May 12, 2020
ISPE-CaSA Weekly Update
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Still Time to Register for Women in Pharma
Virtual Lunch & Learn May 14
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Women In Pharma will host a virtual Lunch and Learn on May 14 from Noon to 1 pm, EDT.
The discussion will focus on the changes in our work environment and dealing with burnout during Covid-19. We will also discuss how to find opportunities for leadership and individual growth.
HOW ARE YOU THRIVING IN THE CHAOS OF COVID-19?
As the lines between our personal and professional lives blur like never before, you should take burnout seriously and explore what you can do to ensure you are finding a balance that works for you. As you also experience changes to your work environment, how are you leading in this time of change? How are you showing up as a leader and how can you cultivate a role model mindset in this challenging time?
Join us for the first part of a series of topics to help you navigate times like this:
Session 1 will cover:
- Take burnout seriously- what you can do to prevent it during the COVID19 crisis?
- Cultivating a Role Model Mindset during incredible change is hard- Steps to help you build your leadership muscle.
Presenters are
Siobhan Ashmore,
Senior Consultant with Medical Engineering Consultants, Ft. Lauderdale, FL and
Tracy Eames
of Raleigh-Durham, founder of TEAMES & CO
.
Visit ISPE-CaSA's
website
for information about the speakers.
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ISPE-CaSA Call for Nominations for Executive Board and Committee Chairs
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Do you know someone who would be a great leader?
ISPE-CaSA is issuing its
annual call for nominations
for a variety of Executive Board and Board of Directors positions, including committee chairs.
The following positions are open: President, Vice President, Secretary, Treasurer. Also open are the following committee chairs: Education, Membership, Networking, YP/Students and IT/Social Media.
The Executive Board members serve one-year terms, and the Committee Chairs serve two-year terms.
Please nominate someone you know or nominate yourself using this form and and send it to
nominations@ispecasa.org
.
Deadline is May 22.
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ISPE-CaSA presents the first in a series of webinars on June 3 from 1:00 - 2:30 p.m. This webinar is sponsored by
DPS
and
Jacobs
.
Applying Innovative PM Principles in Accelerating Cell and Gene Therapy Programs
By Michael Gorman, PMP, LSSBB, Principal Consultant
Presentation Summary:
Uncertainty and complexity present innovators with countless challenges in developing early-stage cell and gene therapy programs. With a “patient, product, process” mindset, companies must navigate countless trade-offs to deliver safe and efficacious therapies appropriate for the product lifecycle stage. This presentation will discuss program management approaches seeking to find effective, harmonious solutions utilizing both traditional “left to right” milestone-based planning & controls with flexible, agile principles which foster innovation and enable flourishing through the expected unexpected.
Application of the FDA Guidance to Process Validation
By Ramesh Maragh, Lead Technical Consultant, DPS Group
Presentation Summary:
This presentation will focus on application of the 2011 Process Validation Guidance and its importance to manufacturing cell and gene therapies. It will draw in a case study on its relevance to the Life Science industry and show the inter-dependencies of the complex regulatory compliance, process develop and life-cycle management relationships.
Thanks to our generous sponsors for your support.
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Technology Life Sciences Conference News
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Memories of 2020 Tech Conference: Photos Online
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ISPE-CaSA has almost 1,000 photos from the 2020 Technology Life Sciences Conference March 10 in Durham. From the Opening General Session and Keynote Address, to the Expo, Raffle and Reception, visit our
online photo album
and relive the memories of a great conference. We look forward to seeing you next year!
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Make Your Deposit for ISPE-CaSA's
28th Annual Tech Conference in 2021
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Staying Connected and Educated Through ISPE
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ISPE-CaSA Members Save 15% on Fees for Manufacturing Conference & Continuous Manufacturing Workshop
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I
SPE continues to monitor the unfolding global impact of COVID-19, and as the world evolves, so does our industry.
Therefore, the 2020 Biopharmaceutical Manufacturing Conference, June 1-2, and the Continous Manufacturing Workshop, June 3-4, will be fully digital.
ISPE has arranged an exclusive rate for the ISPE Carolina-South Atlantic Chapter. To save 15% off your registration fee, just use promo code
SAVE15%
by
May 18
o
n the combined conference and workshop
Featured speakers are:
Wilson W. Bryan, M.D.
, Director, Office of Tissues and Advanced Therapies, FDA;
Lawrence A. Hill, PharmD, MBA
, CEO, Gan & Lee Pharmaceuticals USA;
Maria L. Hoffman
, Executive Director, Engineering, Merck & Co Inc.,
Carol Lynch
, President, Sandoz US, Head, North America Head, North America, Sandoz US Inc.
2020 Continuous Manufacturing Virtual Workshop:
We continue to monitor the unfolding global impact of COVID-19, and as the world evolves, so do we. We are transforming this event to be fully digital:
The 2020 ISPE Continuous Manufacturing Virtual Workshop June 3-4.
- Explore two tracks on continuous manufacturing for large molecules – drug substance, and continuous manufacturing for small molecules – drug product, drug substance, and API
- Identify the supply chain, safety, and quality assurance advantages provided by continuous manufacturing
- Learn about the different approaches to continuous manufacturing regarding equipment, measurement tools, and control strategies
- Analyze avenues for enhanced communication with regulators on innovative and emerging technologies
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Annual Golf Tournament Postponed
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POSTPONED: NEW DATE TBD
ISPE 26th Annual Golf Tournament
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Due to the uncertainty of closures due to COVID-19, the 26th Annual Golf Tournament will be postponed and a new date will be announced as soon as possible.
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Partnership & Spons
orship Opportunities
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2020 Education Sponsorships Support Seminars and Workshops for ISPE-CaSA
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Support from industry partners is crucial to the success of ISPE CaSA education events. These events serve as a platform for collaboration of best practices among peers as well as a conduit to deliver emerging industry knowledge. ISPE CaSA is offering an opportunity to become a valued sponsor for the 2020 program year.
Each of the four themed education session sponsorships costs $1,000 and comes with its own unique set of benefits.
YP and Student education sponsorships are available for $200 each.
Your sponsorship will also extend your company's brand throughout our marketplace and provide a valuable benefit to our organization.
Email
info@ispecasa.org
to find out how to support our education events. Visit ISPE-CaSA's website and head over to our sponsorship
form
to learn more.
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Therapeutic Thursday Sponsorship
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Sponsorship opportunities are available for our popular Therapeutic Thursday events outside the RTP area.
Email
info@ispecasa.org
if you would like to sponsor a Therapeutic Thursday in your state.
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