IT and Computerized Systems Validation Week

R E G I S T E R B Y F E B R U A R Y 7 , 2 0 2 0 T O S AV E $ 3 0 0 !

KEYNOTE

Cybersecurity and Compliance —

The Future of Validation in GxP Systems

CRITICAL UPDATE

Moving Towards Pharma 4.0

SPOTLIGHT SESSION

Audit Trail Reviews for Data Integrity —

Risk Mitigation and the Audit Trail Checklist

FIRESIDE CONVERSATION

FDA/Industry Collaboration on

Computer Software Assurance (CSA)

21st Annual

IT and Computerized Systems Validation Week

Robust Knowledge Exchange Addressing the Complexities of System Integration, Computer Validation and FDA Readiness

APRIL 29 – MAY 1, 2020 HILTON AT PENN’S LANDING

PHILADELPHIA, PA

21ST ANNUAL

APRIL 29 – MAY 1, 2020 • HILTON AT PENN’S LANDING • PHILADELPHIA, PA

ITand Computerized Systems Validation WeekRobust Knowledge Exchange Addressingthe Complexities of System Integration,Computer Validation and FDA Readiness

FEATURING LEADING INDUSTRY PERSPECTIVES FROM:Allergan • Dr. Reddy’s Laboratories • Gilead • GlaxoSmithKline • ICU Medical Jazz Pharmaceuticals • Johnson & Johnson VisionCare • Mallinckrodt • Medtronic Merck • Orchard Therapeutics • Sage Therapeutics • Sanofi • Servier Pharma • Takeda

A. Cloud Computing and Data Integrity Validation B. Quality Assurance/Quality by Design

CUSTOMIZE YOUR EXPERIENCE AND SELECT AMONG TWO TRACKS

MEDIA PARTNERS:

R E G I S T E R AT W W W.C B I N E T.C O M /C SV • 8 0 0 - 8 1 7 - 8 6 0 1

A division ofUBM Americas

Brought to you by Informa Connect

IT/Systems

Validation/CSV

Quality/QA/QC

See Who Attends Paving the Way to Validation Excellence

Need access to current regulations and guidance documents, timely news and trending technologies? IVT Network is your #1 supplier of validation and compliance resources including peer reviewed journals, eBooks and latest best practices.

Members receive access to all online materials, plus enjoy being on the pulse of the industry through our frequent blogs and podcasts. Want to learn more? Visit IVTNetwork.com or email [email protected].

A Great Place to Meet Your Market IVT’s IT and Computerized Systems Validation Week convenes the life sciences industry’s leading experts responsible for implementing, managing and driving their organization’s quality, IT and validation programs. Capitalize on the opportunity to network, exchange ideas and share solutions throughout the conference. For more information, contact Steve Markos at +1 339-298-2108 or email at [email protected].

Engineering

Compliance

26%

24%21%

21%

8%

Optimize Opportunities for Connecting and Benchmarking

Conference Sponsor:



3

Dan Dziadiw, Director IT Compliance and Risk, Merck

Frankie Bill, IT Manager - QA Governance, Medtronic

John H. Adams, Jr., Computer Systems Validation Lead, Spark Therapeutics, Inc.

Joseph Zec, Associate Director, CSV and Compliance, Takeda

Ken Shitamoto, MS, Senior Director, IT, Gilead Sciences

Raechelle Raimondo, Executive Director, Global IT Systems Assurance and Compliance, Allergan

Ravi Yalamanchili, Director Computer Systems Quality & Data Integrity, Juno Therapeutics

Senthil Gurumoorthi, Associate Director, IT Quality Assurance, Gilead Sciences

Thank You to the 2020 Advisory Board:

Bhaskar Aryasomayajula, Senior Manager, Computer Systems Validation, Mallinckrodt

Frankie Bill, IT Manager – QA Governance, Medtronic

Sanat K. Bose, Senior Director, Global CSV & QA, Shionogi Inc.

