Welcome, ISPE Canada Affiliate

In-person Education and Product Symposium

May 8 – 9, 2023

Plan to join us for the ISPE Canada Education and Product Symposium on May 8 – 9, 2023. The theme of this year’s program is Advancing Canadian Pharma and Biopharma Manufacturing in the “New Normal”.

Advancing Canadian Pharma and Biopharma Manufacturing in the “New Normal"

To ensure product quality and supply chain safety, improving manufacturing efficiency is a key initiative for ISPE while always putting the patient first. Our industry makes products that are life-changing, life-sustaining, and impact hundreds of millions of people worldwide.

The challenges facing the pharmaceutical manufacturing industry have increased with economic and regulatory pressures, technology changes and escalating cost. The way we approach solutions needs to be innovative in order to keep pace with today’s demands.

Monday, May 08, 2023

7:00 - 8:45

Registration Foyer – 11th Floor

7:45 - 8:45

Continental Breakfast & Product Show Montreal B & C – 11th Floor

8:45 - 8:55

Welcome

8:55 10:15

Keynote Session Montreal A – 11th Floor (keynote)

Health Canada’s Lessons Learned from the COVID-19 Pandemic

Session Description
Session Description

Health Canada’s Lessons Learned from the COVID-19 Pandemic

The COVID-19 pandemic created an unprecedented demand on Canada's health care system, which directly affected the pharmaceutical sector. Urgent and immediate action was necessary to minimize disruptions to the global drug supply chain, and access to critical drug products. Over the course of the pandemic, Health Canada aimed to ease the regulatory challenges facing the pharmaceutical industry by introducing various interim measures and regulatory flexibilities. Building from experience, Health Canada is strengthening its emergency preparedness capabilities to facilitate efficient and effective responses to future health crises. The presentation will outline Health Canada’s lessons learned, which are informing how the Department is adapting to the new reality of product innovation and supply chain management, while ensuring appropriate oversight and safeguarding the health and safety of consumers. Key Takeaways:

  • Learn about the regulatory flexibilities that were implemented during the pandemic and how they are shaping the future of regulatory modernization.
  • Identify new policy and regulatory tools for supply chain management.
  • Understand the lessons learned from the pandemic and how they apply to the growing biomanufacturing sector in Canada.
  • Heather Dodson-Manager, Policy and Covid Response, Health Product Inspection and Licensing Health Canada
  • Fiona Frappier-Manager Office Of Pandemic Preparedness and Covid-19, Biologic and Radiopharmaceutical Drugs Health Canada

10:15 - 11:00

Break & Product Show Montreal B & C – 11th Floor

11:00 - 12:00

St. Jacques – 3rd Floor

Applying Lean Six Sigma to Navigating Supply Chain Complexity during the Pandemic Era

Session Description
Session Description

Applying Lean Six Sigma to Navigating Supply Chain Complexity during the Pandemic Era

Lean Six Sigma (LSS) is a powerful methodology which helps reducing process wastes and variabilities if applied successfully. During the Covid19 pandemic, the social restriction has negatively impacted the global Supply Chain around the world and the biopharma industry was one sector among others that have been affected due to delays in material supply chain activities and production. This session will discuss the application of the LSS principles in terms of Supply Chain Re engineering, Collaboration, Agility and Culture. This presentation will also touch on three specific resilience attributes that define Supply Chain’ recovery capability to disruptions.

  • Kossi Molley - Sr. Manager, Manufacturing & Operational Excellence Mivado Global Performance inc

Riopelle – 3rd Floor

The Challenges of Qualifying Ancillary / Raw Materials for Clinical Use in the Cell & Gene Therapy Market

Session Description
Session Description

The Challenges of Qualifying Ancillary / Raw Materials for Clinical Use in the Cell & Gene Therapy Market

As the field of regenerative medicine surges forward with growth in clinical trials and approved therapies, the regulatory landscape of the market continues to evolve. This continued growth has led to increased awareness around the need for specialized and complex materials utilized in their manufacture. Ancillary materials (AMs) are components or reagents used during the manufacture of tissue engineered products but are not intended to be part of the final product(s). Commonly, there are limitations in the availability of clinical-grade reagents used as AMs. Furthermore, AMs may affect the efficacy of the clinical product and subsequent safety of the therapy for the patient. As such, AMs must be appropriately qualified during the product development process. The global regulatory landscape and compliance trends surrounding AMs will be discussed, along with how to identify a good versus poor supplier of Ancillary Materials. Take Away A better understanding of the regulatory landscape for selecting and qualifying ancillary materials and suppliers to optimize a sponsor's cell & gene translational journey.

