ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Advancing Canadian Pharma and Biopharma Manufacturing in the “New Normal.”

Biopharmaceutical and Pharmaceutical industries are undergoing dramatic changes that will affect the design and operation of facilities. A rapidly changing market environment has also affected CMO and CDMO operations, where customer demands increasingly require the manufacture of drugs in smaller volumes. Therefore, a multidisciplinary approach is essential for designing an end-to-end program that addresses all operations, from selecting raw materials to distributing final products.

The ISPE Canada Board (list of members can be found Canada Affiliate Board – ISPE Canada Affiliate) would like input from our community about topics that would be of interest to the biologic and pharma manufacturing industry that supports the 2023 Annual Education and Product Symposium Theme. If a particular subject, person, or presentation would be of general interest, we welcome your suggestions and value this input.

We are seeking speakers that have expertise in the below potential categories

• Pharma 4.0
  • Digitalization and Big Data challenge and Management
  • Automation and continuous process verification
  • “Plug & Produce” vertical and horizontal equipment integration
  • Highly automated processes using the Internet of Things (IoT)
  • Robotics & Artificial Intelligence (AI)
  • Cloud-based validated data systems
• Validation & Quality
  • Canadian Pharma and Biopharma Regulatory Challenges
  • Lab Equipment and Method Qualification
  • Deploying Quality Culture Case Studies
  • Successful Implementation of a 3 Stage Process Validation Program Case Studies
  • Continued Process Verification (CPV)
• Facilities & Operations
  • Adopting emerging technologies to improve drug quality Facility Design & Expansion: Case Studies
  • Migrating aging facilities with innovative solutions and technology
  • Pharma Facility of the future
  • Holistic approach to Biopharma Process Transfer
  • Consideration of Risk Assessment in Pharma and Biotech Manufacturing Operation: Case Studies
  • QBD for Product and Process Control Strategies: Case Studies
• New Modalities
  • Building Cell & Gene Therapy Facility
  • Cell & Gene Therapy Facility Operation and Management
  • New Trends and Challenges in Canada’s Pharmaceutical markets
  • Effective Phase-Appropriate Quality and cGMP Program for DS and DP development: Case Studies
• Sustainability
  • Single Use vs Re-usable Case Studies
  • Net zero Energy Use
  • Strategies for Waste Reduction
  • Use of Novel Environmental Cognizant Technologies
• Supply Chain & Drug Shortage
  • Clinical Supply Chains Best Practices
  • Supply Chain Operational Excellence
  • Cold Chain Management: Good Practices
  • Biologic Drug Supply Chain Management
  • Blockchain and Serialization Risk Assessment in Supply Chain

QC Speakers’ time slots are 50 minutes, including time allocated for audience questions. Presentations will be formatted on ISPE Template, which will be provided, and should not be advertorial.
Preference will be given to discussions that:

• Are relevant to our audience in the six (6) categories mentioned above
• Include “Lessons Learned” from completed projects
• Discuss “New or Emerging Trends”
• Include “Innovation”
• Takeaway Tools

Submission Process

Information to be submitted:

1. A brief synopsis of the presentation and how it relates to the above six (6) categories
2. The target audience that will benefit from the presentation
3. Speaker biography and photo
4. Any restrictions in your timing on the two (2) days of the Symposium

 

Fill out the Speaker form