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: Update on Health Canada GMP Guidance Documents / Mise à jour sur les Lignes Directrices de Santé Canada

Magda Joseph, B. Eng., Regional Supervisor, GMP Inspection - East, Regulatory Operations and Enforcement Branch, Health Canada/Government of Canada

2020 Draft of Annex 1 of the EU Guide to Good Manufacturing Practices for Sterile Medicinal Products

• An overview of key new requirements
• Learn how to develop a compliant Contamination Control Strategy (CCS)
• Review new and expanded sections on utilities and innovative technologies for aseptic processing

Q&A

Michael Hodgkinson, B.S., Owner and Principal Consultant, Orvera Scientific Ltd

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

Session 1: 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 2: Roundtable Discussions: Coût de la qualité (Part 1)

• Quel est le coût de la qualité ? Ou est-ce la non-qualité ?
• La réponse pourrait vous surprendre.

Lead François Lavallée, M.Sc., Biologiste organisationnel et président de Aliter Concept.

Session 3: Roundtable Discussions: Quality Risk Management

Lead by: Michael Hodgkinson, B.S., Owner and Principal Consultant, Orvera Scientific Ltd.

Vamsi Kosaraju, M.Sc., Director, Quality Assurance, Teva Canada Limited

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.

Contamination Control

David W. Vincent, PhD, CEO, VTI Life Sciences

Q&A

Virtual Break: Exhibition Viewing

FDA GMP Update and Compliance 2020

David L. Chesney, MSJ, DL Chesney Consulting, LLC. Former FDA

Q&A

Analytical Laboratory Quality Practices from R&D to GMP

Nadine M. Ritter, Ph.D., President and Senior Analytical Advisor, Global Biotech Experts, LLC

Q&A

What Does it Mean to Meet Your Labeled Specifications?

• Compendial guidelines on meeting label claims
• Stability requirements to meet your label claim
• Overage and the impact
• Statistical methods to product OOS based on release data

Steven Walfish, President, Statistical Outsourcing Services

Q&A

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

Session 4: 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 5: Roundtable Discussions: Coût de la qualité (Part 2)

• Quel est le coût de la qualité ? Ou est-ce la non-qualité ?
• La réponse pourrait vous surprendre.

Lead François Lavallée, M.Sc., Biologiste organisationnel et président de Aliter Concept.

Session 6: Roundtable Discussions: Analytical Methods

Lead by: Nadine M. Ritter, Ph.D., President and Senior Analytical Advisor, Global Biotech Experts, LLC

Steven Walfish President, Statistical Outsourcing Services

Session 7: Quality Systems Management

Presented by: David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC,

Session 8: 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 Labs

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.

Identify Key Learnings and Common Roadblocks to Ensure Successful Audits

This Session will be highly interactive with audience members actively participating in an open discussion of their audit experience. Through discussion and examples, participants will gain an understanding of how to prepare for and audit, strategies to conduct a successful audit, ways to respond to audit observations and remote audits. The following topics will help guide the discussion:

Preparing for a third-party audit or inspection

• Assembly of an audit team
• Prestaging of documents and records
• Preparing “back room”

Conducting the audit

• Required staff
• Opening meeting
• Tours
• Notes and communication

Responding to audit findings

• Response team
• How fast
• Next steps

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

Q&A

Chair’s Closing Remarks

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

Conclusion of Day 1 Conference