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Agenda

Hands-On Training for Small Molecules, Biologics and Medical Device to Harmonize Global Systems and Enhance Stability Programmes

June 19-21, 2018
  • London, United Kingdom

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, 19 JUNE 2018 PRE-CONFERENCE COURSES

7:30

Pre-Conference Courses and Welcome Refreshments

8:30

Pre-Conference Critical Learning Course

Statistics for the Non Statistician — Foundational Reports, Concrete Tools and Practical Examples for Statistical Modeling

I. Fundamentals

II. Statistical Intervals

III. Comparisons — Hypothesis Tests and ANOVA

IV. Regression — Fitting Equations to Experimental Data

V. Design, Execute and Interpret Regression Analysis

VI. Improve Your Regression Analysis

VII. Measurement Systems Capability

VIII. Introduction to Control Charts

Raul Soto
Senior Principal Engineer
Johnson & Johnson Vision Care

DAY ONE TUESDAY, 19 JUNE 2018 MAIN CONFERENCE

12:00

Main Conference Registration and
Lunch for Pre-Conference Critical Learning Course Attendees

13:15

Conference Welcome and Opening Remarks

Global Regulatory Showcase

13:30

AGES ADDRESS EU GMP Guide — Recent Challenges for the Quality Control Laboratory

Michael Zwitkovits
GMP Inspector
Austrian Federal Office for Safety in Health Care (AGES)

14:30

FDA ADDRESS Analytical Methods for Biological Products

Lokesh Bhattacharyya
Lab Chief, Division of Biological Standard and Quality Control,
Office of Compliance and Biologics Quality,
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration (FDA)

15:30

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual labarotory challenges

16:00

Lessons Learned from FDA Warning Letters to Strengthen Your Programme, Mitigate Risk and Understand How to Stay On Top of Pharmacopoeial Updates to Head off Warning Letters

Karen Ginsbury
BPharm, MSc, Founder and CEO
PCI Pharma Ltd.

17:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, 20 JUNE 2018

8:00

Morning Refreshments

8:30

BYOC — Bring Your Own Challenge Workshop

During this unique workshop, laboratory professionals share their greatest pain points and then collaborate with their stability and method validation counterparts to develop strategies for managing their most pressing challenges. The content for the workshop is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

Lina Patel, PhD
Director, Quality Operations Technical Support
Merck Manufacturing Division

John O’Neill MS, RPh,
Stability Information Specialist
Nagano Science

10:30

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual labarotory challenges

11:00

Conducting Excipient Compatibility Studies (ECS)

I. Pros and Cons of Excipients and Why ECS Studies are Important

II. Types of ECS Study Designs

III. Practical Considerations for Preparing and Testing ECS Study Samples

IV. Interactive Exercise/Study Example

Geoff Carr, PhD
Director, Analytical Development
Thermo Fisher/Patheon Inc

12:30

Networking Luncheon

13:30

User Requirements and Implementation of a Risk-Based, Compliant Stability Management System that Aligns with FDA’s New Data Integrity Draft Guidance

Parsa Famili
President, CEO
Novatek International

15:00

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual labarotory challenges

15:30

Handle OOT Results in Stability Studies

I. OOS, OOT and OOE

II. Understanding OOT Relevance

III. How to Set OOT Alert Limits

IV. How to Identify OOT

V. Special Case – OOT Identification on Degradants and Impurities Data

VI. OOT Investigation Inside the Stability Studies Scope

VII. How to Develop an SOP on OOT Results

VIII. How to Investigate OOT (and OOS) Results

Ricardo Vieira, PharmD
Stability Studies Management Specialist, Quality Department
Bial - Portela & Cª, S. A.

16:30

Close of Day Two

16:30

Stability Testing and Analytical Methods of Hard Cider*

The United Kingdom is the top consumer of cider in the world. Join IVT on a group excursion to Hawkes Cidery & Taproom to apply what you’ve learned over the past two days in a new context – Hard cider production! While you’re sipping a cold glass, ponder questions and discuss cidery challenges.

