Datwyler

For anyone involved in packaging injectable drug products, understanding and addressing particulate matter is of utmost importance. Join us for a webinar that will delve deep into the world of particulate categorizations, considerations, and compendia, ensuring alignment with relevant regulatory bodies.

https://www.pharmtech.com/pt_w/particulate-matters

Particulate matter, as defined by the USP, refers to the presence of mobile undissolved particles in solutions, excluding gas bubbles. It is a critical aspect to consider for those involved in packaging injectable drug products, requiring a thorough understanding, mitigation, and adherence to regulatory standards. During this exclusive webinar, experts will delve into the fundamental aspects of categorizing, considering, and complying with particulate matter.

Understand the various categories of particulate and how they are classified and monitored by regulatory authorities

Understand the risks and challenges injectable drug developers and their packaging suppliers must consider regarding particulate

Learn best practices for how to mitigate particulate in pharmaceutical packaging manufacturing and supply

Quality/regulatory personnel in parenteral drug delivery

Formulation scientists and packaging engineers

Device development engineers and managers

Technical functions surrounding drug delivery systems

 attended college at Widener University. In that time, she earned both a Bachelor’s and Master’s degree in Biomedical Engineering, graduating with honors. In May of 2019, she entered the pharmaceutical packaging industry in a technical, customer-facing role, recommending and evaluating packaging components for major drug companies.
Since then, Gabrielle has worked in multiple customer-facing technical roles at two of the leading pharmaceutical packaging companies in the world. Through COVID-19 and the aftermath, she has supported major biologics, generics, and pharma companies to provide high-quality products to their patients. Gabrielle currently serves as a Technical and Scientific Expert on Datwyler's Technical and Scientific Support team.


Webcasts

Webinar Date/Time: Wed, Mar 6, 2024 10:00 AM EST




Particulate Matters: Categorizations, Considerations, and Compendia

This webcast aims to highlight the considerable evolution that was made with regards to chemical cleanliness of rubber components and their impact on extractables and leachables.

https://www.pharmtech.com/pt_w/lockdown-lessons

During the COVID-19 pandemic, supply chains around the world were disrupted, especially those in the pharmaceutical industry with the critical task of delivering life-saving vaccines worldwide. Three years after the start of the pandemic, the industry has learned valuable lessons for how to de-risk the supply chain and prepare for future emergent scenarios.
In this webcast, the audience will learn how COVID-19 impacted the pharmaceutical industry and drug supply, how to mitigate risk in the future, and how to create a future-proof supply chain that will prepare the industry for what comes next.


Understand the impact COVID-19 had on global supply chains and reactions from the industry.

Learn ways to mitigate risk to global supply chains for future emergent scenarios.

Understand how the industry can learn from recent disruptions to develop strategic supply chain solutions.

attended Widener University. In that time, she earned both a bachelor’s and master’s degree in biomedical engineering, graduating with honors. In May of 2019, she entered the pharmaceutical packaging industry in a technical customer service role, recommending and evaluating packaging components for major drug companies. Less than a year later, the COVID-19 pandemic began, and Gabrielle saw first-hand how supply chain disruptions were affecting both companies and patients.

In 2022, Gabrielle joined Datwyler’s Technical and Scientific Support team as a Scientific Support Manager, serving customers in the North American region and globally. With a current focus on biologics, biotech, and cell and gene therapy, Gabrielle helps her clients find the perfect packaging solutions for their specialized drug products.

Webinar Date/Time: Tue, Jul 25, 2023 9:00 AM EDT

Post-COVID Supply Chains: Lockdown Lessons Learned

This webcast aims to highlight the considerable evolution that was made regarding chemical cleanliness of rubber components and their impact on extractables and leachables.

Rubber components are often an essential part of the primary packaging system of parenteral drugs. This webcast aims to highlight the considerable evolution that was made regarding chemical cleanliness of rubber components and their impact on extractables and leachables. This webcast will also address the two main coating technology standards, spray and film coating, and their common characteristics as well as their unique features and benefits.

