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Life Sciences Cloud & Infrastructure Conference

April 5, 2018  |  Silver Spring, Maryland

Please join ISPE Chesapeake Bay Area Chapter,  Maryland Tech Council & BioHealth Innovation at ByteGrid’s Flagship Data Center ‘MDC1’ for a one day Life Science Cloud & Infrastructure Conference:

  • Hear from the co-chairs of the GAMP Cloud Special Interest Group
  • Understand the updates to the new and revised ISPE GAMP Good Practice Guide on IT Infrastructure from ByteGrid’s Stephen Ferrell who led the update
  • Get insights into cloud adoption in the regulated Life Sciences
  • Gain an understanding of the common cloud and infrastructure certifications SOC 2, PCI, ISO27001 etc. and how they can supplement traditional GxP controls and qualification strategies
  • Take part in a tour of the largest data center in Maryland and one of the few qualified and managed under GxP controls

 

Event Registration

ISPE or Tech Council of Maryland Members: $20
Non-Members: $25

Space is limited, register early.

REGISTER NOW

Sponsors

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Agenda

8-8:30 – Registration

8:30 – 9:00 – Breakfast

9:00-9:15 – Opening Remarks (Judy Samardelis - Director, IT Quality and Compliance at AstraZeneca Pharmaceuticals)

9:15 – 10:00 - Infrastructure Good Practice Guide – Key Difference with Version 2 (Stephen Ferrell - Vice President, Product Strategy at ByteGrid)

10:00 – 10:45 – Current Infrastructure Audit Trends (Doug Shaw - Director of IT & CSV Consulting at Azzur Group)

10:45 – 11:00 – Break

11:00- 11:45 – Cloud & Data Integrity (Krishna Ghosh, Ph. D. - Senior Policy Advisor at the Food and Drug Administration)

11:45- 12:30 - Lunch

12:30 – 1:15 – Interactive tour (Group A) | SOC, ISO27001, PCI, & HITRUST in the GxP Context (Group B) (Rebecca Santorios - Vice President, Governance, Risk & Compliance at ByteGrid)

1:15 – 2:00 - Interactive tour (Group B) | SOC, ISO27001, PCI, & HITRUST in the GxP Context (Group A) (Rebecca Santorios - Vice President, Governance, Risk & Compliance at ByteGrid)

2:00 – 2:15 – Break

2:15 – 3:00 – Compliance in the Cloud – Practical Experience from the Life Science Industry (Marie Gustafsson - Principal Consultant at Epista Life Science)

3:00 – 3:45 – Workshop: Quality Agreements with Cloud Providers (James Rogers - Chief Executive Officer at Compass Life Science Solutions)

3:45 – 4:30 – Industry 4.0: Implications for Life Sciences (Jaleel Shujath - Director, Life Sciences Strategy at OpenText)

4:30 – 4:45 – Closing Remarks

4:45 – 5:30 – Cocktails and Hors d’oeuvres

Speakers

Stephen Ferrell
Vice President, Product Strategy at ByteGrid

Krishna Ghosh, Ph. D.
Senior Policy Advisor at the Food and Drug Administration

Marie Gustafsson
Principal Consultant at Epista Life Science

James Rogers
Chief Executive Officer at Compass Life Science Solutions

Doug Shaw
Director of IT & CSV Consulting at Azzur Group

Judy Samardelis
Director, IT Quality and Compliance at AstraZeneca Pharmaceuticals

Rebecca Santorios
Vice President, Governance, Risk & Compliance at ByteGrid

Jaleel Shujath
Director, Life Sciences Strategy at OpenText

 

Location

Conference Venue:

ByteGrid
12401 Prosperity Drive
Silver Spring, MD 20904

 

Accomodations:

Courtyard Silver Spring North
12521 Prosperity Drive
Silver Spring, MD 20904
Book Online or call 1(800) 321-2211 and mention "ByteGrid" for $159 group rate. Group rate expires 3/16/18.

Hilton Garden Inn Silver Spring North
2200 Broadbirch Drive
Silver Spring, MD 20904
(301) 622-3333

REGISTER NOW