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Agenda

Proactive GxP Strategies • Audit Trail Review • Laboratory Assessments • Robust CAPA • Gap Analysis

December 4-6, 2017
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE MONDAY, DECEMBER 4, 2017

7:30

Pre-Conference Registration and Continental Breakfast

8:30 – 12:00

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS (A-B)

WORKSHOP A Mitigating Data Integrity Risk in Analytical Methods and Stability Testing

I. Laboratory Data Integrity Issues Found in Audits and Inspections

II. Implement Electronic Controls around Data Integrity

III. Interactive Exercise

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

 
WORKSHOP B Lifecycle Management in the Laboratory

I. Regulations, Requirements, Guidelines, Standards and Expectations

II. Lifecycle Management in the Laboratory

III. Use of Risk Management in Analytical Lifecycle

IV. Interactive Exercise

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

There will be a Networking and Refreshment Break at 10:00am

MAIN CONFERENCE MONDAY, DECEMBER 4, 2017

12:00

Conference Registration

1:00

Chairperson’s Welcome and Opening Remarks

Beth McCullough
Director, Quality and Risk Management
GlaxoSmithKline

1:15

REGULATORY SNAPSHOT Regulatory Guidances in Analytical Methods, Stability Testing and Lifecycle Laboratory Management

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

2:45

Office Hours & Networking and Refreshment Break

3:15

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

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

4:00

60-MINUTE SESSION

Performing Data Integrity Gap Analysis within the Laboratory

I. Data Integrity in GMP Laboratories

II. Determine the Scope and the Assessment Process

III. Assessments Tools

IV. Data Analysis and Risk Prioritization

V. Robust Quality System for Early Detection

Paresh Patel, MS
Director, Lab Scientific Operations
Johnson & Johnson

5:00

Close of Day One

Networking, Wine and Cheese Reception (immediately following the close of day one)

DAY TWO TUESDAY, DECEMBER 5, 2017

7:30

Continental Breakfast

8:30 – 10:00

90-MINUTE SESSION

Writing Master Validation Plans

Validation projects can be complicated, but are you making the job more difficult by continuing to use outdated documentation standards? This session dives into the best practices for documentation that can be easily understood, approved and executed while enhancing the auditability of the package for regulatory review. We look at every task and deliverable to help you find ways to improve areas such as training, requirements definition, communication, execution and deviation resolution.

Ty Mew
President
Ofni Systems

10:00

Office Hours & Networking and Refreshment Break

10:30 – 12:00

90-MINUTE SESSION

ELN and LIMS Case Study Benefits and Challenges of Managing Sample Workflows in the Laboratory

I. Current Sample Management Challenges in a Modern Laboratory

II. Implementation and Benefits

III. Live Demonstration

Shelby Lorenz
Senior Informatics Business Development Specialist
Waters

Mario Rossi
Manager, Informatics Business Development
Waters

Tom Lawson
Vice President, Quality Operations and Food Safety
VitaQuest International LLC

12:00

Networking Luncheon

1:00 – 2:30

90-MINUTE SESSION

Cultural Transformation —
Strengthen Organizational Ethics to Improve Data Integrity

I. Ethical Dilemmas

II. Leadership, Personal Example and Education

III. Interactive Exercise

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

2:30

Office Hours & Networking and Refreshment Break

3:00

CASE STUDY Overcome the Challenges of Paperless Implementations

Ed Eirikis
Computer Validation and Compliance Manager
Janssen BioTherapeutics

4:00

Close of Day Two

DAY THREE WEDNESDAY, DECEMBER 6, 2017

7:30

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

SESSION 1 LIVE DATA CAPTURE Senior-Level Think Tank — Analytical Integrity*

This session is owned by the delegates. It is intended for personnel with a minimum of ten years’ experience in industry and is an opportunity to exchange views, benchmark and share best practices with other professionals. Key learnings are captured live and then sent out to participants.

The think tank is focused on ways in which companies are strengthening their overall analytical integrity, through discussion of the four requisites for data integrity in the QC laboratory.

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

SESSION 2 Integrity in Motion — The Value of Data Integrity

I. Understanding Integrity and Making a Plan

II. Process Mapping and Recognizing Risk

III. Making Data Integrity Pay for Itself

IV. Interactive Exercise

Josh Billington
Laboratory Application Analyst
EAG Inc.