Brian DiVasta, Associate Director, ITS Compliance, Sanofi

Dan Dziadiw, Director IT Compliance and Risk, Merck

Eileen Cortes, EIT, MBA, Director, QA Global Validation, BioMarin (invited)

Joanne Goldberg, Senior Principal IT Business Systems Analyst, Medtronic

Senthil Gurumoorthi, Associate Director, Gilead Sciences

Pat Hebert, Head of Quality – Digital/Data Compliance, Biologics, Sanofi

Leslie Lighton-Humphries, IT SQA & CSV Manager, AmerisourceBergen

Sandra Liu, Head of IT Validation, Compliance and Assurance (Director), Jazz Pharmaceuticals

Orlando Lopez, E-compliance and E-records SME

Nathan McBride, Vice President, Information Technology, Ohana Biosciences, Inc.

Cynthia Pleach, Manager, Quality Assurance IT, Sage Therapeutics

Deepak Saini, Director IT, Dr. Reddy’s Laboratories

Raechelle Raimondo, Executive Director, Global IT Systems Assurance and Compliance, Allergan

Ken Shitamoto, MS, Senior Director, IT, Gilead Sciences

Raul Soto, Senior Principal Software Quality Engineer, Johnson & Johnson Vision Care

Anu Virkar, PMP, Head of Quality and Compliance Watson Health LS, IBM

Robert Wherry, MSc, MS, Head of Data Systems, R&D Quality, Global Quality, Takeda Pharmaceutical Company Limited

Mark Yunger, Director IT, Servier Pharma

Joseph Zec, Associate Director, CSV and Compliance, Takeda

Distinguished Speaking Faculty:

Join Us to Discuss Critical Content:CSV • Cybersecurity • Audit Trails • Supplier Management • Pharma 4.0 • Non-Product Validation

Integrated Compliance • Computer Software Assurance • Cloud Implementation • Paperless Validation Risk Mitigation • Software Testing • SaaS Solutions • Data Privacy

4

AGENDA-AT-A-GLANCED AY O N E W E D N E S D AY, A P R I L 2 9 , 2 0 2 0

7:30 Conference Registration and Continental Breakfast

8:30 Co-Chair’s Welcome and Opening Remarks

8:45 Keynote Address • Cybersecurity and Compliance — The Future of Validation in GxP Systems

9:30 Fireside Conversation • Update on FDA and Industry Collaboration on Computer Software Assurance (CSA)

10:30 Networking and Refreshment Break

11:00 Moving Towards Pharma 4.0 — Training and Testing of Machine Learning Models

12:00 Networking Luncheon

1:00 CHOOSE FROM 2 CONCURRENT TRACKS (A-B)

A. Cloud Computing and Data Integrity Validation Track B. Quality Assurance/Quality by Design Track

1:00 Ensuring e-Records Integrity in the Cloud Environment 1:00 Case Study • Merck’s Digital SDLC — Journey to Paperless SDLC/CSV

2:00 To Audit or Not to Audit — Risk-Based Approaches for Cloud Vendor Management

2:00 Emerging Trends in Oversight and Enforcement — A Review of 483s and Warning Letters


3:30 CHOOSE FROM 2 CONCURRENT TRACKS (A-B)

A. Cloud Computing and Data Integrity Validation Track B. Quality Assurance/Quality by Design Track

3:30 Panel • Managing Change Control for Cloud Implementation 3:30 Computer Validation Audits — The Good, The Bad and The Ugly

4:30 Mitigate Risk for Selection, Implementation and Management of SaaS Solutions 4:30 Security by Design — Designing With Compliance in Mind

5:30 Close of Day One • Networking, Wine and Cheese Reception Following Last Session

D AY T W O T H U R S D AY, A P R I L 3 0 , 2 0 2 07:30 Continental Breakfast

8:15 Co-Chair’s Review of Day One

8:30 Integrated Compliance — The Intersection of QA and IT

9:15 SDLC Modernization — Continuous Quality with eSignatures for DevOps Tools in an FDA-Regulated Environment


10:30 Software Testing Strategies for Computerized Systems Validation

11:30 Expectations vs. Reality — Investing Resources into the Appropriate Risks for Validation


1:15 Spotlight Session • Audit Trail Reviews for Data Integrity — Risk Mitigation and the Audit Trail Checklist


3:45 Bring Your Own CSV Challenge

5:15 Close of Day Two • Networking, Wine and Cheese Reception Commences

D AY T H R E E F R I D AY, M AY 1 , 2 0 2 08:00 Continental Breakfast

8:45 Co-Chair’s Review of Day Two

9:00 CHOOSE FROM TWO 90-MINUTE BREAKOUTS (1-2)