  • Lynn Csontos - Vice President, Regulatory Affairs STEMCELL Technologies

Victoria – 3rd Floor

ROADMAP TO ECM (ENGINEERING CHANGE MANAGEMENT)

Session Description
Session Description

ROADMAP TO ECM (ENGINEERING CHANGE MANAGEMENT)

The adoption of a Risk-Based Approach to Commissioning and Qualification requires a comprehensive Engineering Change Management (ECM) Program that complements a Quality Change Control Program. An ECM program ensures that all non-critical changes within the GMP space are properly documented, tracked, and managed, thus mitigating risks and ensuring compliance with regulatory requirements. The presence of a well-established ECM program is a critical indicator of an organization's maturity level regarding its ability to transition into a Risk-Based Approach for Commissioning and Qualification of Equipment, Facilities, and related systems. This presentation will provide a practical and detailed roadmap on how to develop and implement an ECM program in the pharmaceutical manufacturing industry. Additionally, it will highlight the differences between a Change Control Record and Change Management Document and introduce a risk-based strategy for developing pre-assessment requirements and categorization for proposed Engineering Changes. This comprehensive approach to ECM is critical for maintaining a state of control and ensuring continuous improvement within the pharmaceutical manufacturing industry.

  • Adnan Abosh, P.Eng. - Associate Director I Equipment & Facility Qualification I GTA Sites, Global Engineering, APOTEX

12:00 - 13:30

Lunch & Product Show Montreal B & C – 11th Floor

13:30 - 14:30

St. Jacques – 3rd Floor

A New Generation of Therapeutics with New Challenges in the New Normal – Latest Developments in Aseptic Filling for Cell and Gene Therapies

Session Description
Session Description

A New Generation of Therapeutics with New Challenges in the New Normal – Latest Developments in Aseptic Filling for Cell and Gene Therapies

CRB will discuss how the latest technological innovations, and collaboration between owners, engineers, and equipment manufacturers has allowed us to meet the process and regulatory challenges associated with filling ATMPs. Cell and gene therapy processes once performed in biosafety cabinets have moved to automated fill lines with Grade A Aseptic isolators. Flexibility with container format for delivery of vials or syringes, streamlined and innovative decontamination processes, and modularized core filling features have changed the way the industry views ATMP filling capabilities. These innovations in equipment design have allowed for optimized process scale, streamlined the shift from clinical to commercial filling, and allowed for significant decreases in facility footprint and design impact. CRB will also be sharing our recent experiences on how equipment complexity and market stressors have driven the need for a holistic approach throughout the design process, from business case to operational readiness. The keys to successful implementation will be discussed, including planning, facility integration of complex process equipment, and a focus on project execution. Learn how CRB had to rethink project timelines, equipment and facility design, and project execution – from initial vendor selection, through design, FAT, and equipment installation. Take Away: - Trends in Cell & Gene Therapy drug product filling technologies - Understanding lifecycle of a typical ATMP filling process under current market stressors

Riopelle – 3rd Floor

PROCESS VALIDATION = QBD + PPQ + CPV

Session Description
Session Description

PROCESS VALIDATION = QBD + PPQ + CPV

THE LIFECYCLE CONCEPT APPLIES TO ALL

  1. QbD, PPQ, CPV
  2. AUDIT TRENDS (US FDA) PRE AND POST COVID
  3. WHAT TO LOOK FOR IN INDUSTRY GUIDELINES
  4. CPV IS NOT APQR. HOW THEY RELATE
  5. A CASE STUDY: APPLICATION OF CPV
  6. ARE YOU SET UP TO UTILIZE Q12 CONCEPTS?
  7. WHAT DOES THE INDUSTRY THINKING
  8. ANSWERS TO COMMON QUESTIONS
  9. REFERENCES Take Away Provides insights into current PV concepts.

Victoria – 3rd Floor

Lessons learned from commissioning a recently renovated facility

Session Description
Session Description

Lessons learned from commissioning a recently renovated facility

Ester and Jamie led and recently completed the commissioning of the utilities and process equipment for the purification area of the first large-scale blood plasma derivative manufacturing site in Canada. The facility was recently acquired by Grifols and underwent significant renovation prior to commissioning. Will include topics such as: -commissioning in an environment of labour shortages and supply chain issues; -challenges in coordinating commissioning resources in different time zones and over video calls; -challenges faced when re-using existing facility equipment; etc.

