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04:00pm - 05:30pm EDT - November 2, 2021
William G. Whitford, Leader/Speaker, Life Science Strategic Solutions Leader, DPS Group; Namya Syal, Session Leader, Process Engineer, CRB; Kristina Pumphrey, PE, Director of Process Engineering, Precis Engineering + Architecture; Timothy W. Lisle, Sr. Director of Process Architecture, Precis Engineering, Inc.; Andrew JN Baird, PE, Solutions Director, Jacobs; Trevor Stenzel, Operations Manager - Advanced Manufacturing Services (AMS), Jacobs
Track: Facilities and Equipment

Concurrent Session: Steps to Success in a Pharma Facility|There are emerging requirements for the safe and effective manufacturing of such new entity types as ATMPs and 3D cellular constructs. Factory-in-a box advances including prefabricated design, and process simplifications are providing flexible and future-proofed facilities. 4.0 developments in pharma now include digital twin modeling, vision guided robotics and packaging automation. This session will explore evolving approaches to facility design and scale-up planning, as well as automation in process trains that support such emerging entities as cell therapies and printed organoids.
Tuesday
04:05pm - 04:25pm EDT - November 2, 2021
Kristina Pumphrey, PE, Director of Process Engineering, Precis Engineering + Architecture; Timothy W. Lisle, Sr. Director of Process Architecture, Precis Engineering, Inc.
Over the past decade the landscape of the pharmaceutical industry has changed with the innovations of new technologies, like ATMPs. There are more start-up companies that are looking for their first manufacturing space. This presentation will look at the challenges a companies faces at the start of their manufacturing journey. Understanding initial needs and how to get through the early stages of growth is the first key to long-term company success. This presentation will address newly evolving scale-up and manufacturing needs related to ATMP processes, associated equipment, and facilities supporting these operations. We will look at challenges and lessons learned in designing the first manufacturing facilities often on a limited budget. With proper planning and assistance the client can navigate the regulatory and quality requirements within specific budget and schedule constraints.
Tuesday
04:25pm - 04:45pm EDT - November 2, 2021
Andrew JN Baird, PE, Solutions Director, Jacobs; Trevor Stenzel, Operations Manager - Advanced Manufacturing Services (AMS), Jacobs
This presentation describes the potential benefits provided by the further use of robotics and automation in the pharmaceuticals industry. Through a plethora of legacy and emerging robotic technologies, there are endless areas for automation to exist within a pharma facility. This presentation describes a few of those cases as well as the process in which we go about implementing these automated solutions. Topics include, but are not limited to: 3D Simulation, Digital Twin, Robots versus Cobots, Adaptive Gripper Technology, Vision-Guided Robots, AGVs, and the current state of Robots and the Pharma industry. This presentation includes multiple case studies. Specifically, a case study involving a Festo Pharmaceutical Additives Packaging Line that has been completely automated. Presenters will also begin to dig in to the process that we are currently going through in order to fully-automate a Pharma facility that handles Plasma Bottles.
Tuesday
04:45pm - 05:30pm EDT - November 2, 2021
William G. Whitford, Life Science Strategic Solutions Leader, DPS Group
Both 3D bioprinting technologies and applications are developing at an extremely fast pace. Diverse analytical and diagnostic products made using bioprinting technologies include microfluidic devices, organ-on-a-chip systems, and 3D in vitro tissue models for both drug research and clinical diagnostics. Therapeutic products are also beginning to be developed and include bioprinted patches, tissues, and even organs. For the regulation of these products, the US FDA has spoken on the issue of the certification of 3D printed medical devices. However, 3D bioprinting technology is so new and dynamic that basic questions remain regarding practical requirements for the manufacturing of diagnostic and therapeutic materials, devices and cell therapies. Facility and work-flow solutions are dependent upon many process design and compliance factors. As technological and regulatory obstacles are being removed, the development of biomanufacturing operations raises new considerations. These considerations include whether the product is indication-specific, patient-specific or customizable- as well as hospital-made or mass produced. We will present current thoughts on facilities and workflows for the regulated manufacturing of 3D bioprinted products.
04:00pm - 05:30pm EDT - November 2, 2021
Aaron Weinstein, Session Leader, Senior Director, Compliance Consulting, IPS – Integrated Project Services, LLC; Padraig Culbert, Chief Executive Officer, Connect Academy; Philip M. Gammell, Associate Director of Engineering, Astellas Pharma Inc.; Elizabeth Rivera, Technical Services Manager, STERIS Corp; Dori Gonzalez-Acevedo, MA, Vice President of Strategic Solutions, Tx3 Services
Track: Supply Chain, Operations, and Packaging Excellence (SCOPE)