1. Enhancing Cybersecurity and Data Privacy in Validated Systems Environments

2. Best Practices for Supplier Management and Vendor Auditing


11:00 CHOOSE FROM TWO 1-HOUR BREAKOUTS (3-4)

3. Validation of SaaS Systems 4. Strategic Approaches to Utilization of Automated Validation Tools


1:00 CHOOSE FROM TWO 1-HOUR BREAKOUTS (5-6)

5. Best Practices for Non-Product Software Validation 6. New Approaches to Old Tasks — Methods for Implementing Paperless Validation

2:00 Live Polling Benchmarking Discussion

2:45 Close of Conference

5

7:30 Conference Registration and Continental Breakfast

8:30 Co-Chair’s Welcome and Opening RemarksKen Shitamoto, Senior Director, IT, Gilead

Senthil Gurumoorthi, Associate Director, Gilead

8:45 KEYNOTE ADDRESS Cybersecurity and Compliance — The Future of Validation in GxP Systems • Discuss the role of cybersecurity in compliance and the growing

alignment between teams• Assess how the long-term outcomes of validation rely on

cybersecurity decision-making and maturity• Break down dos and don’ts relating to the future of cybersecurity

and complianceNathan McBride, Vice President, Information Technology, Ohana Biosciences, Inc.

9:30 FIRESIDE CONVERSATION Update on FDA and Industry Collaboration on Computer Software Assurance (CSA) Hear directly from members of the FDA/industry collaborative team on the scope of what the new draft guidance, “Computer Software Assurance for Manufacturing, Operations and Quality System Software” may entail.• Discuss industry recommendations for anticipated FDA

draft guidance • Hear success stories of implementing the guidance and

the resulting benefits

• Analyze the challenges and solutions to automating non-product CSV

Ken Shitamoto, Senior Director, IT, Gilead

Harsha Chulki, Head of Global IT Quality & CSV, ICU Medical


11:00 Moving Towards Pharma 4.0 — Training and Testing of Machine Learning Models• Outline key challenges for AI models in healthcare and the

impact on decision-making• Discuss how the lack of robust training data affects the accuracy

of the models• Review options for completing accurate model testing and

training without compromising data• Establish a methodology to help de-identify such models using

deep learning• Gain an understanding of applicable controls, along with testing

approaches and guidelinesAnu Virkar, PMP, Head of Quality and Compliance Watson Health LS, IBM


DAY ONE WEDNESDAY APRIL 29, 2020

1:00 C H O O S E F R O M 2 CO N C U R R E N T T R AC KS ( A- B )

A. Cloud Computing and Data Integrity Validation TrackTrack Chair: Mark Yunger, Director IT, Servier Pharma

1:00 Ensuring e-Records Integrity in the Cloud Environment• Examine how e-records integrity impacts cloud computing• Assess the use of cloud computing from the perspective of

security and e-records integrity• Evaluate the risks of cloud computing in the GxP environment• Identify the e-records integrity controls in the cloud

computing environment• Learn how to prevent and detect e-records integrity issues

Orlando Lopez, E-compliance and E-records SME

2:00 To Audit or Not to Audit — Risk-Based Approaches for Cloud Vendor Management • Review the evolving cloud environment, including types of

vendor options and market trends• Identify goals and responsibilities for vendor management• Establish processes for vendor risk assessment and

management• Navigate application changes and security/patch updates on

controlled cloud environments• Assess risks of poorly defined governance and policies• Walk through a vendor/supplier assessment

Robert Wherry, MSc, MS, Head of Data Systems, R&D Quality, Global Quality, Takeda Pharmaceutical Company Limited

1:00 CASE STUDY Merck’s Digital SDLC — Journey to Paperless SDLC/CSV• Background• Vision — Moving from a fractured to seamless environment• The Journey — Crawl, walk, run• Features of the platform• Compliance, agility and competitive advantage are compatible

Daniel Dziadiw, Director, IT Compliance & Risk Management-GRC Platform Leader, Merck

2:00 Emerging Trends in Oversight and Enforcement — A Review of 483s and Warning Letters with Focus on Global CSV Enforcement, Data Integrity in Production and Laboratory Systems • Review recent domestic and international FDA 483 and

warning letters • Evaluate emerging global trends in computer systems

validation and data integrity• Discuss trends in computerized systems validation

production equipment, laboratory (R&D, QC and Micro) systems and technology

• Tackle lingering issues with an open question and answer (and potentially solve your problems on the spot!)

