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      ISPE-CaSA 2020 Webinar Series - Innovative Approaches Needed in Cell & Gene Therapy Production

      Add to Calendar ISPE-CaSA 2020 Education Webinar, Cell & Gene Therapy - June 3, 2020 ISPE-CaSA 2020 Webinar Series - Innovative Approaches Needed in Cell & Gene Therapy Production June 3, 2020 1:00 - 2:30 p.m. REGISTER HERE Applying Innovative PM Principles in Accelerating Cell and Gene Therapy Programs By Michael Gorman, PMP, LSSBB, Principal Consultant, DPS Group 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.   Michael Gorman has over 20 years’ experience in guiding life science companies in navigating a risk-managed, best-value path from pre-IND to commercialization. With balanced experience as both manufacturer and service-provider, Mike has directed multiple, diverse cross-functional teams through the technology transfer process.   At DPS, Mike helps clients develop strategy and systems for their technology transfer, CMC, manufacturing supply chain, and alliance management programs, so they can quickly and effectively deliver quality therapeutic products.  He works with DPS clients across a spectrum of technologies and modalities, with a focus in biologics – including both traditional and advanced therapeutic cell and gene therapies.   Application of the FDA Guidance to Process Validation By Ramesh Maragh, Lead Technical Consultant, DPS Group This presentation will focus on application of the 2011 Process Validation Guidance and its importance to manufacturing robus and compliant products. It will draw in a case study on its relevance to the Life Science industry and show the interdependencies of the complex regulatory compliance, process develop and life-cycle management relationships.    Ramesh Maragh is a passionate and dedicated engineer, scientist, and leader that models the way to define the current manner that highly scientific, technical, and regulated drug products are formulated, scaled, and optimized for routine commercial manufacturing including technology transfers. With over 20 years of industry experience Ramesh has worked within Analytical Research and Development, Manufacturing Science and Technology, Quality Assurance, and Operations with expertise in process development, optimization, validation (PPQ), and commercial product support (Deviation/CAPA management). Ramesh enjoys mentoring teams on application of compliance and science to produce the best medicines for the betterment of mankind. REGISTER HERE   Thank you to our sponsors!   . ., United States rcisneros@rickzebradesigns.com America/New_York public
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      WIP 6.10.2020 Image

       

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      Add to Calendar ISPE-CaSA 2020 Women in Pharma Webinar: Transform and Empower Yourself, June 10,2020     Sponsored by ISPE CaSA Women in Pharma invites you to join us for an interactive webinar focused on diversity, inclusive behaviors, and mentoring on June 10 from 10 a.m. until 1 p.m. (Eastern).   During this webinar you will: Better understand how to create an environment that is conducive to inclusive behaviors. Understand why diversity is a powerful force for improving decision making. Leave with more insight into how their own brains work thus improving your self-awareness and effectiveness. Learn about how to engage in local ISPE mentor circles   All industry professionals are welcome to attend: Anyone (female or male) interested in learning more about behaviors behind diversity and inclusion Anyone (female or male) interested in learning how to transform and empower yourself in your career Students and Young Professionals welcome Coaches ISPE Members ISPE Non-Members   Keynotes: “Are We Naturally Inclusive?" - John Daniel, Chief Human Resources Officer, First Horizon Financial Corporation "Transform and Empower Yourself" - Rebecca Holland New, Managing Partner, RSR Partner Solutions   Visit our registration site for more information and to register.           Webinar . ., United States rcisneros@rickzebradesigns.com America/New_York public
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      Add to Calendar ISPE-CaSA Women in Pharma - Virtual Lunch and Learn - June 16, 2020 JOIN US FOR Women in Pharma Lunch and Learn Webinar - Session 2 Tuersday, June 16, 2020 12:00pm to 1:00pm   REGISTER HERE   HOW ARE YOU THRIVING IN THE CHAOS OF COVID19?  As the lines between our personal and professional lives blur like never before, why you should take burnout seriously and what can you 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 second part of a series of topics to help you navigate times like this:  Session 2:  Leading through Change: As we look to the future, the "way we work" will be dramatically different than it was even a few months ago. Whether you are exploring new opportunities, taking on new responsibilities, or looking for ways to better support your teams, together we will explore concepts of individual and team leadership in times of change. Specifically, we will explore how as a leader you can: Take Inventory and Evaluate the challenges you are facing, as well as your team/organizational strengths, opportunities, and resources. Set a Strategy in a Changing Landscape with a toolkit for how you and your team can achieve your shared strategy, and tools for empowering your team's success. Encourage Continuous Improvement through the definition of clear metrics for success, and a plan for adjusting course as needed.  This month’s presenter:  Tracy Eames   Tracy Eames. With a passion for transformative projects, Tracy has dedicated her career to developing exceptional commercial organizations, launching new brands, and building empowered and engaged teams, both domestically and internationally. With leadership expertise across marketing, sales, and product development, she thrives in building  a culture of innovation and collaboration across teams to deliver memorable customer experiences. As founder of TEAMES & CO,  she works with organizations to develop their teams and scale their growth.   Tracy has deep experience across biotech, healthcare, and consumer products sectors. She has earned a Masters in Business Administration (MBA) from ESADE Business School (Barcelona, Spain),  a Masters in Public Health (MPH) from Oregon Health & Science University (Portland,OR), and is a certified change practitioner through PROSCI.    If you would like to sponsor a WIP event, please contact Jessica Cochran: jcochran@jacobswyper.com     Webinar . ., United States rcisneros@rickzebradesigns.com America/New_York public