Webinars

    ICH Stability Testing and Method Development

    ICH Stability Testing and Method Development

    04.22.20

    Wednesday, April 22nd, 2020 | 1:00 PM ET

    Stability testing is a vital part of product development and is conducted throughout a product’s life cycle. Stability is part of a biotherapeutic’s quality target product profile, and results help analysts understand how critical quality attributes (CQAs) of both drug substances and products are influenced under specific conditions of temperature, relative humidity (RH), light, storage, pH, and other factors. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. This presentation will provide a brief overview of the ICH guidelines for Stability testing, as well as aspects of analytical method development.

    Speaker:
     

    Shiri Hechter

    Chemistry Senior Lab Operation Manager, M.Sc., ASQ CQA and CSSGB

    Nelson Labs Fairfield
     

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    New Horizons in Formulation

    New Horizons in Formulation

    03.24.20

    Tuesday, March 24th, 2020 | 11:00 AM ET

    A Revolution in the Production of Mono-Dispersed Controlled Release Microparticles

    Are existing technologies fit-for-purpose in terms of quality, control, efficiency and throughput volumes for manufacturing complex 21st century therapeutics? A new generation of proven, energy efficient, high volume membrane emulsification equipment, promises to be a game-changer for contract pharma. In this webinar you will learn:

    • The enhanced therapeutic performance potential for emulsions, double emulsions and encapsulated particles in pharma applications with improved mono-dispersity;
    • Why membrane emulsification offers significant advantages over both traditional homogenization and microfluidic processing; and
    • Through specific case studies, how this new technology can significantly reduce or eliminate downstream processing steps with significant manufacturing savings.
    Speakers:
     
    Dr. James D. Oxley, Ph.D
    Southwest Research Institute (SwRI) in San Antonio, TX, USA.
     
    Sam Trotter MSc
    Operations Manager at Micropore Technologies Ltd.


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    Serialization 2.0 – What’s Next?

    Serialization 2.0 – What’s Next?

    02.12.20

    NOW AVAILABLE ON-DEMAND

    The road to serialization has been long and arduous for the pharmaceutical industry. Yet, there are still many hurdles to overcome in the next few years—saleable returns, line aggregation and interoperable data exchange just to name a few.

    Additionally, industry experts now realize that serialization alone will not solve the ever-increasing global threat of counterfeited and diverted pharmaceutical products. The investments made to date on serialization are staggering and pharmaceutical companies are now looking to leverage these efforts to more effectively fight their supply chain and compliance issues.

    Join us as we discuss the future of the pharmaceutical supply chain and review innovative technologies that will not only get us to the 2023 DSCSA deadline, but are changing the landscape for brand, product and consumer protection.

    In this webinar we will discuss:

    • Saleable Returns and VRS
    • Secure tracking at the package level, including aggregation
    • Why your drug distribution channel is still not safe
    • Augmenting existing serialization solutions with innovative technologies
    • Leveraging existing package labeling to fight supply chain threats
    • Cost-effective solutions to prevent counterfeiting and diversion
    Speakers:
    Steve Tallant, Senior Director, Market Development - Solution Marketing Group, Systech

    Sharp Packaging  - TBD
     
    Excellis Healthcare - TBD


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     Designing Auto-Injectors for Multiple Drug Viscosities

    Designing Auto-Injectors for Multiple Drug Viscosities

    11.26.19

    NOW AVAILABLE ON-DEMAND

    The global injectable drug delivery market and, more specifically, the auto-injector market is booming.  That growth is predicted to continue skyrocketing through the next decade.  With such a huge market in play, and given the range of physical properties of drugs and biologics being administered via auto-injectors, it is crucial for pharma and biopharma industry OEMs to optimize device designs to be as adaptable, and thereby as cost-effective, as possible.  Learn how to effectively partner with contract manufacturers and what design support they readily provide to you and your peers.

