Webinar Lunch and Learn
The past months have brought a sea of change to many of our daily lives as the impact of the continued spread of the novel coronavirus SARS-CoV-2 [Covid-19] has altered how we work, where we work and how we recreate, as communities around the world attempt to slow its spread and flatten the curve. ISPE DVC has organized this webinar series to provide an opportunity for our membership to earn PDH credits due to the cancelling of our in person events.
Three separate webinars will be offered to cover a variety of educational topics and will provide each member with 1 PDH credit per webinar. The sessions will address the following topics:
1. Cost Analysis: Outsourcing vs. In-House Bioprocessing Operations (scheduled for July 22)
- The economics of “Make vs. Buy” is a common exercise done by biopharma companies when deciding whether to build out their own manufacturing capabilities or to partner with contract manufacturer. In this session.
- Tia Lyles-Williams, Founder & CEO of LucasPye BIO, will discuss the Total Costs for Outsourcing vs. In-House Bioprocessing Facilities. LucasPye BIO is a Biologics CDMO based in Philadelphia, PA. LucasPye BIO is operating in collaboration with Jefferson Institute for Bioprocessing (JIB) and Celltheon Corporation. They currently offer bio-development services and are preparing to build a 60,000 Sq. Ft. Large-Scale Bioprocessing Facility.
2. The Journey of Data Integrity (scheduled for July 29)
- This webinar will address the compliance expectations associated with the term “data integrity” from a perspective of the past, the present and into the future. What is the guidance from regulators, what does it mean, and what are some processes and approaches to bring your organization to an improved state of compliance?
- These and other questions will be addressed by Chad Wachter, Director of Product Quality and Compliance at GlaxoSmithKline’s Biopharmaceutical R&D operations.
3. What Time Is It? It's FO Equivalent Time! (scheduled for August 5)
- Presented by Samantha Kay of Fedagari Technologies, Inc., this lunch and learn will focus on understanding F0 equivalent time to achieve lethality for materials that cannot be sterilized at 121 C. Focus will be on calculating equivalent time and how to use F0. Additional session agenda will be provided in follow up session reminders.
Speakers:
Tia Lyles-Williams
Founder & CEO, LucasPye BIO
Tia Lyles-Williams is the first African-American Queer Woman to own/lead a Biologics CDMO. Tia has nearly 20 years of experience working in the biotech/biopharma industry, including a former employee of Big Pharma, i.e. Amgen, GSK, Baxter & Lonza. She has a well-rounded foundation of knowledge & experience with Large-Scale Bioprocessing Ops, Process Development & Scale-Up Ops., Bioprocessing Facility Design and Global Regulatory Affairs. Tia is an alum of Howard University (B.Sc. – Biology), Full Sail University (M.Sc. – Entertainment Business), and University of Southern California (MRSc. – Regulatory Science).
Chad Wachter
Director, Product Quality & Compliance for Biopharmaceutical R&D, GlaxoSmithKline
Samantha Kay
Research and Development Lead, Fedegari Technologies, Inc.
Samantha organizes training at the US facility located outside of Philadelphia, Pennsylvania. The facility is designed for customer collaborations and developing a deeper understanding of the Fedegari equipment and technology. Samantha specializes in cycle development activities for moist heat sterilization autoclaves, as well as hydrogen peroxide decontamination units and isolators. She received a B.S. in Biology from Lehigh University.
Registration Information:
|
COST |
|
|---|---|
|
All 3 Webinars in the Series (July 22, July 29, August 5) |
$45 |
|
All 3 Webinars in the Series - Non-Member (July 22, July 29, August 5) |
$75 |
|
The Journey of Data Integrity - ISPE Member |
$20 |
|
The Journey of Data Integrity - Non-Member |
$30 |