TIME

OUTLINE

7:30 AM – 8:30 AM

Registration, Networking and Continental Breakfast

8:30 AM – 8:45 AM

Chair’s Welcome Note & Opening Remarks
Natasha Demberg, President, Demberg PharmaSolutions

8:45 AM – 9:15 AM

I work in preclinical research – do I need GLP/GMP?

Elizabeth B. Vadas, PhD, FAAPS, FCSPS, InSciTech Inc.

This question arises often in small drug discovery groups, academic labs, virtual and small companies with no internal drug development expertise. The question coming from the discovery scientists, medicinal chemistry or biology is understandable; the role is to create new chemical entities and demonstrate their biological activity in in vitro studies or in vivo in animals.

However, as soon as a molecule is declared a lead candidate with the eye toward clinical development GLP and GMP come to play a role. This can involve qualification of contract organizations that become service providers to and an extension of the small company; the API manufacturer, the toxicology lab, the formulation development contract organization, just to name a few.

In a regulated environment, such as the pharmaceutical industry, there is no substitute for “playing by the rules”.

9:15 AM – 10:00 AM

Update, Guidance on nitrosamine impurities in medications

Eric Desautels, Acting Regional Supervisor, GMP Inspection-East. The Health Product Inspection and Licensing Division, Health Canada

10:00 AM – 10:45 AM

Trends in the industry for impurities management

Mathieu D. Fournier, Chief Scientific Officer (CSO), Neopharm

As a leader in the analytical service support, Neopharm is involved in a constant overview of the trends ongoing in the pharmaceutical industry.  For this presentation, we thought it would be beneficial to share the most recurring challenges & opportunities we observed during the last months.  We want to ensure the pharma companies are aware of all these topics, but we also hope this presentation will help to identify the best approaches to address them.

• Extractables & Leachables for Medical Devices (ISO 10993-18) and Production Plastic Components (USP <665>)
• Considerations for Filter Validation
• Approaches for Nitrosamine Mitigation
• Azides Impurities
• PFAS Impurities
• ICH Q14 upcoming guidance for QbD Method development

10:45 AM – 11:00 AM

Mid-morning Refreshment Break & Exhibition viewing

11:00 AM – 11:45 AM

Applications of GMP to Pharmaceutical Stability Studies

Geoff Carr, PhD, Pharmaceutical Consultant

Abstract

Stability studies are a very important part of any pharmaceutical development program and require a major commitment for both Scientist and equipment resourcing. In order to ensure reliability of data and scientific integrity, it is vital that high levels of GMP are applied to all aspects of these studies. Even at early stages of development, this is recommended as important formulation and manufacturing decisions are likely to be decided from the results obtained.

This presentation will provide some practical examples of how to apply GMP to:

• Qualifications and maintenance of stability chambers
• Management of samples in chambers
• Testing of stability samples 

11:45 AM – 12:15 PM

Morning Panel Q&A and Discussions

Elizabeth B. Vadas, PhD, FAAPS, FCSPS, InSciTech Inc.

Eric Desautels, Acting Regional Supervisor, GMP Inspection-East. The Health Product Inspection and Licensing Division, Health Canada

Mathieu Sim, Acting Regional Supervisor, GMP Inspection-East. The Health Product Inspection and Licensing Division, Health Canada
Mathieu D. Fournier, Chief Scientific Officer (CSO), Neopharm

Geoff Carr, PhD, Pharmaceutical Consultant

12:15 PM – 1:15 PM

Networking Lunch & Exhibition Viewing

1:15 PM – 2:00 PM

Cleaning Validation Program Regulatory and Industry Standards Expectations (EMA, FDA, HC PICs, ISPE, PDA, ASTM, – include Annex 1)

David W. Vincent, B.Sc., MPH, PhD, Chief Executive Officer (CEO), VTI Life Science

Agenda Overview

This session presents the Global Cleaning Validation regulatory and most current global industry guidelines as well.

• EU GMP Annex 1 and 15
• FDA 21 CFR Cleaning Regulations
• EMA “Shared Facilities Guideline” (incl. PDE concept)
• PIC/S PI 006
• APIC Cleaning Validation Guidance for APIs
• Heath Canada – Cleaning Validation
• FDA Guide to Inspection – Validation of Cleaning Processes
• Most Current global regulatory guidelines, such as ASTM, ISPE, PDA TR 29, and other international guidelines
• Current regulatory citation related to cleaning-related deficiencies.

2:00 PM – 2:30 PM

FDA’s Computer Software Assurance for Production and Quality System Software Guidance

Kossi Molley, PMP., LSSBB., Chemist, Sr. Manager, Manufacturing & Operational Excellence, Mivado GlobalPerformance inc (www.mivado.com)

Do you have questions on CSV / CDS validation, and laboratory computerized systems?

Submit or bring your questions for the afternoon Q&A panel Discussions.