14:30 15:30

St. Jacques – 3rd Floor

Ensuring Drug Supply Through Digital Supply Chain Enablement and Solutions

Session Description
Session Description

Ensuring Drug Supply Through Digital Supply Chain Enablement and Solutions

Thermo Fisher Scientific is building an integrated digital customer communication platform, which is called mysupply. Customers engage through mysupply for project/program management, forecasting, ordering, set up, manufacturing/packaging and quality, through to distribution and KPI reporting. This provides customers with a more real-time transparent solution to their supply chain needs and enhanced visibility into the development and manufacturing of their medicines, further reducing drug shortages as they serve their patients around the world. This technology investment focuses on building and integrating capabilities into a digital ecosystem with customers and their patients always at the center. Join us to learn more about digital supply chain technology and for a live interactive demonstration which walks through the system and its capabilities.

  • Zaki Khan - Director, IT, Commercial Digital Solutions Thermo Fisher Scientific
  • Noella Dallaire - Sr. Mgr. Portfolio Services Thermo Fisher Scientific

Riopelle – 3rd Floor

Cleaning Validation of a Multi Product Facility – A Risk Based Approach

Session Description
Session Description

Cleaning Validation of a Multi Product Facility – A Risk Based Approach

Cleaning Validation approaches with multi product Biopharmaceutical facility. Risk based approach for Grouping/Bracketing for Cleaning Validation and Cleaning Development. The presentation will discuss different phases of Cleaning validation Program design i.e. Planning (Understand the process, Determine goals, document the approach), Cleaning program development (Process Fundamentals, Process Development) and last Validate and Maintain. Presentation will likely provide real life examples of the approaches considered for Cleaning Process Development and Validation. Presentation will provide a view for selection on multiple CIP and multiple cleaning process grouping consideration, requirements for Cleaning Development on worst case selection. There will be discussion on criteria for worst case grouping and it’s implication. Different risk based approaches for Cleaning Development and Cleaning Validation.

  • Roshan Shah - Senior Validation Manager Hyde Engineering & Consulting

Victoria – 3rd Floor

How to Navigate the Pharma 4.0 wave from a compliance perspective

Session Description
Session Description

How to Navigate the Pharma 4.0 wave from a compliance perspective

Building and maintaining the link between regulatory expectations and business reality is an everyday industry challenge. The Pharma 4.0 change of paradigm is dramatically transforming industry at an unprecedented scale, bringing more opportunity than ever before. During this session, together we will explore the pillars, challenges and benefits of Pharma 4.0, and particularly focus on integration of AI into business processes. From a portfolio of innovative initiatives, I will share lessons learned from completed projects as well as aborted missions. Take Away: Regulatory compliance approach with integration of AI into business processes, with shared lessons learned from completed projects as well as aborted missions.

  • Jovana Nakic - Head of Customer Onboarding and Professional Services GENAIZ/Groupe Uni3T

15:30 - 16:30

Break & Product Show Montreal B & C – 11th Floor

16:30 - 17:30

St. Jacques – 3rd Floor

The Unique Challenges of Cell and Gene Therapies vs Biologics Manufacturing (And Where We Are Not That Different)!

Session Description
Session Description

The Unique Challenges of Cell and Gene Therapies vs Biologics Manufacturing (And Where We Are Not That Different)!

Cell and Gene Therapy manufacturing presents some unique challenges from biologics manufacturing but there are also many similarities. This presentation will go through examples of how the Cell and Gene Therapy field has been able to build from Biologics Manufacturing experience and the strategies we have used to address the unique challenges. Take Away: Understand the similarities and differences between Cell and Gene Therapy Manufacturing and Biologics Manufacturing

  • Gayle Piat - Director, Alberta Cell Therapy Manufacturing (ACTM)

Riopelle – 3rd Floor

Introduction to Pharmaceutical Sustainability: Clean Utility Case Study

Session Description
Session Description

Introduction to Pharmaceutical Sustainability: Clean Utility Case Study

We are proposing an introduction to sustainability in the pharmaceutical based on the ISPE Handbook: Sustainability. This will be followed with a more detailed case study on pharmaceutical water system production methods. The introduction will detail three synergistic workstreams. Concepts to be discussed include minimizing the environmental impact, reducing greenhouse gas emissions, water and waste in these streams. Case study on sustainability will focus on the advantages of different technologies to produce Water for Injection and other critical utilities to support the production of small and large molecule therapies. We will compare different distillation and membrane based generation systems in several global locations to evaluate energy inputs required and optimize the technology choice. We will include an overview of industry accepted sustainability principles along with descriptions of the different technologies. Take Away: This presentation will target Project and Process Engineers that must deliver solutions that support corporate sustainability objectives. Plant operations and reliability engineers will be able to learn about the latest technology developments for clean utility systems.

