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Agenda

Hands-On Training for Small Molecules, Biologics and Medical Device to Harmonize Global Systems and Conduct Effective Analytical Method Transfers

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
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

Establish a Lifecycle Approach for Method Validation and Determine Phase Appropriate Activities

I. Analytical Method Validation

II. Method Validation Process

III. Method Validation Implementation

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

12:30

Networking Luncheon

13:30

Integrating a Data Integrity Compliance Plan into Your Organisation’s DNA

I. Develop Data Integrity Processes to Ensure Compliance

II. Improve Training and Streamline Solutions

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

15:00

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

15:30

Method Validation vs. Method Transfer vs. Implementation of Pharmacopoeial Methods — The European Perspective

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

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, Ph.D.
Senior Manager Statistics
Arlenda (PharmaLex)

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
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

Establish a Lifecycle Approach for Method Validation and Determine Phase Appropriate Activities

I. Analytical Method Validation

II. Method Validation Process

III. Method Validation Implementation

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

12:30

Networking Luncheon

13:30

Integrating a Data Integrity Compliance Plan into Your Organisation’s DNA

I. Develop Data Integrity Processes to Ensure Compliance

II. Improve Training and Streamline Solutions

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

15:00

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

15:30

Method Validation vs. Method Transfer vs. Implementation of Pharmacopoeial Methods — The European Perspective

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

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, Ph.D.
Senior Manager Statistics
Arlenda (PharmaLex)

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