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Sunday
08:00am - 12:00pm Eastern - October 30, 2022
Lorrie L. Vuolo-Schuessler, Session Leader, 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; Mrs. 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.


Sunday
09:00am - 12:00pm Eastern - October 30, 2022
Mr. Maurice B. Parlane, B Tech MIT, Session Leader, Principal/Director, New Wayz Consulting Ltd/CBE Pty Ltd; Ms. Tara Scherder, Principal, SynoloStats; Katherine Giacoletti, Principal Scientist, Merck & Co Inc; Dr. Maneesha Altekar, PhD, Technical Director, Product Robustness & Strategy CoE, AstraZeneca

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.


Sunday
01:00pm - 04:00pm Eastern - October 30, 2022
Adam Kiefer, Director, Head of IG Manufacturing, Takeda; Brant Bulgarelli, Session Leader, 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.


Sunday
01:00pm - 04:00pm Eastern - October 30, 2022
Ms. Vivianne J. Arencibia, Session Leader, 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.


Monday
07:30am - 08:30am Eastern - October 31, 2022

With the free ISPE mobile app, you can chat with exhibitors, attendees and speakers. 


Monday
10:00am - 04:00pm Eastern - October 31, 2022

Monday
10:15am - 11:00am Eastern - October 31, 2022

With the free ISPE mobile app, you can chat with exhibitors, attendees and speakers.


Monday

Biologics Facilities: From now and into the future
Carl J. Carlson,
SME - Biopharma Process, Exyte

A Journey to Digitalization: Autolus Therapeutics

Steve Chapman, Partner, Barry-Wehmiller Design Group

Strategies in Updating an Aging Pilot Plant Facility

Jennifer Jacob, Director, MERCK; Shane Helm, Mechanical Design Engineer, Precis Engineering, Inc.; Raymond Ducoat, Director, Process Operations, Merck & Co Inc

New Blender, Old Facility: A Case Study

Lonna Gordon, Senior Process Design Engineer, PM Group

Innovative Modular Facility Design

Peter Hanson, SME, Process Architecture, Exyte

Optimising Commercial Scale Autologous Cell Therapy Facility Design using Discrete Event Simulation

Philip Lyman, Director of Process Simulation, DPS

Plug & Produce: A case study of MODULAR PRODUCTION thanks to MTP (Module Type Package)

Giuseppe Menin, Industry Manager Pharmaceutical, Ing. Punzenberger COPA DATA GmbH

Is high voltage leak detection ready for Annex I and USP?

Andrea Sardella, PhD, Pharma Inspection Product Development, Stevanato Group S.P.A.

Modeling Defects during Tableting: Formation of Bubbles Resulting from Entrapped Air

Joseph Wright, Research Fellow/PhD Candidate, Drexel University


11:00am - 12:30pm Eastern - October 31, 2022
Christine Moore, PhD, Session Leader, Executive Director, Quality Systems & Compliance, Organon LLC; Ms. Vivianne J. Arencibia, Vice President, Global Quality Systems and Compliance, Moderna; Brian Deasy, Senior Vice President, Organon; Wayne Motsek, EVP, Quality, Phlow Corp.

While pharmaceutical GMPs and their associated guidelines recommend a quality unit that is independent of the manufacturing unit, they give little or no information on its organizational construct. This session will explore how to build a pharmaceutical quality system to meet ICH Q10 expectations to “assure the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.”

Additionally, the speakers will address how to build an organization with a sustainable quality culture and meet all necessary compliance requirements internationally. Senior leaders from a start-up company (Phlow), a spin-off company (Organon), and a rapidly growing company (Moderna) will discuss how to balance addressing compliance needs and planning for expanding roles, commensurate with evolving company capabilities and capacity.


Monday
11:00am - 12:30pm Eastern - October 31, 2022
Brian Deasy, Senior Vice President, Organon

In June 2021, Organon spun-off from Merck & Co. (known as MSD outside USA & Canada) to form an independent global healthcare company, with a vision of building a better and healthier every day for every woman. Building a manufacturing quality organization was an essential part of the organizational stand-up. 

In this discussion, the Head of Organon Quality will discuss how the organization has focused on simplifying and right-sizing the organization and processes to be agile, efficient, and to ensure continued flow of products to patients.


Monday
11:00am - 12:30pm Eastern - October 31, 2022
Ms. Vivianne J. Arencibia, Vice President, Global Quality Systems and Compliance, Moderna

In 2020, the company pivoted from a clinical manufacturing company to a world leader in its supply of its mRNA Covid 19 vaccine. The presentation will discuss a company’s journey as it expanded its footprint and built a leading global quality organization to enable delivery of its vaccines worldwide.


