General Chemistry.
Key Learning Objectives
- Understand the screening techniques and rapid methods available for elemental analysis and sterility testing
- Understand the regulatory environment and impending changes around ICP and microbiological methods
- Discover some of the issues facing companies relying on traditional testing methods
- Learn about the challenges inherent in adopting rapid methods
- Analytical Development Scientist/Team Leader
- Business Development Manager/Supervisor
- Commercial Director
- Head of Microbiology
- Head of R&D
- Lab Manager/Supervisor
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- Project Manager
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- QC Manager/ Technician/ Scientist/ Associate
- Quality Director/Manager/Supervisor
- Qualified Person (QP)
- R&D Team Leader/Scientist
- Raw Materials Manager/Supervisor
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- Research Manager/ Supervisor/ Scientist/ Associate
- Senior Analytical Chemist
- Senior Laboratory Analyst
- Senior Microbiologist
- Senior Scientist
- Technical Lead
- Technical Manager
- Technical Support Manager