Gaurav Walia, Principal Consultant in Computerized System Validation/Compliance, Data Integrity and Processes Qualification, PQE


B. Quality Assurance/Quality by Design TrackTrack Chair: Luke Black, Validation & Quality Manager, Pharma Supply Chain – Global Computer Validation (PSC GCV), GSK

“ Extremely organized and informative sessions. Each speaker encouraged questions and an open discussion. Highly recommend!”

— IT Project Manager, Rhodes Pharmaceuticals

6

3:30 C H O O S E F R O M 2 CO N C U R R E N T T R AC KS ( A- B )

A. Cloud Computing and Data Integrity Validation TrackTrack Chair: Mark Yunger, Director IT, Servier Pharma

B. Quality Assurance/Quality by Design TrackTrack Chair: Luke Black, Validation & Quality Manager, Pharma Supply Chain – Global Computer Validation (PSC GCV), GSK

3:30 PANEL DISCUSSION Managing Change Control for Cloud Implementation• Discuss the need for change control and challenges of

the process• Establish the differences between change classification

and assessments• Review case examples and challenges

PANELISTS: Bhaskar Aryasomayajula, Senior Manager, Computer Systems Validation, Mallinckrodt


Cynthia Pleach, Manager, Quality Assurance IT, Sage Therapeutics

4:30 Mitigate Risk for Selection, Implementation and Management of SaaS Solutions • Vendor assessment — Assessment before contract

* intrusion detection* data center security* validation process* off-shore resources* API development/testing* internal training* 21 CFR Part 11 compliance

• Implementation* validation shared responsibility model* roles and responsibilities

• Post-Implementation* releases, upgrades, patches, integrations* change management* outage and breach notification

Holly A. Baldwin, Validation Specialist, HireGenics

5:30 Close of Day One

Networking, Wine and Cheese Reception Immediately Following the Close of Day One

3:30 Computer Validation Audits — The Good, The Bad and The Ugly• Introduction

* how to prepare for a good CSV audit while limiting the bad and ugly aspects

* how are inspector and inspected audits (internal and external) similar yet different?

• Inspector Audits — Documentation* which approved policies, SOPs and templates should govern

CSV audits?* how should CSV audit documentation be stored and maintained?

• Inspector Audits — Planning an audit* what triggers a CSV audit?* how to determine who are the key audit contact(s)* how to announce the audit scope, agenda and dates* how to determine which minimum CSV material will be requested

• Inspector Audits — Conduct an audit* how to facilitate a kickoff meeting* when reviewing requested material, what should be reviewed

against which criteria?* how to log observations, findings and other relevant notes* how to conduct the closeout meeting* how to issue the audit report with a response deadline* when an audit response is received, what should be reviewed?

• Inspected Audits — Be prepared* how to implement internal procedures for management of an

unanticipated CSV audit* how to respond to audit reports with finding remediation plans

BONUS MATERIAL Sample MS-Word CSV Audit Templates

Leslie Lighton-Humphries, IT SQA & CSV Manager, AmerisourceBergen

4:30 Security by Design — Designing With Compliance in Mind Security by Design in pharmaceuticals presents some unique challenges to security professionals and internal IT teams. The improvement in technology and expected lifecycle of applications are at direct odds with the data retention rules and demand for availability of systems. • Introduction to Security by Design, its requirements and foundations• Steps to better data security• Elements of a good data security program • Event analysis• Challenges in implementing Security by Design• Forensics to find out actual data manipulation

Deepak Saini, Director IT, Dr. Reddy’s Laboratories

7:30 Continental Breakfast

8:15 Co-Chair’s Review of Day OneKen Shitamoto, Senior Director, IT, Gilead

Senthil Gurumoorthi, Associate Director, Gilead

8:30 Integrated Compliance — The Intersection of QA and IT• Assess the overlap between regulations and agencies on

a global scale• Discern applicable regulations to define and demonstrate

compliance in a single pass• Develop testing and policies that satisfy all regulators and

achieve significant efficiency in the process• Outline the basics for starting an integrated compliance program• Discuss challenges, opportunities and benefits that can be

realized with integrated compliance

Harsha Chulki, Head of Global IT Quality & CSV, ICU Medical


9:15 SDLC Modernization — Continuous Quality with eSignatures for DevOps Tools in an FDA-Regulated Environment• Strategy and roadmap• Quality and compliance management platform for data control,

review/approval and eSignatures

Raechelle Raimondo, Executive Director, Global IT Quality, AllerganJason Tepfenhardt, Managing Partner and Co-Founder, Tx3


