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
13:30–15:00
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
15:30–17:00
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.
8:30–10:00
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
10:30–12:00
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
13:00–14:30
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
15:00–16:30
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
8:30–10:00
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
10:30–12:00
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
13:00–14:30
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
15:00–16:30
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
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
13:30–15:00
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
15:30–17:00
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.
8:30–10:00
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
10:30–12:00
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
13:00–14:30
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
15:00–16:30
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
8:30–10:00
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
10:30–12:00
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
13:00–14:30
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
15:00–16:30
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