Understand the basics of pharmaceutical rubber formulations and their composition.

Learn what aspects of rubber compounding affect the chemical cleanliness of the closure—and, ultimately, the drug quality—and the challenges closure manufacturers must overcome to guarantee patient safety.

Understand the different coating technologies that further improve extractable and leachable profiles, their common characteristics, and their unique features and advantages depending on the specific situation.


Global Platform Leader, Vial Closures
Datwyler


 holds a degree in Public Administration. After working in the human resources domain, he joined Datwyler in 2007. Geert has over a decade of experience within Datwyler as a Key Account Manager and is responsible for various strategic pharmaceutical accounts throughout Europe and beyond. In this role, he has developed a thorough insight in the landscape of pharmaceutical parenteral packaging components. In 2018, Geert became the strategic lead of Datwyler’s vial closure system components as a Global Platform Leader and drives the product and service portfolio, as well as product and service innovations, and formulates the market approach.

Webinar Date/Time: Thu, Jun 22, 2023 9:00 AM EDT

Ultra-low Extractable Formulations and Beyond: Different Coating Technologies and Their Unique Benefits

In this webcast, experts will inform the audience about the leading sterilization practices for parenteral packaging, explore scenarios to determine preferred sterilization techniques, and discuss the overall benefits to the pharmaceutical industry and, ultimately, the patient.

https://www.pharmtech.com/pt_w/sterilization-techniques

With regulations becoming stricter and patient safety at top of mind, industry leaders in parenteral packaging are continuously looking for the most suitable way to sterilize components and ensure product quality, reduce cost of ownership, and improve patient safety.
As natural resources become limited for certain sterilization practices such as gamma radiation, more sustainable options, such as steam sterilization, are becoming alternative solutions for packaging providers.
Not only does the effect of the sterilization process used on the products require consideration, but between all existing methods, it is important the find the most fit-for-purpose technique that aligns with client expectations.
In this webcast, experts will discuss leading sterilization practices for parenteral packaging, explore scenarios to determine preferred sterilization techniques, and examine the overall benefits to the pharmaceutical industry and, ultimately, the patient.


Learn the leading sterilization techniques for parenteral packaging components.

Recognize the benefits for each technique and potential challenges.

Understand the benefits of specific sterilization practices for the end user.


Head of Global Process Engineering
Datwyler

Tom Lenaerts joined Datwyler in 2017 and has held the positions of Production Manager, Datwyler Production System Manager, and Process and Validation Manager in the Belgian plant before taking up the position of Head of Global Process Engineering. Before joining the Datwyler organization, Tom worked for 14 years within an engineering and consultancy firm. Tom also has a master’s degree in industrial engineering.




Global Process Engineer, Sterilization
Datwyler

Anneleen Lodewijks graduated with a master’s degree in bioscience and joined Datwyler in 2020 as a Quality Assurance Officer in the Belgian plant. Previously, she gained experience in the pharma industry as Continuous Improvement Officer at a pharmaceutical packaging company. In October 2021, she took over the role as Global Process Engineer, Sterilization.

Webinar Date/Time: Tue, May 16, 2023 9:00 AM EDT

Advantages and Challenges of Sterilization Techniques for Parenteral Packaging

Prefilled syringes are an ideal drug delivery system due to easier administration, reduced risk of contamination, minimized risk of injuries during use and improved accuracy. In this webcast, learn why it is critical to ensure that prefilled syringes are designed to be patient-friendly and meet the regulatory guidelines.

