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Biocompatibility Testing of Combination Devices – New Regulatory Guidance
Learn how to implement an efficient testing program for assessing the biocompatibility of your combination product’s device component, which incorporates the relevant requirements of ISO 10993-1, to satisfy both U.S. and international regulatory agencies.
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Are you Effectively Monitoring your Contract Lab?
Learn how to foster your relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny. Hear from two Eurofins’ Quality Assurance experts, as well as our guest presenter, Sue Schniepp with Regulatory Compliance Associates.
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Eliminate the ups and downs of staffing challenges
Learn how Eurofins Lancaster Laboratories PSS Insourcing Solutions helps clients meet the demands of their strong development pipelines without increasing headcounts. Our Insourcing expert, Beth DiPaolo, President of Eurofins Lancaster Laboratories PSS Insourcing Solutions, will discuss the paradigm shift away from temporary staffing to insourcing to accelerate successful outcomes for the Biopharma industry.
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Practical Guidance for Successful Mammalian Cell Banking & Cell Line Characterization
Learn about the various aspects of cell banking and cell line characterization, including GMP production or non-production master and working cell banks, end of production cell banks, and R&D cell banks.
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Developing a Comprehensive Tool Kit for Microbial Identification
Learn about the application of various microbial identification methods, strain-typing techniques, microbial classifications, and the benefits of a comprehensive reference database.
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Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
Learn about challenges presented by residuals in biopharmaceutical manufacturing, as well as analytical approaches for cell- and process-associated residuals, strategies for using a platform method technology and how to deal with matrix effects.
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Alternative Rapid Mycoplasma Testing Methods for Biopharma Products
Discover how a rapid method for mycoplasma detection can replace the 28-day compendial method and gain insights into a recent test method validation and regulatory submission experience for Argos Therapeutics.
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UV-C Treatment—a New Procedure for Viral Inactivation
Learn how manufacturers are simplifying the purification process and maintaining a sufficient viral clearance level with fewer purification steps using this new technique.
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Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies
Learn strategies for establishing the best and most cost-effective approach to a cleaning, disinfection and monitoring program.
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Best Practices for Extractables and Leachables Testing
Learn strategies for establishing an extractables study design, including the advantages and disadvantages of various analytical techniques. Also get tools to handle difficult sample matrices, Threshold of Toxicological Concern (TTC), and more.
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Effective Strategies for Managing Comparator Product Testing
Learn about strategies for sourcing and manufacturing comparator product testing, as well as the process for method development and tactics and challenges associated with stability studies.
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Outsourcing Cell Based Potency Assays: Perspectives from a Sponsor and a Contract Testing Laboratory
Learn about industry trends, regulatory expectations and strategies for outsourcing Cell Based Potency Assays.
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Critical Aspects of Antibody-Drug Conjugates: Structural Characterization and Analysis
Learn about delivering targeted therapeutic agents with greater selectivity and less toxic side effects.
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Efficient and Effective Approaches to Managing Raw Material Methods
Learn about strategies for ensuring compliance for Excipient and API method establishment—keys to success in today’s regulatory environment.
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Risk Management of Adventitious Agent Contamination in Biopharmaceutical Products
Learn how to avoid production delays through Eurofins’ Webinar on Risk Assessment & Mitigation of Adventitious Agents.
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