Microbiological Method Validation and Testing of Sterile and Nonsterile Pharmaceutical Products from Drug Development to Product Release and Post-Market Surveillance

Sponsored by: Sartorius
Speaker
  • Managing Partner and Principal Microbiology Consultant, MicroGuard Consulting
    Biography
      Mr. Guardino is the managing partner and principal microbiology consultant for MicroGuard Consulting, LLC, a company that exists to assist the Pharmaceutical and Biotechnology industries, and Compounding Pharmacies with microbiological compliance and concerns. In this role, Mr. Guardino has served as an international consultant on four continents over the past seven years. Prior to this role, Mr. Guardino served as the Director of Microbiology for AAIPharma Services Corp. where he oversaw a full-service contract Microbiology Laboratory in support of the Pharmaceutical and Biotechnology industries. In this role, Mr. Guardino interacted with many clients and client companies offering consulting and testing services. After earning a Master of Science Degree from the University of Buffalo in Medical Technology with a concentration in Microbiology, he performed research in Microbiology and Biotechnology for several years. Mr. Guardino has also held positions as a product development / quality assurance supervisor for rapid microbial diagnostic products and as a principal scientist during the development of PCR-based diagnostic products for a JNJ Company. His Quality System / Good Manufacturing Practice Regulations experience span over 30 years. Areas of expertise include microbial contamination and control; microbial specifications for non-sterile and sterile dosage forms; drug substance, excipient, in-process and finished product microbiological method suitability and testing requirements; release and stability requirements and testing; sterility assurance and aseptic processing, down-stream / purification process contamination and control strategies for biotechnology products; disinfectant qualification; water system and environmental validation; and compounding pharmacy regulations and microbiology-related requirements. He has presented seminars and workshops domestically and internationally on theory of microbiology testing, including training for FDA CDER and CBER branches.

    Abstract
    Due to unforeseen circumstances, this webinar has been postponed to a further date.
     
    Safety and efficacy are the two regulatory benchmarks for pharmaceutical products. Microbial contamination of products is an important aspect of product quality that can affect both safety and efficacy. The presence of microorganisms in sterile products or objectionable organisms in non-sterile products may impair safety of the products especially in vulnerable populations. Product efficacy may be impaired by microbial growth and byproducts leading to degradation of active components or other changes in formulations that may lessen product effectiveness. Suitable controls are built into materials and manufacturing practices to prevent or mitigate microbial contamination. Monitoring of materials and controls forms the basis of the Quality Control program to provide continued vigilance to assess the effectiveness of microbial controls. For non-sterile products, elements of microbial control should be built into the product during product development. For sterile products, the means of sterilization or aseptic processing form the basis of eliminating viable microorganisms to provide a suitable sterility assurance level. Product and process validation provide meaningful evidence of the ability to produce products that meet microbial specifications. Microbial testing is an adjunct that provides a point-in-time assessment of the product and process controls. Testing by itself cannot provide assurance but may alert the organization that controls are failing or have failed.
     
    This presentation will consider the role of microbiology and microbial testing during product development, stability testing, process and product qualification, and commercialization. Microbial testing and testing strategies to assess pharmaceutical ingredients, in-process quality, and finished product microbial compliance with microbial specifications will be discussed
     
    Learning Objectives:
    • To understand the role of Microbiology throughout the product life-cycle.
    • To become familiar with the essential elements of microbiological method verification and validation, and when to apply each.
    • To comprehend the limitations and strengths of microbial testing; what the data tells you and what it cannot tell you.
    • To assess the role of microbiology data in alerting the company to processes drifting from a state of control and when to take action.
     
     
    Webinars will be available for unlimited on-demand viewing after live event.
     
    LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.

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