Diana Mayes
Manager, Validation
EAG Inc.

10:00

Office Hours & Networking and Refreshment Break

10:30 – 11:15

AUDITOR PERSPECTIVE Outside Optics — From Upstream Development to Operations

An auditor has an advantage of viewing the “full picture” of an organization’s processes, the interaction between processes and the sequence of process steps to ensure effectiveness of the system from inception to commercialization. This session provides attendees with the perspective that auditors have in following an audit trail from upstream development, including research and development, to project engineering and management and to operations.

11:15 – 12:00

Let’s Bootstrap!
An Iterative Approach to Effective Training for Data Integrity

Yes, there are many 21 CFR 11 compliant laboratory data systems available, but how do they affect laboratory workflow? A simplistic approach to training involves training employees on the requirements for data integrity, the need for controlled software, and then training on the controls and use of the software. Our newly trained employees are then sent into the laboratory where they are confronted with software documentation issues and multiple deviations which result in decreased workflow. What was once a routine and streamlined procedure has now been interrupted by the implementation of an additional process. This session focuses on the use of feedback loops for data integrity compliance utilizing active engagement of laboratory and quality staff. Can we work together to build a self-sustaining system that promotes continual improvement?

Amy L. Lachapelle
Founder, Lead Consultant
QBD Strategies LLC

12:00

Networking Luncheon

1:00 – 2:30

90-MINUTE SESSION

Steps for Implementing a Robust CAPA Program for Data Integrity Non-Compliance

I. The Iceberg — Get Below the Water Line to the True Source of Non-Compliance

II. Develop the Right CAPAs to Correct and Prevent Future Occurrences

III. Use Effectiveness Checks to Confirm that the Appropriate CAPAs were Implemented

IV. Interactive Exercise

Beth McCullough
Director, Quality and Risk Management
GlaxoSmithKline

2:30

Office Hours & Networking and Refreshment Break

3:00 – 4:30

90-MINUTE SESSION

Improve User Training to Minimize Risk of User Work-Arounds

I. Identify Work-Around Risk

II. Elevate Process to Mitigate Risk

Speaker TBA

4:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE MONDAY, DECEMBER 4, 2017

7:30

Pre-Conference Registration and Continental Breakfast

8:30 – 12:00

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS (A-B)

WORKSHOP A Mitigating Data Integrity Risk in Analytical Methods and Stability Testing

I. Laboratory Data Integrity Issues Found in Audits and Inspections

II. Implement Electronic Controls around Data Integrity

III. Interactive Exercise

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

 
WORKSHOP B Lifecycle Management in the Laboratory

I. Regulations, Requirements, Guidelines, Standards and Expectations

II. Lifecycle Management in the Laboratory

III. Use of Risk Management in Analytical Lifecycle

IV. Interactive Exercise

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

There will be a Networking and Refreshment Break at 10:00am

MAIN CONFERENCE MONDAY, DECEMBER 4, 2017

12:00

Conference Registration

1:00

Chairperson’s Welcome and Opening Remarks

Beth McCullough
Director, Quality and Risk Management
GlaxoSmithKline

1:15

REGULATORY SNAPSHOT Regulatory Guidances in Analytical Methods, Stability Testing and Lifecycle Laboratory Management

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

2:45

Office Hours & Networking and Refreshment Break

3:15

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

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

4:00

60-MINUTE SESSION

Performing Data Integrity Gap Analysis within the Laboratory

I. Data Integrity in GMP Laboratories

II. Determine the Scope and the Assessment Process

III. Assessments Tools

IV. Data Analysis and Risk Prioritization

V. Robust Quality System for Early Detection

Paresh Patel, MS
Director, Lab Scientific Operations
Johnson & Johnson

5:00

Close of Day One

Networking, Wine and Cheese Reception (immediately following the close of day one)

DAY TWO TUESDAY, DECEMBER 5, 2017

7:30

Continental Breakfast

8:30 – 10:00

90-MINUTE SESSION

Writing Master Validation Plans

Validation projects can be complicated, but are you making the job more difficult by continuing to use outdated documentation standards? This session dives into the best practices for documentation that can be easily understood, approved and executed while enhancing the auditability of the package for regulatory review. We look at every task and deliverable to help you find ways to improve areas such as training, requirements definition, communication, execution and deviation resolution.