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

2:30 PM – 2:45 PM

Mid-Afternoon Refreshment Break

2:45 PM – 3:30 PM

A Practical Approach to Quality Risk Management

Emily Dickinson, Associate Director, Quality Assurance, Linical Americas

• Why is Risk Management Necessary?
• Review of ICH Q9 (R1) Updates
• Building the Structure for an Effective Risk Evaluation Procedure
• Risk Mitigation Versus Risk Management
• Using Experience to Navigate Risk Evaluation
• Not All Risk is Bad Risk: Using Acceptable Risk for Process Improvement

Takeaway Tools

• Outline for an effective risk management procedure

3:30 PM – 4:15 PM

Statistical tools for the detection of trends and deviations

 Steven Walfish, MS, MBA, Statistical Outsourcing Services

4:15 PM – 5:00 PM

Conducting FDA Compliant Out of Specification (OOS) Investigations  

 Dr. Geoff Carr, Pharmaceutical Consultant

Abstract

 It is very important for pharmaceutical QC Labs to have SOPs that thoroughly details how they conduct OOS investigations and these procedures are very likely to be challenged during regulatory inspections. In May 2022, FDA issued a 1st Revision of their OOS Guideline and this session will include a discussion of some key items with some comparisons with a UK MHRA document on this topic. This will be followed by an open discussion during which participants will be invited to present how their various Companies address this important topic.

5:00 PM – 5:30 PM

Afternoon Panel Q&A and Discussions

David W. Vincent, B.Sc., MPH, PhD, Chief Executive Officer (CEO), VTI Life Science

Kossi Molley, PMP., LSSBB., Chemist, Sr. Manager, Manufacturing & Operational Excellence, Mivado GlobalPerformance inc

Kia Kahhali, Founder and CEO, APS Compliance Consultants Inc.

Emily Dickinson, Associate Director, Quality Assurance, Linical Americas

Steven Walfish, MS, MBA, Statistical Outsourcing Services
Dr. Geoff Carr, Pharmaceutical Consultant

5:30 PM

End of day one Conference

TIME

OUTLINE

7:30 AM – 8:30 AM

Registration, Networking and Continental Breakfast

8:30 AM – 8:45 AM

Chair’s Welcome Note – Day 2
Natasha Demberg, President, Demberg PharmaSolutions

8:45 AM – 9:30 AM

LEAN risk based approach for continuous improvement in management of quality deviations and Laboratory investigations.

Jupiter Sene, MBA, MSC,  Senior consultant, QARAPharm Solutions

This presentation will show how to implement a well-designed deviation management system that offers ability to obtaining critical quality data in a timely manner, increase visibility of early warning and potential failure and to enable quick response to failures.  Built a LEAN risk based investigation system that addresses priorities with appropriate efforts to meet the organization’s needs and to deliver optimal results.

9:30 AM – 10:15 AM

The role of leadership and procedures in preventing errors

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

Edwards Deming, the pioneering leader of Toyota in the mid-1900’s, widely regarded as the Father of Modern Quality, said: “85% of the reasons for failure are deficiencies in the systems and process rather than the employee.” Some studies place that number at 95%. Human Error Prevention (HEP) strategy challenges traditional thinking on what causes, and how to prevent, errors and deviations, and helps transform organizations from looking for people’s errors, to finding system flaws and harnessing people for solutions. HEP is a well-researched, well documented field adopted by many industries (e.g. aerospace, nuclear) decades ago. This presentation will focus on two key aspects of HEP – Writing Effective GxP Instructions and Leadership’s Role in Preventing Human Errors. SOPs are the cornerstone of all Quality Management Systems. However, firms tend to write long, text-based procedures. We’ll give an overview of how to approach SOPs differently and create visual, concise, user-friendly procedures. We’ll also look at the many ways leaders can reinforce HEP concepts and help prevent errors.

10:15 AM – 10:30 AM

Mid-morning Refreshment Break & Exhibition viewing

10:30 AM – 11:15 AM

Change Control at Different Stages of Product Lifecycle

Natasha Demberg, President, Demberg PharmaSolutions

Change Control is an integral part of Quality Management System. The question is should we control changes and how do we control them at the different stages of a product’s lifecycle? What is the change and which one should be controlled? We will answer all of the above asked questions during our discussion. In addition, we will learn how to assess the risk of a change using the ICH Q9 and Q10 Guidelines, change of product ownership, and evaluation of the effectiveness of a change.

Takeaways: Change Control process flow and Risk Assessment flow diagrams

11:15 AM – 12:00 PM

Contamination Control Strategy (Compliance Updates – include Annex 1)

David W. Vincent, B.Sc., MPH, PhD, Chief Executive Officer (CEO), VTI Life Science

Agenda Overview

The Contamination Control Strategy (CCS) approach will continuously identify, scientifically evaluate, and effectively control potential contamination risks to product quality. The recent revised EU-Annex-1 elaborates various updated expectations on cleanroom cleaning, disinfection, and decontamination. The expectations defined in EudraLex Volume 4, Annex-1, Aug-2022.

