PLAY RECORDING

Broadcast Date: Thursday, September 22, 2022
from 12:00 pm to 1:30 pm (ET)

CLE/CPE credit will not be awarded in this course.

Overview:

Early-stage life sciences organizations face many challenges, but planning and implementing IT doesn’t have to be one of them. Discover powerful tools and techniques to help you set priorities and make decisions with confidence. Follow key principles and techniques to ensure you make the right investments at the right time with partners that are the best possible fit for your organization. Learn how to build a strategic IT roadmap, define roles and responsibilities, and establish processes to make successful software investments.

A right-sized regulatory compliance program lets you implement your GxP or SOX applications efficiently, mitigate risks to patient safety and product quality, and prepare for inspections. Achieve greater cyber maturity with privacy frameworks and safeguard privacy as your business grows in size, value, complexity, and capabilities.

This webinar will help you to rethink your challenges and develop an IT strategy from the pre-clinical phases through commercialization.

We will discuss:

  • Building a strategic IT roadmap that includes critical regulatory and functional requirements and milestones
  • Understanding business needs and drivers for G&A and GxP functional areas
  • Making timely and scalable IT investments
  • Establishing or harmonizing an IT compliance program to fuel growth
  • Addressing cybersecurity and privacy needs
  • Resourcing models—such as fractional CIOs, managed services, and staff augmentation—to efficiently achieve business objectives
  • Case studies for rapid growth and transformation

Credit:

Course Level:

Intermediate

 

Advance Preparation:

Print and review course materials

 

Method of Presentation:

On-Demand Webcast

 

Prerequisite:

General knowledge of IT roadmaps

 

Course Code:

1410511

 

NY Category of CLE Credit:

Areas of Professional Practice

 

Total Credit:

1.5 CLE

Speaker Panel:

Erin Northington, VP of Emerging Life Sciences and Clinical Solutions
20+ Years of Life Science Experience with a Focus on Pre-commercial Companies

USDM Life Sciences

Erin focuses on helping start-up biotech, pharma, and medical device companies accelerate their commercialization journey and establish their IT and regulatory compliance strategies. She has over two decades of experience in life sciences GxP applications, business relationship management, regulatory compliance program management, and IT strategy development. Before USDM, Erin worked in various IT roles overseeing global technology teams and has extensive expertise in enterprise-wide process improvement.

Roger Davy, Director of Emerging Customer Engagement
20+ Years Industry Role in Pharma

USDM Life Sciences

Roger has over 20 years of experience in consulting and industry roles in the pharma, biotech, engineering, and semiconductor industries. Working with small and large life sciences firms, Roger leads professional services teams to deliver transformative compliance, technology, and cybersecurity programs. Roger helps his emerging life sciences clients by implementing cloud-based enterprise IT solutions, supporting successful regulatory submissions and inspections, and managing post-acquisition integration programs.

Hovsep Kirikian, Director of Product Management
15+ Years Experience Managing Projects

USDM Life Sciences

Hovsep leads USDM’s Veeva practice and has over 15 years of experience managing projects in the life sciences industry, specifically focusing on regulatory compliance, validation, equipment lifecycle, laboratory operations, and data and content management across all phases of the product life cycle.

Agenda:

Erin Northington, VP of Emerging Life Sciences and Clinical Solutions

USDM Life Sciences

AND

Roger Davy, Director of Emerging Customer Engagement

USDM Life Sciences

AND

Hovsep KirikianDirector of Product Management

USDM Life Sciences

  • Building a strategic IT roadmap that includes critical regulatory and functional requirements and milestones
  • Understanding business needs and drivers for G&A and GxP functional areas
  • Making timely and scalable IT investments
  • Establishing or harmonizing an IT compliance program to fuel growth
  • Addressing cybersecurity and privacy needs
  • Resourcing models—such as fractional CIOs, managed services, and staff augmentation—to efficiently achieve business objectives
  • Case studies for rapid growth and transformation

Date & Time:

Thursday, September 22, 2022

12:00 pm to 1:30 pm (ET)

Materials:

Download Course Materials

Who Should Attend:

  • Chief Quality Officers
  • Chief Risk Officers
  • Chief Compliance Officers
  • Chief Operating Officers
  • Chief Information Officers
  • Chief Technology Officers
  • Chief Financial Officers
  • Chief Supply Chain Officers
  • Chief Procurement Officers
  • VPs/Directors of Compliance
  • VPs/Directors of Operations
  • VPs/Directors of IT
  • VPs/Directors of Risk
  • VPs/Directors of Quality
  • Quality Assurance VPs/Directors

SPONSOR

SPEAKERS

Erin NorthingtonVP of Emerging Life Sciences and Clinical Solutions
20+ Years of Life Science Experience with a Focus on Pre-commercial Companies
USDM Life Sciences
Roger DavyDirector of Emerging Customer Engagement
20+ Years Industry Role in Pharma
USDM Life Sciences
Hovsep KirikianDirector of Product Management
15+ Years Experience Managing Projects
USDM Life Sciences

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