IT and Computerized Systems Validation Week
Transcript of 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
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24%21%
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8%
Optimize Opportunities for Connecting and Benchmarking
Conference Sponsor:
A division ofUBM Americas
Brought to you by Informa Connect
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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
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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
3:00 Networking and Refreshment Break
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
10:00 Networking and Refreshment Break
10:30 Software Testing Strategies for Computerized Systems Validation
11:30 Expectations vs. Reality — Investing Resources into the Appropriate Risks for Validation
12:15 Networking Luncheon
1:15 Spotlight Session • Audit Trail Reviews for Data Integrity — Risk Mitigation and the Audit Trail Checklist
3:15 Networking and Refreshment Break
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
10:30 Networking and Refreshment Break
11:00 CHOOSE FROM TWO 1-HOUR BREAKOUTS (3-4)
3. Validation of SaaS Systems 4. Strategic Approaches to Utilization of Automated Validation Tools
12:00 Networking Luncheon
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
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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
10:30 Networking and Refreshment Break
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
12:00 Networking Luncheon
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
3:00 Networking and Refreshment Break
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
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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
Joanne Goldberg, Senior Principal IT Business Systems Analyst, Medtronic
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
Pat Hebert, Head of Quality – Digital/Data Compliance, Biologics, Sanofi
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
10:00 Networking and Refreshment Break
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
12:15 Networking Luncheon
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)
Joanne Goldberg, Senior Principal IT Business Systems Analyst, Medtronic
Pat Hebert, Head of Quality – Digital/Data Compliance, Biologics, Sanofi
3:15 Networking and Refreshment Break
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
10:30 Networking and Refreshment Break
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
12:00 Networking Luncheon
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
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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
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ALIDATION WEEK26TH ANNUAL
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FEBRUARY 5-6, 2020 • PHILADELPHIA, PA
IT/Systems Validation Quality
Validation Quality Engineering
Pharmacist/ Pharmacy Ops
Quality/ Compliance C-Level
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 ReadinessAPRIL 29 - MAY 1, 2020 • 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
11TH ANNUAL
MAY 2020 • DUBLIN, IRELAND
JUNE 18-19, 2020 ARLINGTON, VA
QUALITY & VALIDATION CONFERENCE PORTFOLIO
2020 EVENT LINEUP
VALIDATION AND LAB WEEK EUROPE
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“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:
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REGISTR ATIONREGISTRATION FEE:
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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
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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
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A division ofUBM Americas
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
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
RE
GIS
TE
R B
Y F
EB
RU
AR
Y 7
, 20
20
TO
SA
VE
$3
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!
ANY QUESTIONS OR TO REGISTER CONTACT:
Stuart Steller phone 339-298-2158 email [email protected]
21st A
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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
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, PA 21
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APR
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HILTO
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T PENN
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PHILA
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IA, PA
ITand
Com
puterized System
s Validation Week
Rob
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ha
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e A
dd
ressin
gth
e C
om
plexitie
s of Syste
m In
teg
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Co
mp
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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
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EX
PE
RIE
NC
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ND
SE
LE
CT
AM
ON
G T
WO
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MED
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RTN
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RE
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T W
WW
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T.C
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/C
SV
• 8
00
-817
-86
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FE
AT
UR
ING
LEA
DIN
G IN
DU
STR
Y P
ER
SP
EC
TIV
ES
FR
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: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)
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