10:30 Software Testing Strategies for Computerized Systems Validation• Main testing paradigms in software validation

* waterfall * agile

• Risk-based testing* testing vs. GAMP categories* testing vs. USP 1058 groups, for computerized lab instruments

• IQ/OQ/PQ vs. system testing/user acceptance testing* when to use one or the other

• Fundamentals of software testing — What these are and how to use them* before validation — development testing, FAT, SAT,

“smoke” testing* installation qualification/verification* positive vs. negative testing* boundary testing* interface testing* business process end-to-end testing* stress testing

* performance testing* data migration and conversion testing

• Compliance and practical aspects* GDP* training * requirements coverage* bracketing and logical paths coverage* using testing software

• How not to test the wrong thingRaul Soto, Senior Principal Software Engineer, Johnson & Johnson VisionCare

11:30 Expectations vs. Reality — Investing Resources into the Appropriate Risks for Validation• Considerations for an enterprise deployment • Acceptance and implementation of a “core model” • Practical strategies for DI compliance

Brian DiVasta, Associate Director, ITS Compliance, Sanofi


1:15 SPOTLIGHT SESSION Audit Trail Reviews for Data Integrity — Risk Mitigation and the Audit Trail Checklist• Outline strategies required to generate compliant audit trails• Learn how to use a risk-based approach to review audit trails• Evaluate the need for ongoing reviews based on system criticality

and complexity• Activity

Eileen Cortes, EIT, MBA, Director, QA Global Validation, BioMarin (invited)




3:45 Bring Your Own CSV ChallengeIn recent years, validation and data integrity have been hot button issues for regulators. With new guidelines anticipated and numbers of citations increasing, industry must take a critical look at their current processes and the key areas for improvement. During this interactive session, attendees are encouraged to submit CSV challenges, highlight real issues they face on a regular basis and ask peers the questions that remain unanswered. Together, we will discuss these challenges, review effective strategies and propose solutions that will hopefully help in the vital effort of optimizing CSV and data integrity.

Joseph Zec, Associate Director, CSV and Compliance, TakedaPat Hebert, Head of Quality – Digital/Data Compliance, Biologics, Sanofi

DAY TWO THURSDAY APRIL 30, 2020

5:15 Close of Day Two

Networking, Wine and Cheese Reception Immediately Following the Close of Day Two

DAY THREE FRIDAY MAY 1, 20208:00 Continental Breakfast

8:45 Co-Chair’s Review of Day TwoKen Shitamoto, Senior Director, IT, Gilead Senthil Gurumoorthi, Associate Director, Gilead

9:00 C H O O S E F R O M T WO 9 0 - M I N U T E B R E A KO U TS ( 1 - 2 )

1 PANEL DISCUSSION Enhancing Cybersecurity and Data Privacy in Validated Systems EnvironmentsCybersecurity is an increasingly relevant concern for industry that poses a variety of new challenges and risks. During this interactive panel discussion, key issues and strategies will be outlined, including:• Roles and departments responsible for managing cybersecurity • Risks associated with outdated processes and effective strategies

for risk mitigation• How and why to conduct cybersecurity qualifications in addition

to standard testing • Importance of developing a security culture to empower proactive

cybersecurity and awarenessPANELISTS: Sandra Liu, Head of IT Validation, Compliance and Assurance (Director), Jazz Pharmaceuticals Mark Yunger, Director IT, Servier Pharma Deepak Saini, Director IT, Dr. Reddy’s Laboratories

