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DAY ONE TUESDAY, 28 MARCH 2017

12:00

Conference Registration

13:15

Chairperson’s Welcome and Opening Remarks

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT Network/UBM Life Sciences;
Associate Professor of Biopharmaceutics
University of Illinois at Chicago (UIC) College of Pharmacy

13:3015:00

90-MINUTE SESSION

Data Integrity —
Trends, Issues and Challenges

With 6 regulatory guidances issued either as drafts or finalised since January 2015, the topic of Data Integrity and Data Governance is overwhelming regulators and industry alike. MHRA, WHO, FDA, PIC/s, EMA have all issued guides and countless warning letters touching on almost every aspect of pharmaceutical manufacturing, testing and allied processes.

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd.

15:00

Networking and Refreshment Break

15:3017:00

90-MINUTE SESSION

Ensure Data Integrity in Computer Systems

I. Understand the Data Integrity Lifecycle

II. What Is Data Security?

III. What Is Electronic Record/ Electronic Signature (ER/ES)?

IV. Controls for Electronic Data

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

17:00

Close of Day One

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

DAY TWO WEDNESDAY, 29 MARCH 2017

7:15

Coffee and Biscuits

7:30

EYE-OPENER BREAKFAST DISCUSSION Risk-Based Validation —
Reduce Data Integrity Risks and Enhance Reliability of Results

How is industry integrating data integrity controls into system and process design? (Are they doing it?) How is the design qualified and after installation validated for data integrity? Have we got a handle on a risk-based approach to validation and does it address the enhanced reliability of results?

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd.

8:3010:00

90-MINUTE SESSION

Overcome Data Integrity Challenges in a Regulated Environment — Valuable Insight from Practical Experiences

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

10:00

Networking and Refreshment Break

10:3012:00

90-MINUTE SESSION

Data Integrity Think Tank —
Benchmark against Your Peers

In this highly interactive summit life science professionals working in the analytical laboratory engage in open discussions with their colleagues about strategies for managing their most pressing data integrity challenges. The content for the session is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd.

12:00

Networking Luncheon

13:0014:30

90-MINUTE SESSION

Conduct a Company-Wide Data Integrity
Gap Analysis and Internal Audit

I. Regulations, Warning Letters and 483 and Guidance

II. Interactive Exercise 1 — Create a Gap Analysis Checklist

III. Interactive Exercise 2 — Internal Audit versus Gap Analysis

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd.

14:30

Networking and Refreshment Break

15:0016:30

90-MINUTE SESSION

Auditing the Audit Trails —
Key Elements to Define and Track Your Data

Have you considered that the new requirements for reviewing audit trails could actually save you time in the long run? This session clarifies the new requirements for audit trails, then provides you with recommendations for how you can not only implement these new requirements but also use them to speed up QA review and automate data collection tasks.

Ty Mew
President
Ofni Systems

16:30

Close of Day Two

DAY THREE THURSDAY, 30 MARCH 2017

7:15

Coffee and Biscuits

7:30

EYE-OPENER BREAKFAST DISCUSSION Are Your Vendors in Data Integrity Compliance? — Approaches to Auditing Software Vendors Using Agile SDLC Methodologies

With the advent of new Software Development Life Cycle (SDLC) methodologies, such as Agile, software vendors have changed their approaches to developing software significantly over the last 10 years, including how software development is managed and documented. In the case that software vendors also provide Software-as-a- Service (SaaS) capabilities to their clients, the risk to regulated companies increases significantly if the vendor’s quality system and SDLC processes are not adequately evaluated during an audit. These new processes require new approaches and expectations when auditing software vendors.

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

8:3010:00

90-MINUTE SESSION

Educate for Data Governance — Implement an Effective, Multi-Dimensional Training Program

I. THE WHO — Educate Key Stakeholders on Your Organisation’s Data Governance

II. THE WHAT — Identify the Scope of Education for Data Governance

III. THE WHERE — Right-Size Education Requirements for Data and Information Governance

IV. THE WHEN — Determine the Timing and Frequency of Education for Data Governance

V. THE WHY — Define Goals for Knowledge Management and Organisational Learning

VI. THE HOW — Use a Blended Training Approach to Support a Continuous Learning Strategy

VII. Interactive Exercise

Willis H. Thomas, PhD, PMP, CPT
Director of Training
Akorn Pharmaceuticals

10:00

Networking and Refreshment Break

10:3012:00

90-MINUTE SESSION

Standing Tall Despite Data Integrity Shortfalls —
The Effective Use of CAPA When Things Go Wrong

I. Data Integrity — What Does This Mean to the Industry?

II. Data Integrity Shortfalls and Challenges

III. Effective Use of CAPAs for Corrective Data Integrity Shortfalls

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis Systems

12:00

Networking Luncheon

13:0014:30

90-MINUTE SESSION

Data Migration and Verification — Validation Strategies when Transferring Data from Legacy Systems

I. Data Integrity Overview

II. We Need to Upgrade! What Do We Do with Our Data?

III. Data Migration Governance

IV. Data Migration Testing

V. Case Study #1

VI. Case Study #2

Raul Soto, MsSc, BsME, CQE
Principal Engineer
Johnson & Johnson Vision Care

14:30

Networking and Refreshment Break

15:0016:30

90-MINUTE SESSION

Safeguard Data —
Risk-Based Cyber Security

I. Risk Assessment — Vulnerability

II. Information Security

III. Environmental Security

IV. Cybersecurity

V. Physical Security

Willis H. Thomas, PhD, PMP, CPT
Director of Training
Akorn Pharmaceuticals

16:30

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, 28 MARCH 2017

12:00

Conference Registration

13:15

Chairperson’s Welcome and Opening Remarks

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and Journal of GXP Compliance
IVT Network/UBM Life Sciences;
Associate Professor of Biopharmaceutics
University of Illinois at Chicago (UIC) College of Pharmacy

13:3015:00

90-MINUTE SESSION

Data Integrity —
Trends, Issues and Challenges

With 6 regulatory guidances issued either as drafts or finalised since January 2015, the topic of Data Integrity and Data Governance is overwhelming regulators and industry alike. MHRA, WHO, FDA, PIC/s, EMA have all issued guides and countless warning letters touching on almost every aspect of pharmaceutical manufacturing, testing and allied processes.