Concurrent Session: Improving Operations Through Efficiency|Digital work instructions are a tool that is becoming more and more prevalent. Digital work instructions can help personnel be more efficient while capturing critical data can allow manufacturing, QC, and warehouse managers to more quickly improve the way task steps are executed.   In this session, Improving Operations Through Efficiency, presenters from the manufacturing and software sides will discuss the IT challenges and the impact to business and regulatory to consider when implementing this exciting technology.  As quality and Digital Transformation become more important, Testing and SQA teams must adapt, changing compliance and documentation practices to adopt modern tools and methodologies. Many organizations struggle with how to make this transformation possible.  Utilizing a case study, one part of this session will discuss how to modernize software compliance to support digital transformation and the strategic adoption of a CSA model to improve efficiency while remaining compliant with regulatory bodies and your own Quality Organization. Additionally, GMP industry has been scrutinizing vendors/suppliers with more rigorous qualification programs to determine if they can provide the necessary goods or services to the standards that the GMP company requires. The Quality System approach calls for periodic auditing of suppliers based on risk assessment either by paper, on-site, or both even for processing aids such as cleaners, disinfectants and other Life Sciences consumables.  As part of this session, risk-based evaluations of process aids and how these may impact the process, assigning requirements based on risk level and industry trends for compliance for vendors of processing aids, will be discussed.
Tuesday
04:05pm - 04:25pm EDT - November 2, 2021
Philip M. Gammell, Associate Director of Engineering, Astellas Pharma Inc.; Padraig Culbert, Chief Executive Officer, Connect Academy

Many companies are exploring digitalisation and the key challenges they face, include trying to predict how these new technologies and methods will integrate into their businesses and deliver important benefits. Regulatory compliance is also a key consideration. This presentation will cover an important case study into these issues. Astellas implemented digital work instructions in the GxP operation of a pharmaceutical packaging line as part of a pilot aimed at examining the value of the new technology and methods for the business. The digital work instruction solution was implemented by Connect Academy. The study examines the results of the pilot to date across four strands: human factors, technology, regulatory and business.
Tuesday
04:25pm - 04:45pm EDT - November 2, 2021
Elizabeth Rivera, Technical Services Manager, STERIS Corp
Since the launch of FDA Guidance on Quality Systems (QS), the GMP industry has been scrutinizing vendors/suppliers with more rigorous qualification programs to determine if they can provide the necessary goods or services to the standards that the GMP company requires. The QS approach calls for periodic auditing of suppliers based on risk assessment either by paper, on-site, or both even for processing aids. The supplier approval process may include proof or completion of some (or all) of the following: Certified quality system such as ISO, supplier/quality questionnaire, product specifications, change notification policy, contingency planning policy, among others. This presentation will help understand a vendor/supplier’s position on QS compliance to meet GMP needs. Examples will be provided using processing aids such as cleaners, disinfectants and other Life Sciences consumables.
Tuesday
04:45pm - 05:05pm EDT - November 2, 2021
Dori Gonzalez-Acevedo, MA, Vice President of Strategic Solutions, Tx3 Services
Burdensome documents have become the focus of Computer Systems Validation and the testing of regulated systems. As actual quality and Digital Transformation become more important, Testing and SQA teams must adapt, changing compliance and documentation practices to adopt modern tools and methodologies. Many organizations struggle with how to make this transformation possible. Through a case study analysis, Tx3 will discuss how to practically modernize software compliance to support digital transformation and the strategic adoption of a CSA model. This presentation will cover: Enable Digital Validation – more than just applying electronic signatures; Support Digital Transformation while complying to regulations; How to apply the CSA model to a modern CSV program; and Best practices – considering your people, processes, and technology.
04:00pm - 05:30pm EDT - November 2, 2021
Betsy P. Fritschel, Session Leader, Director, Regulatory Compliance, Johnson & Johnson; Nina S. Cauchon, PhD, Director Regulatory Affairs - CMC, Amgen Inc.; Stephen Mahoney, Executive Director, Global Quality & Compliance, Genentech, A Member of the Roche Group; Andrew Chang, PhD, Vice President, Quality and Regulatory Compliance, Novo Nordisk Inc.
Track: Quality Systems and Regulatory