2 PANEL DISCUSSION Best Practices for Supplier Management and Vendor AuditingDiscuss critical steps to ensure suppliers are compliant with GMP standards and outline strategies for comprehensive checklists, including the following assessments:• Risk-based determination of how frequently a supplier needs

to be audited based on type, geography, familiarity, etc. • Decision of what to audit for each vendor — Process, system, procedure • Evaluation of SOPs, personnel and failure investigation processes• Design, development and testing methodologies• Code change control and version control practicesPANELISTS: Anu Virkar, PMP, Head of Quality and Compliance Watson Health LS, IBMGaurav Walia, Principal Consultant in Computerized System Validation/Compliance, Data Integrity and Processes Qualification, PQERaul Soto, Senior Principal Software Engineer, Johnson & Johnson VisionCare


11:00 C H O O S E F R O M T WO 1 - H O U R B R E A KO U TS ( 3 - 4 )

3 Validation of SaaS SystemsSoftware as a Service (SaaS) is quickly becoming the method of choice for gathering, storing and managing regulated data. There are many benefits to utilizing SaaS; however, SaaS systems provide their own unique challenges, especially in a regulated environment. This presentation will showcase and review the unique challenges faced by emerging technologies in this domain. The goal to facilitate compliance through utilization of impact analysis, documentation and automated testing.• Understand impact of SaaS on a regulated environment

* outline benefits, including lack of required infrastructure, ease of deployment into an environment and decrease in maintenance costs

* discuss challenges including variable, unexpected and uncontrollable system updates

• Review strategies for implementing SaaS* dive into case studies on real world situations* evaluate potential solutions or tools for your toolbox, including

various techniques used by both SaaS providers and customers• Assess strategies for working with SaaS vendors

* methods to ensure that ‘for use’ testing is completed by software providers and meets internal quality and regulatory requirements

Anu Virkar, PMP, Head of Quality and Compliance Watson Health LS, IBM

4 Strategic Approaches to Utilization of Automated Validation ToolsOperational efficiency is a critical business priority that is made challenging in an ever-evolving regulatory landscape. Despite the productivity and quality opportunities of automated testing techniques in computer validation, adoption has been slow in the life sciences industry.• Outline key benefits of automated computer system validation• Identify which components of an automated validation solution

are most important for determining viability• Consider how automated solutions can account for upgrades


1:00 C H O O S E F R O M T WO 1 - H O U R B R E A KO U TS ( 5 - 6 )

5 ROUNDTABLE DISCUSSIONS Best Practices for Non-Product Software Validation • Discuss rigor around product risk in relation to non-product

software and critical elements for risk analysis• Evaluate security requirements specific to medical devices • Enhance understanding of evolving regulations that must be met • Review tools and mechanisms to get to market in a faster, more

compliant manner • Assess current initiatives between industry and regulators to

streamline validationMODERATOR: Frankie Bill, IT Manager – QA Governance, Medtronic

6 New Approaches to Old Tasks — Methods for Implementing Paperless Validation • Understand benefits of paperless solutions• Assess challenges in the journey towards paperless• Discuss opportunities for hybrid implementation• Review how to evaluate and select a solution• Identify critical functionalities and opportunities for building

in flexibilityBhaskar Aryasomayajula, Senior Manager, Computer Systems Validation, Mallinckrodt

2:45 Close of Conference

2:00 Live Polling Benchmarking DiscussionDuring this session, the benchmarking data provided by live polling serves as the basis for discussion and information exchange. Participants will gain industry best practices for managing effective and compliant validation programs. This is an excellent opportunity to understand industry trends and discuss with peers.

Ken Shitamoto, Senior Director, IT, Gilead Senthil Gurumoorthi, Associate Director, Gilead

Top Titles Validation Engineering Quality

Top Titles

Top Titles

Top Titles

AUGUST 2020

PHILADELPHIA, PA

Recalls Quality Regulatory

Validation Quality Engineering

SEPTEMBER 2020 • WASHINGTON, DC

SEPTEMBER 2020 • SAN DIEGO, CA

OCTOBER 2020 • SAN DIEGO, CA

Pharmacist/ Pharmacy Ops

Quality/ Compliance C-Level

Lab and CleaningValidation Week

Life Sciences

SEPTEMBER 17-18, 2019 • SHERATON SILVER SPRING HOTEL • SILVER SPRING, MD

Recent Enforcement Updates • Risk-Based Decision Making • Navigation of Global Requirements

