Attendee login, Virtual Exhibit Hall Open, Meet ups and Networking

Chair’s Welcome Note & Opening Remarks

Natasha Demberg, BSc, MSc, Quality & Compliance, Demberg Pharma Solutions

Bilingual Session:

Virtual Inspections and Remote GMP evaluations (Inspection Trends)

Teresa Forlini, B. Eng. Chemical Engineering, Manager, GMP Inspection – East/West, Regulatory Operations and Enforcement Branch, Health Canada

The CAPA process: The Cornerstone to Build Quality systems

• Key factors of the CAPA procedure and knowledge development
• Understand the inspectional objectives for CAPA and recent industry warning letters
• Discuss the importance of maintaining a strong CAPA program to support product lifecycle
• Understand the CAPA Process and how it impacts the product‘s quality
The presentation will include some practical examples.

Kim Huynh-Ba, Executive Director, Pharmalytik Consulting & Training

Q&A

Virtual Break: Exhibition Viewing and Meet Up (Attendees, Speakers, and Exhibitors)

Session 9: Update on Nitrosamine Impurities Following Publication of FDA Guidance in September 2020

Presented by: Mathieu Fournier, M.Sc., Director, R&D and Scientific Affairs, Neopharm LabsManager, DL Chesney Consulting, LLC,

Session 10: Roundtable Discussions: Chromatographic Data System validation for success (Part 1)

Any question:

• Do and Do NOTs
• Where to Focus
• Project activities and Proportions
• Project team and their share
• more…

Lead by: Kia Kahhali, Founder and CEO, APS Compliance Consultants Inc.

Session 11: Roundtable Discussions: Cost of quality (Part 1)

• What is the real cost of quality ? Or is it non-quality ?
• The answer might surprise you.

Lead by: François Lavallée, M.Sc., President, Aliter Concept

Session 12: Roundtable Discussions: Disaster planning for the GMP labs during the pandemic)

Lead by: Kim Huynh-Ba, Executive Director, Pharmalytik Consulting & Training

To optimize your experience on the roundtable discussions, we encourage participants to submit their questions to in advance to enquiry@ipacanada.com.

Notes: The above breakout sessions we’ve planned based on our initial understanding of the industry needs. We may adjust this line up as the event draws closer. Please check back frequently for updates. More information will be added as it becomes available.

New GMP Trends for Data Integrity

Carlos L Pereira, Regional Manager of Canada, VTI Life Sciences

Q&A

Lunch Break: Exhibition Viewing and Meet Up (Attendees, Speakers, and Exhibitors)

Revised Health Canada Gui-0069: What are the new considerations and what is the impact for the industry?

Tonino Antonetti, M.Sc., Executive Director, Regulatory Affairs & Quality Management, Roche Diagnostics

Q&A

Health Canada, Cleaning Validation Guidelines GUI-0028. Actual version (Jan. 2008) vs new proposal (Nov. 2018) - Comparative discussions

Presentations points:

• Introduction
• Cleaning Validation – Actual vs New approach
• Cleaning validation lifecycle approach
• Analytical methods
• MACO calculations
• Microbiological considerations
• Assessment of cleaning
• General equipment cleaning considerations
• Additional considerations for cleaning of API and cleaning validation of biotechnology processes
• Laws and regulations/International guidance documents
• Questions and discussions

Ovidiu Minailiuc, Ph.D. ing., GMP & Compliance Director, Macco Organiques

Virtual Break: Exhibition Viewing and Meet Up (Attendees, Speakers, and Exhibitors)

Session 13: Roundtable Discussions: Chromatographic Data System validation for success (Part 2)

Any question:

• Do and Do NOTs
• Where to Focus
• Project activities and Proportions
• Project team and their share
• more…

Lead by: Kia Kahhali, Founder and CEO, APS Compliance Consultants Inc.

Session 14: Roundtable Discussions: Cost of quality (Part 2)

• What is the real cost of quality ? Or is it non-quality ?
• The answer might surprise you.

Lead by: François Lavallée M.Sc., President, Aliter Concept

Session 15: Roundtable Discussions:

• Auditing
• Training
• Quality KPi Management
• Risk Assessment
• Data Integrity
• Process Val
• Cleaning Val
• CSV, Quality
• Human Resources Management

Lead by: Adam Hazourli, BSc., Co-founder, Abrevia Incorporated

Session 16: Roundtable Discussions: Process Validation

Process validation sampling and/or setting acceptance criteria

Alan Golden, BS, MS, Principal, Design Quality Consultants, LLC

To optimize your experience on the roundtable discussions, we encourage participants to submit their questions to in advance to enquiry@ipacanada.com.

Notes: The above breakout sessions we’ve planned based on our initial understanding of the industry needs. We may adjust this line up as the event draws closer. Please check back frequently for updates. More information will be added as it becomes available.

How to handle CSV Validation Projects

Adam Hazourli, BSc., Co-founder, Abrevia Incorporated

Q&A

Chair’s Closing Remarks

Natasha Demberg, BSc, MSc, Quality & Compliance, Demberg Pharma Solutions

Conclusion of Conference