    SPEAKER: Dave Philbrick

    Dave Philbrick is Business Development Manager & Lead Product Engineer for Economy Spring, an MW Industries Company. For more than 38 years he has been involved in supporting new product development for medical instrumentation & drug delivery systems for Medical / Pharma OEM’s. He is a specialist in metal component development, design and integration.


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    Microbiological Control in a Pharmaceutical Manufacturing Environment

    Microbiological Control in a Pharmaceutical Manufacturing Environment

    10.29.19

    NOW AVAILABLE ON-DEMAND

    Part 1: Microbiological environmental monitoring data and establishment of alert and action levels
    This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data. We will review microbiological trending and how it can assist in understanding what is significant in each particular situation. The discussion will cover how the analysis of this trended data enables a company to establish alert and action levels as methods for determining these levels.

    Part 2: Pharmaceutical Environments Cleaning Validation Programs and Associated Disinfectant Studies
    We will review cleaning validation protocols, methods, and procedures to evaluate and define a robust program to protect your products, personnel, and equipment. We will discuss correlating disinfectant validations with the trending of routine-environmental monitoring data to establish a compliant program in a cleanroom environment.


    Part 3: Water Quality; Water Impurities, Purification Methods, Validation, and Process Controls
    Water is perhaps the most extensively used raw material in pharmaceutical manufacturing. Its use as an inactive ingredient, active pharmaceutical ingredient (API), analytical reagent, and even as a solvent in cleaning processes, leads to potential product and environmental contamination from residual water impurities. This presentation addresses the removal and control of microbiological and chemical impurities in a quality water system.


    Speakers:
    Martell Winters - Director- Scientific Competency
    Danina Rinaldi - Laboratory Technical Services Manager
    Paul Littley - Consulting Manager


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    Designing an End-to-End Sterility Assurance Program

    Designing an End-to-End Sterility Assurance Program

    07.25.19

    NOW AVAILABLE ON-DEMAND

    Sterility assurance for a pharmaceutical product is critical, and includes many aspects outside of the actual sterilization cycle or aseptic process. There is some recent movement in the health care industry regarding the term End-to-End Sterility Assurance, along with a document being written through AAMI to provide guidance on the topic. Effective sterility assurance includes extensive collaboration with parties across the product life cycle. In the webinar we will address the various aspects of sterility assurance and provide guidance on establishing a complete program.

    Speakers:
    Martell Winters - Director of Scientific Competency, Nelson Labs
    Wendy Wangsgard, PhD - Senior Scientist, Nelson Labs


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    Stability Testing as a Quality Control Measure

    Stability Testing as a Quality Control Measure

    06.25.19

    NOW AVAILABLE ON-DEMAND

    Optimizing the Process throughout the Product Lifecycle

    Assessing a compound’s stability is a complex and lengthy process with objectives varying by the development phase. A poorly designed stability study can cause delays that extend to years, create significant budget overruns and even result in product failure. Thus, stability testing requires scientific expertise and very specialized experience in order to minimize development costs and avoid severe consequences. This webinar will discuss the purpose, scope, and type of stability testing required at each phase of product development. With this understanding, sponsors can aim to optimize the process and ensure that the right data are gathered at the right time.

    SPEAKER:
    Guoqiang (Gary) Dong, PhD
    Executive Director of Analytical Services of CMC
    Frontage Laboratories


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    Terminal Sterilization or Aseptic Assembly? Consider all options for your Pharma product.

    Terminal Sterilization or Aseptic Assembly? Consider all options for your Pharma product.

    05.21.19

    NOW AVAILABLE ON-DEMAND

    Regulation is clear that, whenever possible, products intended to be sterile should be terminally sterilized in their final container. Only if terminal sterilization is not possible, filtration or aseptic assembly should be applied. This webinar will focus on elements to evaluate prior to selecting aseptic assembly for the manufacturing of sterile drug products. Participants will learn about various mitigation possibilities for the use of terminal sterilization with gamma radiation or ethylene oxide. Understanding the fundamental differences between aseptic assembly and terminal sterilization is a critical factor in overall patient safety.

    SPEAKER:
    Annick Gillet, Technical Director EO Pharma


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