Concurrent Session: What's New from ICH?|This session features industry members from active ICH working groups providing insights on four important documents.  Three of these documents will be available for Step 2 Public Comment in the fall of 2021.  Don’t miss the opportunity to get insights from the industry experts who developed the text in the documents as you prepare to review and provide comments on ICH Q2(R2) Analytical Method Validation, ICH Q14 Analytical Method Development, and ICH Q9(R1) Quality Risk Management.  You will also hear about implementation progress on ICH Q12 Lifecycle Management including tools and enablers.
Tuesday
04:05pm - 04:25pm EDT - November 2, 2021
Nina S. Cauchon, PhD, Director Regulatory Affairs - CMC, Amgen Inc.
A new Quality guideline, ICH Q14 (Analytical Procedure Development) is being proposed in order to facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures, improve regulatory communication between industry and regulators. ICH Q2(R1) Guideline on Validation of Analytical Procedures is also being revised. Together, these two guidelines will provide harmonized and streamlined concepts for a diverse variety of analytical procedures, including examples. The use of an enhanced approach for analytical procedure development using concepts such as the Analytical Target Profile (ATP) and the application of prior knowledge and risk management principles will be described. Regulatory recommendations for reporting analytical procedure development activities in submissions will be discussed, along with opportunities to present a scientific basis for flexible regulatory approaches to post-approval Analytical Procedure changes.
Tuesday
04:25pm - 04:45pm EDT - November 2, 2021
Stephen Mahoney, Executive Director, Global Quality & Compliance, Genentech, A Member of the Roche Group
Members of the ICH Expert Working Group (EWG) will provide an overview of the ongoing work to update the current ICH Q9 Guideline on Quality Risk Management (QRM). In particular, the Q9(R1) EWG will discuss the following harmonization activities: (1) making limited and specific adjustments to chapters and annexes of current ICH Q9 Guideline; and (2) developing specific training materials (with examples) to supplement the existing ICH briefing pack on ICH Q9, as well as to explain and facilitate the implementation and application of the proposed revisions.
Tuesday
04:45pm - 05:05pm EDT - November 2, 2021
Andrew Chang, PhD, Vice President, Quality and Regulatory Compliance, Novo Nordisk Inc.
ICH Q12 is a transformational guideline that was endorsed in November 2019 at the ICH biannual meeting in Singapore. It has a wide scope of applicability and builds on the framework laid down in ICH Q8, Q9, Q10 and Q11 guidelines and aims to address key remaining technical and regulatory hurdles that prevented the full adoption and implementation of flexible science- and risk-based approaches to post-approval chemistry, manufacturing and controls (CMC) change management during commercial manufacturing. Currently, both the industry and regulators are actively working to develop ICH Q12 adoption and implementation plans. This presentation will include insight of ICH Q12 IWG workplan and activities, current implementation status within specific countries, e.g., USA, Japan, Canada, and China, and personal remarks on opportunity and challenges of global implementation of ICH Q12 to enhance efficient and effective product lifecycle management.
09:00am - 11:00am EDT - November 3, 2021
Betsy P. Fritschel, Session Leader, Director, Regulatory Compliance, Johnson & Johnson; Sarah C. Pope Miksinski, PhD, Moderator, Executive Director, CMC Regulatory Affairs, Gilead Sciences, Inc.; Roberto Conocchia, GMP Technical Lead, European Medicines Agency (EMA); Tara R. Gooen Bizjak, CDR, Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality, OPQ/CDER, FDA; Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization; Ian Jackson, Unit Manager, Inspection Risk, Control and Governance, MHRA; Dr. Jennifer Maguire, PhD, Director of the Office of Quality Surveillance, CDER/FDA; Ewan Norton, Lead Senior GMDP Inspector, MHRA; Mahesh R. Ramanadham, Pharm.D./M.B.A., Deputy Director, FDA/CDER/OPQ/OPPQ; Ian Rees, Unit Manager Inspectorate Strategy & Innovation, MHRA; Raphael Sanches Pereira, Health Regulation and Surveillance Specialist, Anvisa; Lawrence X. Yu, PhD, Director, Office of New Drug Products, OPQ/CDER/FDA

Wednesday
09:00am - 10:50am EDT - November 3, 2021
Sarah C. Pope Miksinski, PhD, Moderator, Executive Director, CMC Regulatory Affairs, Gilead Sciences, Inc.

Town Hall: Global Regulatory Insights on Current Issues – Harmonization and Convergence|

This highly engaging session and panel discussion features regulatory experts from ANVISA, EMA, MHRA, USFDA, and WHO answering your questions on:

  • Inspections/Remote Evaluations during COVID and Learnings
  • The Future of Submissions (eg. Cloud-based) and Lifecycle Management
  • Global Compliance Issues
  • Quality Maturity, Quality Risk Management, and Supply Chain Resilience


Download the ISPE App to submit your questions anytime during the conference for this international panel of regulatory experts.  Enter new questions and vote on those of highest interest.
Wednesday
10:50am - 11:00am EDT - November 3, 2021
Thomas B. Hartman, President and CEO, ISPE

Closing Remarks and Adjourn|