Webinars

Although many aspects of integrated CQV programs could be covered by current policies, most organizations can benefit from additional program review and development. Including sufficient procedures and templates can streamline and enhance the process of document development, reviews/approvals, timing of inter-related activities, and overall CQV leveraging strategy.

An integrated CQV strategy can support current projects and ongoing operations. This webinar will cover integration strategies in several key areas, including:

1. General Validation Strategy Program Development
2. Validation Program Governance
3. Change Management Procedures
4. Additional Programs:

• CQV Organizational Structure and Resource Requirements
• CQV Communication Plan
• Schedule Logic Development
• CQV Execution Tracking Tools
• Cost Management
• CQV Issues Log, Submittal Log, and RFI Log
• Project Management and Project Controls Program Development

• Michael Bogan - President, ICQ Consultants
• Michael Gatta - Princiapl, ICQ Consultants

WATCH NOW ON-DEMAND

Avéma Pharma Solutions, a division of PL Developments (PLD), is in the unique position being both a consumer and supplier of global CDMO services for both OTC and rX products. In this webinar, we’ll explore the lessons we have learned from managing our own CMOs that have allowed us to build a better CDMO model for our Avéma customers. We’ll address the areas that can help speed up your time-to-market, keep development costs under control, and smooth the FDA approval and commercial launch process.

Over the years, PLD has used CMOs to augment our own in-house manufacturing to help support our Private Label business. But, after adding a book of products and business from our acquisition of TEVA’s store brands business in 2019 we were suddenly managing the more than thirty CMOs that supported TEVA’s needs. That process, plus our experience on-boarding new customers at Avéma, has given us empathy about the challenges and insights into what makes a good partnership. The webinar will cover what to look for in a CDMO, and how putting the right parameters in place at the beginning of a client-CDMO relationship, reduces risk and improves communications.

Some of the “pain points” addressed during the webinar, include:

• Preventing miscommunications and errors through a detailed RFQ process
• Reducing scale up errors by using small scale manufacturing instead of “bench top” equipment.
• Reducing cost and time by not having to rely on commercial size equipment “scaled down” to run pilot trials.
• Reducing lead time by doing most analytical and tech transfer with “in house” resources
• Keeping component costs down by drawing on the buying power and resources of a CDMO with an extensive network.
• Streamlining FDA approvals through QbD implementation.

• Jeffrey Speicher - Commercial General Manager, Avéma Pharma Solutions
• Dana Toops - President, Avéma Pharma Solutions

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Scientists are the literal lifeblood of new product development and innovation, but they often spend much of their time simply pulling together data to conduct analysis in hopes of key learnings. The biggest lever that R&D leaders have today is to implement tools that make this learning process faster and easier, through better data tools. This Webinar will focus on the benefits of implementing a true data infrastructure, and the challenges that organizations will face along this journey.

• Identifying where on the digitalization journey your R&D organization is
• What is meant by "structured data capture"
• The steps necessary to implement a structured data solution successfully, and common pitfalls
• The short term and long term benefits of a truly connected R&D team

WATCH NOW ON-DEMAND

Whether you are an emerging CDMO looking to scale rapidly and attract sponsors or an established organization looking to transform your legacy quality manufacturing processes there is an approach to consider.

Join Veeva System’s Ashley Wentworth, Director of Quality Strategy and Glen DeGuzman, Solution Consultant, to learn how you can unify end-to-end quality management to improve visibility, efficiency, and compliance.

Why should I attend?

See how a unified cloud solution purpose-built for life sciences allows you to:

• Seamlessly connect processes, data, content, and training
• Improve on-site and remote audit responsiveness and readiness
• Securely collaborate with external customers, suppliers, and partners

Register to see how your organization can drive speed, collaboration, and GxP compliance.

Presenters:

• Ashley Wentworth - Director, Vault Quality, Veeva Systems
• Glen DeGuzman - Solutions Consultant, Veeva Systems

WATCH NOW ON DEMAND

Join James Scull, Ph.D., Scientific Director for Element Life Sciences, for a live webinar to gain a deeper understanding of extractables and leachables (E&L) evaluations of custom drug delivery devices. Dr. Scull will present a case study that explores the E&L consideration of such custom delivery systems in order to meet regulatory requirements.