Victoria – 3rd Floor

Data Integrity & Cloud-Based Systems

Session Description
Session Description

Data Integrity & Cloud-Based Systems

DATA INTEGRITY & CLOUD-BASED SYSTEMS No need to convince the industry on the importance of data integrity in the regular execution of GxP activities. Multiple observations and warning letter have been issued by various regulatory bodies. The subject is a key focus for the pharmaceutical industry at large. For both on-premise and cloud-based systems, the compliance requirements are identical. The specificities of the installation model (on premise, IaaS, SaaS) must be taken into consideration when analyzing data integrity, either in remediation projects or new systems. This presentation will recall the basics of data integrity and then describe the challenges and lessons learned by Laporte on its projects by presenting real case studies. Take Away: What are the main Data Integrity compliance requirements? What responsibilities can be delegated to a cloud-system provider? What additional policies and procedures must be in place when working with a cloud-based system?

17:30 - 19:00

Cocktails & Appetizers Foyer – 11th Floor

19:00 - 21:00

Dinner Montreal B & C – 11th Floor

21:00 - ON

To be announced

Tuesday, May 09, 2023

7:00 - 8:15

Continental Breakfast & Product Show Montreal B & C – 11th Floor

08:15 - 09:15

St. Jacques – 3rd Floor

Trends in ESG Reporting and Digital Transformation

Session Description
Session Description

Trends in ESG Reporting and Digital Transformation

As corporate strategy has drastically shifted in the last 3 to 5 years from Sustainability to Environmental, Social, and Governance (ESG) reporting, many new data management challenges are being posed in the preparation of internal and external enterprise-level reporting. Within the ESG landscape, there is also a growing obligation to shareholders to ensure companies are managing their ESG data to move to a zero carbon future. Join WSP in discussing how companies are approaching the management of larger and more numerous data sets, a growing number of stakeholders involved, and the use historical data for trending & analysis. Take Away * Understanding growing demand and drivers for ESG data collection and reporting * Awareness of how many companies deputize responsibility within multiple corporate-level functions (Environmental, Sustainability, HR, IT, Communications, etc.) * Understanding the challenges posed by a dynamic and expanding landscape for GHG reporting, particularly related to Scope 3 emissions * Understanding how clients approach Digital Transformation through the selection, implementation, and rollout of third-party ESG software platforms

  • Kevin McKee - Vice President, Global ESG Solutions Lead WSP, Digital EHS & ESG Solutions

Victoria – 3rd Floor

Modernizing a legacy facility with Product and Equipment context and AI/ML capability for Reliability and Optimization.

Session Description
Session Description

Modernizing a legacy facility with Product and Equipment context and AI/ML capability for Reliability and Optimization.

Learn how data silos and workflows in a legacy facility were integrated as part of a digital strategy supporting Reliability Centered Maintenance (RCM) to improve equipment performance, maintenance workflows, and optimize maintenance spend. Manual assessments, workflows and investigations were replaced with innovative DataOps solutions to allow users in different teams access to easy analysis and real-time data. Strategic goals include integration with CMMS, ERP, and ad-hoc IIoT to digitize engineering monitoring efforts, and risk assessment and identification of critical failure modes. Take Away Digital strategy for Reliability and Maintenance for aging/legacy facilities Integrating new sensors/equipment with old SCADA systems Identifying difficulties of cross functional implementations (engineering, IT, product) Automating manual performed analysis like Reliability Centered Maintenance

  • Mathew D’souza - Head of Site Asset Management, Engineering Technical Services Sanofi”

09:15 - 10:30

Break & Product Show Montreal B & C – 11th Floor

10:30 - 11:30

St. Jacques – 3rd Floor

Advancing towards sustainability in pharmaceutical manufacturing

Session Description
Session Description

Advancing towards sustainability in pharmaceutical manufacturing

"As the necessity to achieve net-zero global emissions and the importance of using the Earth’s resources in a sustainable manner becomes ever more apparent, how can manufacturers of high-quality pharmaceutical products advance towards reducing or eliminating their impact on our natural environment? In this presentation, we will discuss what sustainability means in an industrial context, how to quantify and evaluate environmental impacts through life cycle analyses, and what specific measures manufacturers may take to reduce their burden on the most pressing environmental issues. Take Away: Attendees can expect to take away a new way of approaching decisions which impact the environment, and an enhanced view on what sustainability means for their organizations and for their personal lives.