*Transportation will be provided to and from Hawkes Cidery & Taproom. This event is open to industry only. IVT reserves the right to qualify participants for this outing.

DAY THREE THURSDAY, 21 JUNE 2018

8:00

Morning Refreshments

8:30-10:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)

SESSION 1 Senior-Level Think Tank — Risk Management as a Useful Laboratory Activity (Rather Than a Check Box Activity)*

This highly popular session is in the hands of the participants. Addressing the questions below, the participants develop the discussion with Karen facilitating the topics so that there is maximum opportunity for benchmarking and knowledge sharing.

Frustrated by the amount of time expended on risk assessments or is the area neglected in your laboratory? Want to know what others are doing and how to simplify and make the process value added? Want to share a best practice? This is the session for you.

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharma Ltd.

*IVT reserves the right to qualify participants for this session.

SESSION 2 Container Systems for Peptide API with Metal Chelators

I. Selecting Containers

II. Stability Studies

III. Interactive Exercise

Gareth Murphy
Senior Analytical Development Chemist
Ipsen Manufacturing Ireland Ltd.

10:00

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual labarotory challenges

10:30

Getting the Most Out of Outsourced Testing — Managing Contract Laboratories

I. Regulations, Guidance and Current Inspectional Issues

II. Risk Management

III. Interactive Exercise

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharma Ltd.

12:00

Networking Luncheon

13:00

Calculation of Internal Release Limits (IRL) for your Pharmaceutical Drug Product

I. Degradation Rate

II. Advanced Methods — Bayesian Statistics

III. IRL and Biological Products

Laurent Natalis, PhD
Senior Manager, Statistics
Arlenda (a PharmaLex company)

14:30

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual labarotory challenges

15:00

Mitigating Data Integrity Risk in Analytical Methods and Stability Testing

I. Regulations, Guidance and Current Inspectional Issues

II. Mitigation — P-D-C-A

III. Interactive Exercise

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharma Ltd.

16:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, 19 JUNE 2018 PRE-CONFERENCE COURSES

7:30

Pre-Conference Courses and Welcome Refreshments

8:30

Pre-Conference Critical Learning Course

Statistics for the Non Statistician — Foundational Reports, Concrete Tools and Practical Examples for Statistical Modeling

I. Fundamentals

II. Statistical Intervals

III. Comparisons — Hypothesis Tests and ANOVA

IV. Regression — Fitting Equations to Experimental Data

V. Design, Execute and Interpret Regression Analysis

VI. Improve Your Regression Analysis

VII. Measurement Systems Capability

VIII. Introduction to Control Charts

Raul Soto
Senior Principal Engineer
Johnson & Johnson Vision Care

DAY ONE TUESDAY, 19 JUNE 2018 MAIN CONFERENCE

12:00

Main Conference Registration and
Lunch for Pre-Conference Critical Learning Course Attendees

13:15

Conference Welcome and Opening Remarks

Global Regulatory Showcase

13:30

AGES ADDRESS EU GMP Guide — Recent Challenges for the Quality Control Laboratory

Michael Zwitkovits
GMP Inspector
Austrian Federal Office for Safety in Health Care (AGES)

14:30

FDA ADDRESS Analytical Methods for Biological Products

Lokesh Bhattacharyya
Lab Chief, Division of Biological Standard and Quality Control,
Office of Compliance and Biologics Quality,
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration (FDA)

15:30

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual labarotory challenges

16:00

Lessons Learned from FDA Warning Letters to Strengthen Your Programme, Mitigate Risk and Understand How to Stay On Top of Pharmacopoeial Updates to Head off Warning Letters

Karen Ginsbury
BPharm, MSc, Founder and CEO
PCI Pharma Ltd.

17:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, 20 JUNE 2018

8:00

Morning Refreshments

8:30

BYOC — Bring Your Own Challenge Workshop

During this unique workshop, laboratory professionals share their greatest pain points and then collaborate with their stability and method validation counterparts to develop strategies for managing their most pressing challenges. The content for the workshop is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

Lina Patel, PhD
Director, Quality Operations Technical Support
Merck Manufacturing Division

John O’Neill MS, RPh,
Stability Information Specialist
Nagano Science

10:30

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual labarotory challenges

11:00

Conducting Excipient Compatibility Studies (ECS)

I. Pros and Cons of Excipients and Why ECS Studies are Important

II. Types of ECS Study Designs

III. Practical Considerations for Preparing and Testing ECS Study Samples

IV. Interactive Exercise/Study Example

Geoff Carr, PhD
Director, Analytical Development
Thermo Fisher/Patheon Inc

12:30

Networking Luncheon

13:30

User Requirements and Implementation of a Risk-Based, Compliant Stability Management System that Aligns with FDA’s New Data Integrity Draft Guidance

Parsa Famili
President, CEO
Novatek International

15:00

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual labarotory challenges

15:30

Handle OOT Results in Stability Studies

I. OOS, OOT and OOE

II. Understanding OOT Relevance

III. How to Set OOT Alert Limits

IV. How to Identify OOT

V. Special Case – OOT Identification on Degradants and Impurities Data

VI. OOT Investigation Inside the Stability Studies Scope

VII. How to Develop an SOP on OOT Results

VIII. How to Investigate OOT (and OOS) Results

Ricardo Vieira, PharmD
Stability Studies Management Specialist, Quality Department
Bial - Portela & Cª, S. A.

16:30

Close of Day Two

16:30

Stability Testing and Analytical Methods of Hard Cider*

The United Kingdom is the top consumer of cider in the world. Join IVT on a group excursion to Hawkes Cidery & Taproom to apply what you’ve learned over the past two days in a new context – Hard cider production! While you’re sipping a cold glass, ponder questions and discuss cidery challenges.

*Transportation will be provided to and from Hawkes Cidery & Taproom. This event is open to industry only. IVT reserves the right to qualify participants for this outing.

DAY THREE THURSDAY, 21 JUNE 2018

8:00

Morning Refreshments

8:30-10:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)

SESSION 1 Senior-Level Think Tank — Risk Management as a Useful Laboratory Activity (Rather Than a Check Box Activity)*

This highly popular session is in the hands of the participants. Addressing the questions below, the participants develop the discussion with Karen facilitating the topics so that there is maximum opportunity for benchmarking and knowledge sharing.

Frustrated by the amount of time expended on risk assessments or is the area neglected in your laboratory? Want to know what others are doing and how to simplify and make the process value added? Want to share a best practice? This is the session for you.

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharma Ltd.

*IVT reserves the right to qualify participants for this session.

SESSION 2 Container Systems for Peptide API with Metal Chelators

I. Selecting Containers

II. Stability Studies

III. Interactive Exercise

Gareth Murphy
Senior Analytical Development Chemist
Ipsen Manufacturing Ireland Ltd.

10:00

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual labarotory challenges

10:30

Getting the Most Out of Outsourced Testing — Managing Contract Laboratories

I. Regulations, Guidance and Current Inspectional Issues

II. Risk Management

III. Interactive Exercise

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharma Ltd.

12:00

Networking Luncheon

13:00

Calculation of Internal Release Limits (IRL) for your Pharmaceutical Drug Product

I. Degradation Rate

II. Advanced Methods — Bayesian Statistics

III. IRL and Biological Products

Laurent Natalis, PhD
Senior Manager, Statistics
Arlenda (a PharmaLex company)

14:30

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual labarotory challenges

15:00

Mitigating Data Integrity Risk in Analytical Methods and Stability Testing

I. Regulations, Guidance and Current Inspectional Issues

II. Mitigation — P-D-C-A

III. Interactive Exercise

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharma Ltd.

16:30

Close of Conference