Why should I attend?

Dr. James Scull discusses extractables and leachables testing considerations for customized syringe delivery systems. His presentation will include:

• An overview of regulatory requirements for drug delivery systems
• Situations and types of drug delivery devices requiring custom E&L testing solutions
• When during the development journey such testing should occur
• Other factors to consider when determining when the E&L evaluation is necessary

WATCH NOW ON DEMAND
 

Each phase of drug development encounters specific hurdles that require specialized expertise and advanced technologies to overcome and to ensure readiness for the next phase. A holistic approach to a program with cohesive program management can offer a dedicated focus to the intricacies of each phase and beyond. In this webinar, Catalent experts will explain how the phase appropriate expertise and technologies of the OneXpress™ Solution can help streamline development and manufacturing, speed up your program timelines, and reduce risks to transform your science into a successful treatment.

Key Takeaways:

• The nuances and complexities of early versus late stage development
• Top considerations for a robust formulation and manufacturing strategy
• The need for fully integrated CDMOs and the advantages of the OneXpress Solution

WATCH NOW ON DEMAND

Inductively Coupled Plasma - Optical Emission Spectrometry (ICP-OES) and Inductively Coupled Plasma - Mass Spectrometry (ICP-MS) are widely applied in pharmaceutical analysis, including drug product analysis and medical device analysis. ICP-MS is commonly used for elemental impurities analysis and extractable/ leachable studies due to its high sensitivity. The evaluation of individual elements is based on USP 232 and ICH Q3D guidelines. Additional elements that are not included in the risk assessment per ICH Q3D can also be quantified. ICP-OES has been found to be a powerful tool in reverse engineering of a Reference Listed Drug (RLD). For those active pharmaceutical ingredients (APIs) containing metal elements, such as iron, zinc, arsenic, sodium, platinum, ICP-OES can be used to accurately quantitate these elements in the APIs and finished drug products.

• Introduction on ICP-OES and ICP-MS, their sameness and difference
• General Application of ICP-MS
• General Application of ICP-OES
• Sample Preparation for ICP analysis: Microwave digestion system, CEM MARS 6

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The classical approach to bioavailability enhancement of poorly water soluble drugs is through the use of solubility enhancers such as co-solvents, surfactants, and emulsifying agents. But depending on the rate limiting factors for drug absorption, simply increasing the API solubility may not have a significant impact on the bioavailability. There is an interplay between solubility and permeability that can be evaluated using In vitro flux/permeability testing. This can provide valuable insight into the potential factors limiting bioavailability, and should be characterized before choosing a bioavailability enhancing formulation approach. This approach can also be used to compare release and absorption of candidate formulations. 

In this webinar we will discuss the use of in vitro flux and permeability as a tool in formulation development to:

• Evaluate/characterize the rate limiting factor(s) for passive diffusion of an API.
• Screen potential bioavailability enhancers for improvements to flux and permeability.
• Compare candidate formulations for potential bioavailability enhancement.

SPEAKER:

Travis Webb, MS Pharmaceutical Chemistry

Formulation Scientist, CoreRx, Inc.

WATCH NOW ON DEMAND

Are you wondering how to set up a stability test plan for your vial product?  Are you confused at all the options for Container Closure Integrity Testing and wondering how to decide which one to choose for your product?  Then join us for a webinar on Stability and CCI testing.  We will outline the basics for setting up a stability test plan for rigid containers including aging conditions and testing frequency.  We will look at how probabilistic methods differ from deterministic methods and will discuss each of the common CCI test options outlined in USP 1207.  We will conclude with CCI method validation basics.

Agenda:
 

• Stability Testing Basics
• Probabilistic vs. Deterministic Test Methods for CCIT
• Important Considerations for CCI Testing
• CCI Test Method Validation Basics

Presenter: 
 

Jennifer Gygi, B.S., SM(NRCM)
Expert Technical Consultant, Nelson Labs

• Acceleration of bench-to-bedside timelines in oncology
• Emergence of decentralized trials
• Impact of decentralized trials on regulatory pathways
• Real-world evidence’s influence on future trial design

• Bruce A. Feinberg, DO- VP of Clinical Affairs and Chief Medical Officer, Cardinal Health Specialty Solutions
• Todd Phillips, PharmD– Director of Regulatory Affairs, Cardinal Health Regulatory Sciences
• Scott Swain, PhD, MPH– Director of Real-World Evidence and Regulatory, Cardinal Health Specialty Solutions

WATCH NOW ON DEMAND

Univercells Technologies has been working to leverage deep expertise in bioprocessing and equipment development to revolutionize virus manufacturing for gene therapy and vaccine production. By combining the principles of intensification and chaining, the company has introduced the NevoLine™ Upstream platform, a fully automated and integrated biomanufacturing unit designed to enable commercial scale capacity in a compact module. 