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd.

15:00

Networking and Refreshment Break

15:3017:00

90-MINUTE SESSION

Ensure Data Integrity in Computer Systems

I. Understand the Data Integrity Lifecycle

II. What Is Data Security?

III. What Is Electronic Record/ Electronic Signature (ER/ES)?

IV. Controls for Electronic Data

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

17:00

Close of Day One

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

DAY TWO WEDNESDAY, 29 MARCH 2017

7:15

Coffee and Biscuits

7:30

EYE-OPENER BREAKFAST DISCUSSION Risk-Based Validation —
Reduce Data Integrity Risks and Enhance Reliability of Results

How is industry integrating data integrity controls into system and process design? (Are they doing it?) How is the design qualified and after installation validated for data integrity? Have we got a handle on a risk-based approach to validation and does it address the enhanced reliability of results?

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd.

8:3010:00

90-MINUTE SESSION

Overcome Data Integrity Challenges in a Regulated Environment — Valuable Insight from Practical Experiences

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

10:00

Networking and Refreshment Break

10:3012:00

90-MINUTE SESSION

Data Integrity Think Tank —
Benchmark against Your Peers

In this highly interactive summit life science professionals working in the analytical laboratory engage in open discussions with their colleagues about strategies for managing their most pressing data integrity challenges. The content for the session is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd.

12:00

Networking Luncheon

13:0014:30

90-MINUTE SESSION

Conduct a Company-Wide Data Integrity
Gap Analysis and Internal Audit

I. Regulations, Warning Letters and 483 and Guidance

II. Interactive Exercise 1 — Create a Gap Analysis Checklist

III. Interactive Exercise 2 — Internal Audit versus Gap Analysis

Karen Ginsbury, BPharm, MSc
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd.

14:30

Networking and Refreshment Break

15:0016:30

90-MINUTE SESSION

Auditing the Audit Trails —
Key Elements to Define and Track Your Data

Have you considered that the new requirements for reviewing audit trails could actually save you time in the long run? This session clarifies the new requirements for audit trails, then provides you with recommendations for how you can not only implement these new requirements but also use them to speed up QA review and automate data collection tasks.

Ty Mew
President
Ofni Systems

16:30

Close of Day Two

DAY THREE THURSDAY, 30 MARCH 2017

7:15

Coffee and Biscuits

7:30

EYE-OPENER BREAKFAST DISCUSSION Are Your Vendors in Data Integrity Compliance? — Approaches to Auditing Software Vendors Using Agile SDLC Methodologies

With the advent of new Software Development Life Cycle (SDLC) methodologies, such as Agile, software vendors have changed their approaches to developing software significantly over the last 10 years, including how software development is managed and documented. In the case that software vendors also provide Software-as-a- Service (SaaS) capabilities to their clients, the risk to regulated companies increases significantly if the vendor’s quality system and SDLC processes are not adequately evaluated during an audit. These new processes require new approaches and expectations when auditing software vendors.

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

8:3010:00

90-MINUTE SESSION

Educate for Data Governance — Implement an Effective, Multi-Dimensional Training Program

I. THE WHO — Educate Key Stakeholders on Your Organisation’s Data Governance

II. THE WHAT — Identify the Scope of Education for Data Governance

III. THE WHERE — Right-Size Education Requirements for Data and Information Governance

IV. THE WHEN — Determine the Timing and Frequency of Education for Data Governance

V. THE WHY — Define Goals for Knowledge Management and Organisational Learning

VI. THE HOW — Use a Blended Training Approach to Support a Continuous Learning Strategy

VII. Interactive Exercise

Willis H. Thomas, PhD, PMP, CPT
Director of Training
Akorn Pharmaceuticals

10:00

Networking and Refreshment Break

10:3012:00

90-MINUTE SESSION

Standing Tall Despite Data Integrity Shortfalls —
The Effective Use of CAPA When Things Go Wrong

I. Data Integrity — What Does This Mean to the Industry?

II. Data Integrity Shortfalls and Challenges

III. Effective Use of CAPAs for Corrective Data Integrity Shortfalls

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis Systems

12:00

Networking Luncheon

13:0014:30

90-MINUTE SESSION

Data Migration and Verification — Validation Strategies when Transferring Data from Legacy Systems

I. Data Integrity Overview

II. We Need to Upgrade! What Do We Do with Our Data?

III. Data Migration Governance

IV. Data Migration Testing

V. Case Study #1

VI. Case Study #2

Raul Soto, MsSc, BsME, CQE
Principal Engineer
Johnson & Johnson Vision Care

14:30

Networking and Refreshment Break

15:0016:30

90-MINUTE SESSION

Safeguard Data —
Risk-Based Cyber Security

I. Risk Assessment — Vulnerability

II. Information Security

III. Environmental Security

IV. Cybersecurity

V. Physical Security

Willis H. Thomas, PhD, PMP, CPT
Director of Training
Akorn Pharmaceuticals

16:30

Close of Conference