Ty Mew
President
Ofni Systems

10:00

Office Hours & Networking and Refreshment Break

10:30 – 12:00

90-MINUTE SESSION

ELN and LIMS Case Study Benefits and Challenges of Managing Sample Workflows in the Laboratory

I. Current Sample Management Challenges in a Modern Laboratory

II. Implementation and Benefits

III. Live Demonstration

Shelby Lorenz
Senior Informatics Business Development Specialist
Waters

Mario Rossi
Manager, Informatics Business Development
Waters

Tom Lawson
Vice President, Quality Operations and Food Safety
VitaQuest International LLC

12:00

Networking Luncheon

1:00 – 2:30

90-MINUTE SESSION

Cultural Transformation —
Strengthen Organizational Ethics to Improve Data Integrity

I. Ethical Dilemmas

II. Leadership, Personal Example and Education

III. Interactive Exercise

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

2:30

Office Hours & Networking and Refreshment Break

3:00

CASE STUDY Overcome the Challenges of Paperless Implementations

Ed Eirikis
Computer Validation and Compliance Manager
Janssen BioTherapeutics

4:00

Close of Day Two

DAY THREE WEDNESDAY, DECEMBER 6, 2017

7:30

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

SESSION 1 LIVE DATA CAPTURE Senior-Level Think Tank — Analytical Integrity*

This session is owned by the delegates. It is intended for personnel with a minimum of ten years’ experience in industry and is an opportunity to exchange views, benchmark and share best practices with other professionals. Key learnings are captured live and then sent out to participants.

The think tank is focused on ways in which companies are strengthening their overall analytical integrity, through discussion of the four requisites for data integrity in the QC laboratory.

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

SESSION 2 Integrity in Motion — The Value of Data Integrity

I. Understanding Integrity and Making a Plan

II. Process Mapping and Recognizing Risk

III. Making Data Integrity Pay for Itself

IV. Interactive Exercise

Josh Billington
Laboratory Application Analyst
EAG Inc.

Diana Mayes
Manager, Validation
EAG Inc.

10:00

Office Hours & Networking and Refreshment Break

10:30 – 11:15

AUDITOR PERSPECTIVE Outside Optics — From Upstream Development to Operations

An auditor has an advantage of viewing the “full picture” of an organization’s processes, the interaction between processes and the sequence of process steps to ensure effectiveness of the system from inception to commercialization. This session provides attendees with the perspective that auditors have in following an audit trail from upstream development, including research and development, to project engineering and management and to operations.

11:15 – 12:00

Let’s Bootstrap!
An Iterative Approach to Effective Training for Data Integrity

Yes, there are many 21 CFR 11 compliant laboratory data systems available, but how do they affect laboratory workflow? A simplistic approach to training involves training employees on the requirements for data integrity, the need for controlled software, and then training on the controls and use of the software. Our newly trained employees are then sent into the laboratory where they are confronted with software documentation issues and multiple deviations which result in decreased workflow. What was once a routine and streamlined procedure has now been interrupted by the implementation of an additional process. This session focuses on the use of feedback loops for data integrity compliance utilizing active engagement of laboratory and quality staff. Can we work together to build a self-sustaining system that promotes continual improvement?

Amy L. Lachapelle
Founder, Lead Consultant
QBD Strategies LLC

12:00

Networking Luncheon

1:00 – 2:30

90-MINUTE SESSION

Steps for Implementing a Robust CAPA Program for Data Integrity Non-Compliance

I. The Iceberg — Get Below the Water Line to the True Source of Non-Compliance

II. Develop the Right CAPAs to Correct and Prevent Future Occurrences

III. Use Effectiveness Checks to Confirm that the Appropriate CAPAs were Implemented

IV. Interactive Exercise

Beth McCullough
Director, Quality and Risk Management
GlaxoSmithKline

2:30

Office Hours & Networking and Refreshment Break

3:00 – 4:30

90-MINUTE SESSION

Improve User Training to Minimize Risk of User Work-Arounds

I. Identify Work-Around Risk

II. Elevate Process to Mitigate Risk

Speaker TBA

4:30

Close of Conference