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International Hack-a-thon
08:00am - 05:00pm Eastern - October 29, 2022
Separate Registration & Fee Required
International Hack-a-thon
08:00am - 01:00pm Eastern - October 30, 2022
Separate Registration & Fee Required
Workshop: CSA - The Next Steps for Better Compliance
08:00am - 12:00pm Eastern - October 30, 2022
Lorrie L. Vuolo-Schuessler, Senior Director Computer Systems Quality and Data Integrity, Syneos Health; Ken Shitamoto, Senior Director, IT, Gilead Sciences; Khaled Moussally, Executive Vice President Clients & Regulatory Relations, Compliance Group Inc; Joseph Franchetti, Managing Consultant, JAF Consulting Inc; Michael Rutherford, Executive Director, Computer Systems Quality & Data Integrity, Syneos Health; Petch Ashida Druar, Director, Computer Systems Quality and Data Integrity, Syneos Health; Charlie C. Wakeham, APAC GxP Compliance Manager, Waters Corporation

In this workshop, attendees will brainstorm efficiencies and improvements that can be gained through the application of Computer Software Assurance (CSA) and critical thinking within computerized system lifecycles. The workshop activities will examine:

  • What improvements can CSA and critical thinking bring to computerized system lifecycles and what fundamentals will remain unchanged?
  • How critical thinking can become inherent organizationally?
  • How to engage leadership, including the quality function, with CSA concepts?
  • What metrics and knowledge management practices can quantify and optimize the benefits of CSA in achieving and maintaining computerized systems as fit for intended use?
  • How supplier assessments and internal auditing practices need to evolve to maximize leveraging of prior activities?
  • What are the barriers to progress and how can they be overcome?

This workshop will contribute to industry understanding of critical thinking and CSA.

Workshop: Process Validation
09:00am - 12:00pm Eastern - October 30, 2022
Maurice B. Parlane, B Tech MIT, Principal/Director, New Wayz Consulting Ltd/CBE Pty Ltd; Tara Scherder, Principal, SynoloStats; Katherine Giacoletti, Principal Scientist, Merck & Co Inc
This workshop session will address selected hot topics within focused workgroups giving attendees the opportunity to participate in facilitated small group discussions. This format will allow attendees to share experiences or challenges and discuss tools and learnings with colleagues outside of their organization, but with similar interest/experience, bringing a wider understanding of these issues.

Topics/Issues/Challenges for discussion will include PV for products under accelerated development/breakthrough designation; PV for continuous manufacturing; PV applied to emerging/new technology and product platforms; as well as discussions of PV in regions other than US/EU. Drawing from the ISPE PV team, volunteer SMEs will lead the groups and facilitate sharing experiences and thoughts, providing an environment to discuss ideas and strategies to address particular challenges based on experience and knowledge.

Workshop: Aseptic Compliance Health Check
01:00pm - 04:00pm Eastern - October 30, 2022
Adam Kiefer, Director, Head of IG Manufacturing, Takeda; Brant Bulgarelli, SME – Drug Product Fill/Finish, Exyte

Join this hands-on workshop where you’ll be led by Pharma Industry hardened Operations experts in using various tools that make your compliance assessment methodology easy to follow and robust. Our instructors will draw on real life operational and quality expertise to highlight and guide you through the following three main areas:

1. How you can use a simple step by step processes to determine whether your legacy processes and facilities meet current and future cGMP requirements.
2. Upcoming Annex 1 Requirements – How you can prepare for the upcoming Annex 1 requirements now, using a robust process for preparing your facility for these future expectations.
3. Hot Topics and Recent Inspection Trends – What recently has come up in the latest inspections?

The goal of the workshop is to help individuals navigate through the complexities of what is important and what is not, and to harness the use of the tools.

Workshop: Career Connections - Develop Your Personal Brand
01:00pm - 04:00pm Eastern - October 30, 2022
Vivianne J. Arencibia, Vice President, Global Quality Systems and Compliance, Moderna; Kara Kirby, Founder, Insights Leadership Group; Phil Gerbyshak, LinkedIn Sales Trainer, Sr. Sales Enablement Program Manager, BambooHR
Presented by Women in Pharma®
Bring your electronic device (laptop preferred)

Phil Gerbyshak and Kara Kirby will be on site to lead a highly interactive session and hands-on workshop to level up your personal brand and LinkedIn profile.