RECALLS, RETURNS& REMOVALS SUMMIT

Compounding Pharmacy Compliance WEST

Navigate the Changing Regulatory Landscape and Enhance Quality Programs

�� • �� • ��

ALIDATION WEEK26TH ANNUAL

Top Titles Automation Engineering Manufacturing

Top Titles

Top Titles

Top Titles Compounding Pharmacy Compliance ��• ��

��

FEBRUARY 5-6, 2020 • PHILADELPHIA, PA

IT/Systems Validation Quality

Validation Quality Engineering

Pharmacist/ Pharmacy Ops

Quality/ Compliance C-Level

21ST ANNUAL


ITand Computerized Systems Validation WeekRobust Knowledge Exchange Addressingthe Complexities of System Integration,Computer Validation and FDA ReadinessAPRIL 29 - MAY 1, 2020 • PHILADELPHIA, PA

21ST ANNUAL



11TH ANNUAL

MAY 2020 • DUBLIN, IRELAND

JUNE 18-19, 2020 ARLINGTON, VA

QUALITY & VALIDATION CONFERENCE PORTFOLIO

2020 EVENT LINEUP

VALIDATION AND LAB WEEK EUROPE

10

“As a first time attendee of an IVT event… I was satisfied with the material presented and the information disseminated/acquired. Great forum to network and learn. Would not hesitate to attend in the future.”

“I was impressed with the quality of the presenters, very knowledgeable

and so down to earth, that by sharing their experiences make you feel, ‘you’re not alone.’

You will learn a lot!”

“Really great conference with a lot of helpful

content to refine our validation program.”

“I really enjoyed the presentations and getting updated with what is happening in the industry.”

JUST SOME OF THE PARTICIPATING COMPANIES OVER THE YEARS:

Abbott Laboratories • Accuray • Alkermes • Allergan • Alnylam • AMAG Pharmaceutical • Amneal Pharmaceuticals • Apotex • Arthrex • AstraZeneca • Bayer US • BioMarin • Boehringer Ingelheim • Celgene • Clovis Oncology • Cook Myosite • Dexcom • Dynavax • Edwards LifeSciences • Fujirebio

Diagnostics • Gilead Sciences • Gossamer Bio • Grifols Therapeutics • GW Pharmaceuticals • Hikma • ICU Medical • Illumina • ImmunoGen • Ionis Pharmaceuticals • Jazz Pharmaceuticals • Johnson &

Johnson • Juno Therapeutics • Kedrion Biopharma • Kite Pharma • La Jolla Pharmaceutical Company • Lantheus Medical Imaging • Lilly • Merck • MyoKardia • Myriad Genetics • Nevro Corp • Novo Nordisk • Ortho Molecular Products • Partner Therapeutics • PaxVax • Pfizer • Pharmascience • PTC Therapeutics • Quidel • Regeneron • REGENXBIO Inc • Roche Diabetes Care Inc • Sage Therapeutics • Sanofi • Shire • Smith & Nephew • Takeda Pharmaceuticals • TherapeuticsMD • Thermo Fisher Scientific • Ultragenyx •

Vericel Corporation • WL Gore & Associates

PREVIOUS ATTENDEE ACCLAIM:

11

REGISTR ATIONREGISTRATION FEE:

Advantage Rate Register by 2/7/20

Standard Rate Register by 4/28/20

Onsite Rate

Life Sciences Manufacturers $2399 $2699 $2799

Solution Providers/ Consultants $2799 $3099 $3199

Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Credit Card (Visa, MC, AMEX, Discover) or checks accepted. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.)

PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate.

WEDNESDAY, APRIL 29, 2020

1:00–3:00 A B

3:30–5:30 A B

FRIDAY, MAY 1 , 2020

9:00–10:30 1 2

11:00–12:00 3 4

1:00–2:00 5 6

CHOOSE BREAKOUT SESSIONS:

W W W . C B I N E T . C O M / C S V

PI20045

VENUE

Hilton at Penn’s Landing201 S. Christopher Columbus BoulevardPhiladelphia, PA 19106Hotel Direct Line: +1 (215) 521 6500

SUBSTITUTION & CANCELLATION

Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. All cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $499 administrative charge. No refunds will be made after this date; however, the registration fee less the $499 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the conference registration fee only. Cancellation of a conference due to events beyond our control* are subject to a $499 administrative charge should you or a colleague be unable to attend the rescheduled date. CBI reserves the right to alter this program without prior notice. Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or CBI.

*Events beyond our control include: severe weather conditions, natural and man-made

disasters and any other similar events.

