Presenters:
Dalia Haddad, Senior International Advisor, Health Product Inspection and Licensing Division, Health Canada
Jessica Paterson, Corporate Compliance and Enforcement Advisor, Health Product Inspection and Licensing Division, Health Canada

Panel Q&A:
Dalia Haddad, Senior International Advisor, Health Product Inspection and Licensing Division, Health Canada
Jessica Paterson, Corporate Compliance and Enforcement Advisor, Health Product Inspection and Licensing Division, Health Canada
Camille Bienvenue, Regulatory Affairs Advisor, Licensing management section of the Drug Establishment Licensing Unit (DELU), Health Canada

Presenter: David L. Chesney, MSJ, Principal And General Manager, DL Chesney Consulting, LLC Former FDA

Presenter: Steven Walfish
President, Statistical Outsourcing Services

Presenter: Neola Henry, Senior Corporate Compliance and Enforcement Advisor in the Health Product Inspection and Licensing Division, Health Canada

1. Present the decision of Genus vs. FDA.
2. Present the FDA’s stance on reclassifying drugs as devices.
3. Present an overview of what products are being affected by the new interpretation of the regulations.
4. Present the quality impact to drug manufacturers who now have to be compliant to device regulations
5. Present what options companies have to ensure their quality systems are compliant to 21 CFR Part 4: Regulations of Combination Products.
6. Present anticipated regulatory actions to be taken in the coming years to address these new regulations

Presenter: Mr. Stephen Tyrpak, Executive Consultant, PQE Group (Pharmaceutical Quality Europe) and also leads the Medical Device Operations for the US and Canada.

We are going to discuss common challenges between Quality and Business, why those challenges are present, what are the indications of an ineffective relationship and what are the contributing factors. The ways to create efficient working relationships and the possible action plan, as well as the continuous improvement actions will be discussed.

Presenter: Natasha Demberg, President, Demberg PharmaSolutions

Abstract: Sydney Dekker, author of The Field Guide of Understanding Human Error, states that humans are the only touchpoint between the product and all other organizational factors. When errors, deviations, or accidents occur, firms often tend to focus their investigational efforts at the touchpoint, the people. However, there are many factors that influence performance, including company culture and leadership. This presentation provides a brief overview of Human Error Prevention concepts, and a few basic strategies leaders can adopt to create a safe, blame-free culture that can help prevent errors, and improve performance and compliance along the way.

1. Human Error Prevention overview
2. Organizational factors that influence performance
3. Strategies for prevention
4. Conclusion and final thoughts

Presenter: Matt Peplowski, Founder, BioPharm Error Prevention Associates, Inc.

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

Latest update of Health Canada guidance for nitrosamine impurities. How to successfully manage complex nitrosamines (case studies)

Presenter: Mathieu Fournier, Chief Scientific Officer (CSO), Neopharm Labs

Given the recent restrictions during the COVID19 pandemic, validation specialists and other pharmaceutical experts could not always travel to the manufacturing sites to execute the required qualification tests.  Those tests had therefore to be prepared and performed long distance through a combination of local expertise and remote support from experts.

This presentation will explain the advantages and disadvantages of such an approach and will explain how to prepare for and how to manage long distance qualification execution of complex systems.

Qualification and validation consideration when acquiring used equipment

Because of the very high investment required to purchase pharmaceutical manufacturing equipment and systems, acquiring second hand equipment in good condition may be a good opportunity. However, the state of the equipment is not the only aspect to be considered when taking that decision. Often forgotten are software specifications, compatibility with other systems, availability of spare parts or third-party service; all of which need to be research beforehand.

This presentation aims to list and explain several of the points to be considered to help make the best decision.

Presenter: Masha Ivankovic, eng.

• Optimized manufacturing and change control
• Using the Risk-Based Approach in Defining User Requirements
• The importance of clear roles and responsibilities 
• Proper determination of Maximum Safe Carryover (MSC)
• Health-based exposure limits (HBELs),
• The trends and data analysis that support a total contamination control strategy (CCS).
• How to correlate or centralize trending of disinfectant qualification
• Effectiveness of cleaning, 
• Risks in Environmental Monitoring and Utility Monitoring
• Personnel gowning, and qualification. 
• Trending for investigational purposes across all contamination control elements to assist with root cause determination
• Doing Digital or Being Digital

Presenter: Parsa Famili, MSc, President & CEO, Novatek International

TBC

I. What is Sampling

• Sampling is the ability to make a quality determination on a large number of things without direct examination of each thing

II. Validation Sampling

• Not the same as lot acceptance sampling
• Differences

III. Setting up a Validation Sampling Plan

• Five step method

IV. Using sampling plans to set acceptance criteria for process validation
V. Concept of risk based decisions
VI. The concept of Acceptance Criteria in Test Method Validation

• Variance, how much is too much
• How to measure variance and why

VII. Use of Process Capability

• The concept of process capability
• Cp vs CpK
• How to use process capability to set acceptance criteria for test method validation

VIII. Statistical Process Controls

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

1. Present Regulatory Trends and 483/Warning Letter Landscape
2. Present Global Trends in CSV (Computer Systems Validation)
3. Present Global Trends in DI (Data Integrity)
4. Present Cyber Security Global Trends (Risk Analysis, Vulnerability and Penetration, Maturity Assessment, etc.)
5. Present Gap Assessment, Audit and Remediation pre-Covid
6. Present the Evolution of Gap Assessment, Audit and Remediation during the Covid-19 Pandemic (with Case Study)
7. Present Vbox Technology
8. Present the utilization of Smart Glasses (Augmented Reality) Technology
9. Question and Answers

Presenter: Mr. Gaurav Walia, M.S., Senior Global Director of Business Development and Principle SME of Computer Systems Validation and Data Integrity at PQE Group (Pharmaceutical Quality Europe).

Presenter: Kia Kahhali
Consultant at APS Compliance Consultants Inc.
Access Pharma Solutions

The last 2 years were extremely challenging for all industries, and for us in the life science we had to face new challenges, some of them common to all sectors and some others were more specific to us, let’s take the time to reflect on we can do better, by finding together some strategies to better address those major crises.

Presenter: Adam Hazourli BSc, Regulatory and GMP Compliance, Consultant
President and Founder of Abrévia inc