Do you have a personal brand? Is it on purpose? Whether you like it or not, hiring managers and HR professionals judge you based on what they find - and don’t - from you online. Want to stand out from your peers and your competition so you can get hired for the job of your dreams?

In the first half of this workshop, you’ll discover how to pursue your leadership potential by overcoming the imposter syndrome, learning the skills to bring the best out of any team, and honing your communication skills.

In the second half of this workshop, you will translate what you have learned about yourself and your teams to further develop your personal brand. This immersive, hands-on workshop is designed to elevate your personal LinkedIn Profile to take it to the next level. Whether you are looking to build meaningful connections, expand your network, or stand out from the best, this workshop will show you tactics to level up your LinkedIn profile.

Phil Gerbyshak is a LinkedIn Sales Trainer, Sr. Sales Enablement Program Manager at BambooHR, and talk show host of ‘The Sales and Leadership Show’ on sales, leadership, and digital strategies. He has been doing custom LinkedIn training since 2010.

Kara Kirby is a leadership consultant and CEO of Insights Leadership group and podcast host of Pop! On Leadership. She works with companies worldwide to guide their pursuit of being the best places to work.

FOYA Reception, Dinner & Awards
07:00pm - 08:00pm Eastern - October 30, 2022
Separate Registration & Fee Required
13th Annual ISPE 5K Charity Run/Walk
06:00am - 07:30am Eastern - October 31, 2022
Separate Registration & Fee Required
Breakfast with the Exhibitors
07:30am - 08:30am Eastern - October 31, 2022

Opening Keynote Session
08:30am - 10:15am Eastern - October 31, 2022
Thomas B. Hartman, President and CEO, ISPE; Robert E. Perks, MSc, CEng, Regional Manager, Cognizant Life Sciences Manufacturing; Michael Rutherford, Executive Director, Computer Systems Quality & Data Integrity, Syneos Health; Michael Kopcha, Director, Office of Pharmaceutical Quality, FDA; Robert Weker, Principal, Weker Advisors LLC; Thomas Wozniewski, Global Manufacturing and Supply Officer, Takeda

Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains
08:30am - 10:15am Eastern - October 31, 2022
Michael Kopcha, Director, Office of Pharmaceutical Quality, FDA
Patients expect safe and effective medicine with every dose they take. Pharmaceutical quality is what gives patients confidence in their next dose of medicine, but is pharmaceutical quality just one thing? An array of pharmaceutical quality including product quality, process quality, and quality management is necessary to assure that quality issues will not keep a product from being available to patients and consumers--now or in the future. FDA’s initiatives aim to provide everyone with more confidence in their next dose of medicine.
A Cancer Veteran’s Remarkable Journey
08:30am - 10:15am Eastern - October 31, 2022
Robert Weker, Principal, Weker Advisors LLC

Every patient is unique. Every cancer journey is unique. As a three-time cancer ‘sur-thrivor,’ Rob and his family have faced the many challenges of this disease. 

Rob provides his insights on his journey(s) - including 

  • Participation in a clinical trial? 
  • Finding the best medical team? 
  • Work and financial implications? 

– and his ongoing efforts to amplify the patient voice to enable patients to make informed decisions throughout.

Future-proofing a Global TechOps Organization: The transformation of Global Manufacturing & Supply at Takeda
08:30am - 10:15am Eastern - October 31, 2022
Thomas Wozniewski, Global Manufacturing and Supply Officer, Takeda
Spanning more than 30 manufacturing sites across the globe, the manufacturing network of Takeda is not only geographically complex but also from a technology perspective: It comprises manufacturing sites for small molecules, biologics, plasma-derived therapies, cell & gene therapies and vaccines. This diverse network is undergoing a constant transformation, following not only the general pharmaceutical industry trend towards a higher degree of digitalization and automation but also to be ready for Takeda's modality agnostic pipeline. At the same time, the manufacturing network needs to address rising expectations towards the reduction of environmental impact and demographic challenges. Thomas Wozniewski, Global Manufacturing & Supply Officer and member of the Takeda Executive Team, explains how the global TechOps organization is managing this complex transformation.