Monday
11:00am - 12:30pm Eastern - October 31, 2022
Wayne Motsek, EVP, Quality, Phlow Corp.

Phlow was founded in 2020 to establish reliable domestic supply chains for chronically out of stock essential medicines and to enable supply to underserved markets. COVID elevated the urgency and the company received a contract from the US government (BARDA) to support the mission for targeted APIs and finished doses.

Building a quality focus into the company culture while meeting the needs of an evolving start-up into a credible organization has been an essential part of the company’s growth. After the basic functions are addressed, implementing controlled workflows in advance of changing associated cGMP activities has been the primary driver. 

With no history to reference, the primary challenge is to implement while remaining agile to meet the expectations of multiple US government agencies, contractors, and customers, all in support of the company mission enabling improvements to supply chain reliability for the identified essential medicines and delivery to underserved patients.


11:00am - 12:30pm Eastern - October 31, 2022
Michael Westerman, Session Leader, Vice President, CQV Operations, IPS - Integrated Project Services, LLC; Mr. Chip Bennett, PMP, Associate Director, Global C&Q, CAI; Mr. Paul F. Valerio, Director of Process Technology / Senior Associate, IPS - Integrated Project Services, LLC; Jeffrey Adcock, Global Director, Management & Cost Control, Emergent Solutions

The COVID pandemic, and more specifically, Operation Warp Speed driven projects, rocked the global supply chain and taught the industry that the paradigm of typical project durations could be shattered. The success of a number of these projects has driven the industry to expect an unprecedented level of speed on future projects. Good Engineering Practices are critical to the delivery of compliant biopharmaceutical projects; however, their application is absolutely crucial as design, procurement and verification activities are conducted throughout fast-tracked projects. 

This session will describe the concepts of the guide, the principles and drivers behind its revision, and the practical application of the guide for customers’ use. In addition, speakers will provide a case study of a BARDA funded Operation Warp Speed BSL-2 Aseptic / Isolated Formulation and Filling Facility with a project duration of 11 months from concept to aseptic process simulation readiness, which completely challenged the paradigm and basic understanding of how fast a project would be delivered from concept through CQV.


Monday
11:00am - 12:30pm Eastern - October 31, 2022
Mr. Chip Bennett, PMP, Associate Director, Global C&Q, CAI

This presentation will focus on the main principles and application of the new Good Engineering Practices Good Practice Guide. When the 2nd Edition of Baseline Guide 5, Commissioning and Qualification, was published in 2019, most of the attention about the new Guide was focused on the incorporation of Quality Risk Management (QRM) into the integrated Commissioning and Qualification (C&Q) approach. That attention was merited, as the Guide established the industry-standard approach, strategy, and rationale for science- and risk-based design and delivery of engineered systems. However, equally important, both from a business and regulatory perspective, the Guide established Good Engineering Practice (GEP) as a key enabler for the integrated C&Q process. Just as QRM drives effectiveness of the integrated C&Q process, GEP drives the efficiency of that process. Accordingly, the 2021 publication of the 2nd Edition of the Good Practice Guide: Good Engineering Practice (GEP GPG) updated the definition and understanding of GEP within regulated industry, establishing GEP as a lifecycle system supporting the effective, efficient design and delivery of engineered systems and enabling the QRM-based integrated C&Q process.


Monday
11:00am - 12:30pm Eastern - October 31, 2022
Mr. Paul F. Valerio, Director of Process Technology / Senior Associate, IPS - Integrated Project Services, LLC; Michael Westerman, Vice President, CQV Operations, IPS - Integrated Project Services, LLC; Jeffrey Adcock, Global Director, Management & Cost Control, Emergent Solutions

During this case study, the presenters will take the audience through a complicated, schedule driven project that was chartered by BARDA under the Project Warp Speed program during the height of the Covid-19 pandemic. The primary challenge was to design, build and qualify an integrated Aseptic Isolated Filling Line and ancillary support areas into an existing shell space in an active manufacturing facility in time to deliver critical Covid vaccines to the market place. This forced the entire project team from owner stakeholders to the CQV team to Quality Assurance to work seamlessly and ensure the appropriate controls were in place throughout the process to deliver a functional and compliant line. The team consistently applied the applicable good engineering practices and risk management throughout the process in a streamlined manner to design, build and qualify this facility in record time. 

We will walk the audience through the specification, design, construction management, commissioning and qualification and risk assessments, while focusing on lessons learned and applicability of the GEP guide to the process.