Directly from its development site in Belgium, Univercells Technologies is inviting you to join the virtual product launch of this breakthrough technology. The event will highlight the features of the NevoLine Upstream platform, including an explanation of the main benefits and key performance data. Attendees will see how users of the NevoLine Upstream platform can increase viral productivity while benefiting from a flexible process approach in a reduced footprint.

The event will offer: 
 

• A review of the principles of intensification and chaining and how they directly influence viral performance, manufacturing footprint, and overall costs
• A demonstration of how the NevoLine Upstream platform enables commercial upstream and midstream GMP manufacturing in a 3m2 (~32 ft2) footprint
• A look at how the design of the NevoLine Upstream platform aligns flexibility and productivity to accommodate various process configurations
• A comparison of footprint, Capital Expenditure, and Cost of Goods gains using the NevoLine Upstream platform versus conventional technologies

WATCH NOW ON-DEMAND

Learning Objectives

• Discover a new implementation of packaging for the safe transport of high potency and/or sterile ingredients between DS production and DP formulation facilities. 
• Learn how disposable containment technology can change the status quo and provide additional benefits to both CMO’s and end-users / product owners alike.
• Gain insight in to how these technologies have been validated to meet the needs of primary packaging, sterility assurance and powder containment.

Who is it for:

• Pharmaceutical companies with CMO partners looking to deploy faster off the shelf solutions that can be utilised throughout their in-house and extended networks.
• CMO’s and ingredients manufacturers looking for standardised packaging formats that add value and to their products and improve their customers convenience from goods receipt to processing methodologies.
• Supply chain partners responsible for managing CMO partnership and the associated value chain for receiving product.
• Packaging Engineers looking to discover and implement new packaging formats that can benefit their companies’ operations.
• Process and production Engineers who need to solve powder containment challenges during transfer to and handling within the production facility.
• Quality and Validation Engineers looking to solve sterility assurance challenges associated with packaging of product for storage and transportation and the transfer of powders for aseptic filling.

Speaker:
 

Ben Wylie

Senior Product Manager, ChargePoint Technology

• Approaches that may eliminate the need for dedicated production equipment and facilities, thus maintaining the benefits of outsourcing and efficiencies of scale.
• Advances in equipment and technology that will strengthen safety methods, while maintaining flexibility for multi-product plants.
• How the decisions CDMOs make today transform the way products in multi-product facilities will function together in the future.

• Steve Nole - Vice President, Operations, Grand River Aseptic Manufacturing
• Les Edwards, MSE - Vice President of Technology and Business Development, SKAN
• Andre Zdunczyk - Regional Business Development Director, USA, Bausch + Strobel

WATCH NOW ON-DEMAND

Are you developing a biologic, biosimilar, or other complex drug product requiring lyophilization? Register for this webinar from Lubrizol Life Science to explore key considerations in designing and executing aseptic process simulations for lyophilized products, including a deep dive into study design, operational considerations, and regulatory guidance. Learn how robust validation can lead to commercial manufacturing success.

Key Learning Objectives:

• Explore the growth of aseptic lyophilization for biologics and complex drug products
• Discuss validation requirements and regulatory guidance for aseptic manufacturing processes
• Explain aseptic process simulation (AKA media fill) design and execution for lyophilized products
• Investigate common challenges and solutions when performing aseptic lyophilization—including operational considerations and real-world examples
• Understand how a well-designed validation strategy enables efficient aseptic lyophilization for the long-term

Speakers:
 

Dr. Karen Bossert

Vice President of Operations, Lubrizol Life Science Health – CDMO Division

Judy Cohen

Vice President, Quality Assurance, Lubrizol Life Science Health – CDMO Division