Prefilled syringes (PFS) are effective drug-delivery systems that are patient-friendly and conserve drug product. Though these systems offer clear advantages as a drug delivery platform, their designation as combination products offer additional regulatory challenges. As a combination product, the mechanical functionality of the syringe-elastomer system is an important consideration. An element to consider is the break-loose force (BL) and gliding force (GF) profile.
In this webcast, the importance of a patient-appropriate BL & GF profile and the importance of optimization for efficacious drug-delivery will be discussed, in addition to:

Force exertion considerations for different patient populations

Strategies for elastomer selection to optimize BL&GF profiles for consistent performance

Know the challenges faced by pharmaceutical companies when producing a PFS system

Understand how the interplay between elastomer, barrel, and silicone impacts functional behavior like the BLF & GF

Gain insight into interactions at the elastomer/ barrel interface and discuss elastomeric options that can help to improve consistency with BLF & GF curve

 graduated with a B.S. degree in Biomedical Engineering from Drexel University in Philadelphia, PA. After finishing her undergraduate studies, she joined West Pharmaceutical Services where she served in several technical roles. In 2021 Katie graduated with her M.S.E. in Bioengineering from the University of Pennsylvania in Philadelphia. Katie has focused both her career and educational pursuits around primary parenteral packaging systems from research and development to implementation in medical devices to scientific consultation to support commercialization. Katie joined Datwyler in 2021 as a Scientific Support Manager. She collaborates with pharmaceutical companies in the selection of parenteral packaging solutions for safe and efficacious drug-delivery.

Webinar Date/Time: Mon, Jan 23, 2023 10:00 AM EST


Understanding Break-loose & Glide Force Behavior in Prefilled Syringe Systems

https://www.pharmtech.com/pt_w/smartgoals

As a sector, the pharmaceutical industry’s carbon emissions are even greater than that of the automotive industry - in the region of 55% more emission intensive. Drug delivery devices and the primary and secondary packaging account for a proportion of the CO2 emissions of combination products based on their design. The urgency of action required for global GHG emissions reduction means that parenteral packaging suppliers cannot work in isolation if they are to reach these GHG reduction goals. The Alliance to Zero was established to directly address this issue, by adopting the principles of the circular economy to facilitate the transition of the pharma sector to net zero emissions by 2030. This webcast will introduce the ambition of the Alliance of Zero, explain the methodology and impact the association intends to have and how pharma suppliers can participate.

Understand the objectives of the Alliance to Zero, as a membership association for pharma supply chain organizations.

Learn more about what a net zero emission concept for pharmaceutical manufacturing and supply chain would look like and the steps necessary to achieve it.

Understand how pharma suppliers can participate in the alliance and share the common goals to contribute directly to the reduction the scope 3 emissions for pharma clients.


Innovation & Business Development Manager
Ypsomed

Sebastian Gerner is Innovation & Business Development Manager with Ypsomed Delivery Systems. He is driving the transition of Ypsomed from a linear take – make – waste economy towards a circular economy. He is a mechanical engineer with more than 10 years of medical device experience in various medical and pharmaceutical companies.


Head of Sustainability and Agility
Datwyler


Sabrina Gérard is Head of Sustainability & Agility at Datwyler. She is a chemical engineer with more than 25 years of experience in lean & agile, sustainability and quality assurance. She has been working for global fast growing organisations in the automotive, medical device and healthcare industries. As Head of Sustainability she coordinates sustainability programs together with employees, customers, and society.

Alexander Schäfer joined Sharp’s European Business Development team in 2014 as Business Development Manager. Before joining the Sharp team, Alexander worked during the last 20 years for a number of CMO’s/CDMO’s such as Catalent and NextPharma in different Sales & Marketing related roles covering clinical and commercial manufacturing and packaging services.


Head of Product Management Packaging Machines
Körber Pharma

Manuel Huber is Head of Product Management Packaging Machines with Körber’s Business Area Pharma. He joined Körber in 2013 and since acquired an extensive knowledge of secondary packaging solutions and machines for any kind of parenteral products and devices and build up a deep insight of the international pharma and biotech market. He graduated with a degree in Mechanical Engineering and holds an additional degree in Business Administration.

Wednesday, December 8, 2021 at 10am EST | 7am PST | 4pm CET | 3pm GMT

How can the pharma packaging supply chain collaborate to make a significant contribution to GHG emissions reduction goals?  Join the webcast on December 8th to learn what a net zero emission concept for pharmaceutical manufacturing and supply chain would look like, and the steps necessary to achieve it.

Datwyler

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