ACCOMMODATIONS

To receive CBI’s discounted hotel rate, visit: cbinet.com/csv

Book Now! For hotel room availability and direct booking links, please visit www.cbinet.com/csv and select the Venue-Pricing tab. Rooms are limited so please book early. All travel arrangements are subject to availability.

GROUP RATELooking to bring your team? Contact Information Services to learn about potential group savings. Call 339-298-2158 or email [email protected].

* Advantage pricing rates do apply when applicable. Offer may not be combined with

any other special pricing promotions. Offer may be used at IVT/CBI

co-located events.

SATISFACTION GUARANTEED

IVT stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable CBI /IVT conference of your choice. Please contact 800-817-8601 for further information. Advanced preparation for IVT conferences is not required.

3 EASY WAYS TO REGISTERWEBSITE: www.cbinet.com/csvPHONE: 800.817.8601EMAIL: [email protected]

LET'S GET SOCIAL... follow us on

YouTube

IVT Network

follow us on Twitter

@IVT_Network

follow us on Facebook

IVT Network IVT Network

follow us on LinkedIn

12

12


CBI 70 Blanchard Road Burlington, MA 01803

R E G I S T E R AT W W W.C B I N E T.C O M /C S V • 8 0 0 - 8 1 7 - 8 6 0 1

REGISTER BY FEBRUARY 7, 2020 AND SAVE $300!

21ST ANNUAL



RE

GIS

TE

R B

Y F

EB

RU

AR

Y 7

, 20

20

TO

SA

VE

$3

00

!

ANY QUESTIONS OR TO REGISTER CONTACT:

Stuart Steller phone 339-298-2158 email [email protected]

21st A

nn

ua

l

IT and C

omp

uterized

Systems Va

lida

tion Week

Robust Knowledge Exchange Addressing

the Complexities of System

Integration, Com

puter Validation and FDA ReadinessA

PRIL 2

9 – M

AY

1, 2

02

0 H

ILTON

AT PEN

N’S LA

ND

ING

PH

ILAD

ELPHIA

, PA 21

ST A

NN

UA

L

APR

IL 29 – MA

Y 1, 2020 •

HILTO

N A

T PENN

’S LAN

DIN

G •

PHILA

DELPH

IA, PA

ITand

Com

puterized System

s Validation Week

Rob

ust K

no

wle

dg

e Exc

ha

ng

e A

dd

ressin

gth

e C

om

plexitie

s of Syste

m In

teg

ratio

n,

Co

mp

ute

r Valid

atio

n a

nd

FDA

Rea

din

ess

A. Cloud Computing and Data Integrity Validation

B. Quality Assurance/Quality by Design

CU

ST

OM

IZE

YO

UR

EX

PE

RIE

NC

E A

ND

SE

LE

CT

AM

ON

G T

WO

TR

AC

KS

MED

IA PA

RTN

ERS:

RE

GIS

TE

R A

T W

WW

.CB

INE

T.C

OM

/C

SV

• 8

00

-817

-86

01

FE

AT

UR

ING

LEA

DIN

G IN

DU

STR

Y P

ER

SP

EC

TIV

ES

FR

OM

:A

llergan • D

r. Red

dy’s Lab

orato

ries • Gilead

• Glaxo

Sm

ithKline • IC

U M

edical

Jazz Pharm

aceuticals • Johnso

n & Jo

hnson V

isionC

are • Mallinckro

dt • M

edtro

nic M

erck • Orchard

Therap

eutics • Sag

e Therap

eutics • Sano

fi • S

ervier Pharm

a • Takeda

KE

YN

OT

E

Cybersecurity and Com

pliance —

The Future of Validation in GxP System

s

CR

ITIC

AL

UP

DA

TE

Moving Tow

ards Pharm

a 4.0

SP

OT

LIG

HT

S

ES

SIO

N

Audit Trail Reviews

for Data Integrity —

Risk Mitigation and the

Audit Trail Checklist

FIR

ES

IDE

C

ON

VE

RS

AT

ION

FDA/Industry Collaboration on

Computer Softw

are Assurance (CSA)

A division of

UB

M A

mericas

Brought to you by Inform

a Connect


IT and Computerized Systems Validation Week

Documents

Transcript of IT and Computerized Systems Validation Week