Victoria – 3rd Floor

Best Practices for major retrofit implementation in Biotech site with ongoing commercial cGMP activities.

Session Description
Session Description

Best Practices for major retrofit implementation in Biotech site with ongoing commercial cGMP activities.

Construction activities are typically risky to cGMP activities nearby due to contamination and other impacts. This presentation will show case how Resilience managed and minimized the risk by implementing methodology and meticulous processes to ensure cGMP quality risks and construction schedule risks are both minimized to achieve company goals.

  • Aqeel Monpuri - Senior Manager Capital Project and Portfolio Resilience Biotechnology Inc

11:30 - 12:30

Montreal C – 11th Floor (keynote)

Healthy Work Culture in a Hybrid World

Session Description
Session Description

Healthy Work Culture in a Hybrid World

An opportunity to discuss and share experiences and ideas in creating and maintaining a healthy corporate culture in a hybrid world.The panelist represent organizations that are authentically engaged with programs to enhance a healthy corporate culture.

12:30 - 12:45

Closing Ceremony Montreal B & C – 11th Floor

13:00 - 16:00

Board Meeting with Lunch included Montreal B & C or one of the breakout rooms

Attendee Registration

Attendee passes include access to exhibits, educational sessions and all meals including Monday evening dinner

Registration Category Fee
Members $675.00
Non-members $800.00
Group (5+) at $650 each (membership not required) $3,250.00
Young Professionals (ISPE Membership Required) $350.00
Students (ISPE Membership Required) $50

Register now to attend this event

Attendee Registration Monday Evening Reception and Dinner

Exhibitors Opportunities

Exhibition Level Fee
10 × 10 Booth Exhibitor ( two attendees ) $3,500
TableTop Exhibitor ( one attendee ) $2,000

Additional charges will apply for passport program and power-drop

Program Fee
Passport Program (unique opportunity to interact with attendees) $300
Power-drop (standard power cord included with exhibit package) Contact Dina Iezzi at info@ispecanada.org

Symposium Exhibitor Registration Is Now Open

Tabletop Exhibitor Registration Booth (10×10) Exhibitor Registration Passport Program Registration

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PRODUCT SYMPOSIUM – Sponsors

ISPE Canada Affiliate sincerely thanks the ongoing support of our sponsors and exhibitors. This support helps to make our events possible at a reasonable cost to the attendees.

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Registration for this event is now open.

Attendee Registration - Education and Product Symposium 2023
Out of stock

ISPE Canada Education and Product Symposium - May 8 - 9, 2023

Attendee Registration – Education and Product Symposium 2023

$800.00
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Monday Evening Reception and Dinner starting at 5:30
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ISPE Canada Education and Product Symposium - May 8 - 9, 2023

Monday Evening Reception and Dinner starting at 5:30

$150.00
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Tabletop Exhibitor Registration
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ISPE Canada Education and Product Symposium - May 8 - 9, 2023

Tabletop Exhibitor Registration

$2,000.00
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Passport Program Registration
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ISPE Canada Education and Product Symposium - May 8 - 9, 2023

Passport Program Registration

$300.00
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Booth (10×10) Exhibitor Registration
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ISPE Canada Education and Product Symposium - May 8 - 9, 2023

Booth (10×10) Exhibitor Registration

$3,500.00
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Platinum Sponsor Registration
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ISPE Canada Education and Product Symposium - May 8 - 9, 2023

Platinum Sponsor Registration

$3,000.00
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Platinum Sponsor Registration
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Platinum Sponsor Registration

$3,000.00
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Gold Sponsor Registration
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ISPE Canada Education and Product Symposium - May 8 - 9, 2023

Gold Sponsor Registration

$2,000.00
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Silver Sponsor Registration
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ISPE Canada Education and Product Symposium - May 8 - 9, 2023

Silver Sponsor Registration

$1,500.00
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Bronze Sponsor Registration
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ISPE Canada Education and Product Symposium - May 8 - 9, 2023

Bronze Sponsor Registration

$1,000.00
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Emerging Leader Sponsor Registration
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ISPE Canada Education and Product Symposium - May 8 - 9, 2023

Emerging Leader Sponsor Registration

$500.00
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