• Contamination Control Strategy (CCS) Risk Assessment
• “CCS” is a key principle area in order to minimize risks of microbial, particulate and endotoxin/pyrogen contamination for the manufacturer of sterile products (Section 2.3)
• Cleanroom Cleaning & Disinfection is a key element as a part of CCS (Section 2.5)
• “Prior cleaning” is a key step of the program to remove surface contamination.
• “Disinfectant Validation” is a Key stage of the Program.

12:00 PM – 12:30 PM

Panel Q&A and Discussions

Jupiter Sene, MBA, MSC,  Senior consultant, QARAPharm Solutions

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

Natasha Demberg, President, Demberg PharmaSolutions

David W. Vincent, B.Sc., MPH, PhD, Chief Executive Officer (CEO), VTI Life Science

12:30 PM – 1:30 PM

Networking Lunch & Exhibition Viewing

1:30 PM – 2:15 PM

Achieving Both; Contamination Control as per Annex 1 and Digitalization of the Environmental Monitoring Process

Ilona Endisch, B.S. in Computer Science, Associate Director, Product Innovations – North America, Novatek International

Abstract: The arrival of the updated Annex 1 is an obvious concern for most.  Many companies in Europe were struggling to update their processes to meet Annex 1 before the deadline. North American companies that do business with Europe must also consider this aspect before making a decision to digitalize – this is a new learning curve for some. At the same time, digitalization is a trending term in the industry that many are looking to understand and incorporate into their infrastructure. Several companies have already created a new position for this role and have provided funding to improve their business models and processes, this over the span of just a couple of years.  We have never before seen so much interest to automate the EM process over the laboratory and chemistry process.  Cleary it has become priority number one for many. 

In today’s presentation, we will focus on the environmental monitoring process and define what digitalization can mean in this respect. We will also cover several points from Annex 1 and demonstrate how best to meet this regulation using examples of a process-based software. Throughout it all, we will discuss a few lessons learned from the industry, companies that are already ahead of the curve in this regard.

2:15 PM – 3:00 PM

Artificial Intelligence in Drug Manufacturing

Kossi Molley, PMP., LSSBB., Chemist, Sr. Manager, Manufacturing & Operational Excellence, Mivado GlobalPerformance inc (www.mivado.com)

3:00 PM – 3:15 PM

TBC

3:15 PM – 3:30 PM

Mid-Afternoon Refreshment Break

3:30 PM – 4:15 PM

Qualification of the Pharmaceutical Supply Chain

Emily Dickinson, Associate Director, Quality Assurance, Linical Americas

• Quality In = Quality Out: Principles of Supply Chain Management
• Building a Robust Supplier Management Program
• Handling Material Changes and Variability
• The Importance of Alternate Suppliers
•  More Than Vials & Stoppers: Effective Shipping and Distribution Management
• Vendor Complaints: Addressing Minor Issues Before They Become Compliance Nightmares

Takeaway Tools

• Outline for a Comprehensive Vendor Questionnaire
• Tips for Working Through Vendor Issues

4:15 PM – 5:00 PM

GMP in Importation, Distribution, and Product Commercialization in Canada

Stuart du Kamp, BSc (Hons), CChem MRSC, PChem, Senior Director, Quality Assurance, AmerisourceBergen, Innomar Strategies Inc

• Overview of Canada’s regulatory importation and distribution regulations.
• The role of the regulatory Importer of Record.
• The Drug Product Commercialization Journey.
• Quality Assurance touchpoints during Product Commercialization.
• Case Study – Canada’s Rollout of COVID-19 Vaccines: A Review of the Collaboration and Services needed to distribute Vaccines Coast-to-Coast-to-Coast amid a Pandemic.
• –  A review of the role Innomar Strategies, FedEx, and Public Health Canada (PHAC) played in the regulatory importation and subsequent distribution of the various COVID vaccines as part of Canada’s response to the pandemic.

5:00 PM – 5:30 PM

Panel Q&A and Discussions

Ilona Endisch, B.S. in Computer Science, Associate Director, Product Innovations – North America, Novatek International

Kossi Molley, PMP., LSSBB., Chemist, Sr. Manager, Manufacturing & Operational Excellence, Mivado GlobalPerformance inc.

Kia Kahhali, Founder and CEO, APS Compliance Consultants Inc.

Emily Dickinson, Associate Director, Quality Assurance, Linical Americas

Stuart du Kamp, BSc (Hons), CChem MRSC, PChem, Senior Director, Quality Assurance, AmerisourceBergen, Innomar Strategies Inc

5:30 PM

Conclusion of Conference