8:50 am Chair’s Opening Remarks

Operational Strategies for Complying with Global Regulations

9:00 am Panel Discussion: Developing a Roadmap to Achieving Global Regulatory Compliance

  • Harry Wolfgang Senior Manager, Technology Regulatory Compliance, Johnson & Johnson
  • Yves Samson CEO, e-Compliance SME, ECA Data Integrity & IT Compliance Group
  • Orlando Lopez E-Records Expert,

Synopsis

  • Defining the key differences between international regulations – particularly FDA and EMA
  • Developing a continuous compliance strategy in line with upcoming global updates
  • Communicating different regulatory requirements to different team members

9:45 am Updating Internal Guidance & Protocols When FDA Regulations Change

  • Harry Wolfgang Senior Manager, Technology Regulatory Compliance, Johnson & Johnson
  • Sanjeev Kumar Sr. Director - Data Integrity and Technology, Vertex Pharmaceuticals

Synopsis

• Interpreting and documenting new and upcoming regulatory changes
• Understanding requirements your team members should be aware of
• Effectively refreshing team members understanding

10:15 am Planning Data Transfer While Remaining Complaint with FDA and European Regulations

Synopsis

• Moving data from one cloud provider to another
• Migrating existing data into the cloud
• Removing outdated computer systems

10:45 am
Morning Coffee Break & Structured Networking Session

Effective Strategies for Long-Term Vendor Management

11:45 am Automating GxP Workflows and Maintaining Continuous Compliance

  • John Petrakis Vice President Cloud Assurance, USDM Life Sciences
  • Vishal Sharma Vice President of Digital Trust and Transformation, USDM Life Sciences

12:15 pm Defining Standards and Ownership of Data to be Complaint with FDA Regulations in an Automated World

Synopsis

• Leveraging regulatory, legal and internal policy considerations
• Establishing sustainable data access and rights for customers, vendors
• Certifying business continuity planning

12:45 pm Facilitated by the Conference Chair – Establishing the Responsibilities that Each Party is Accountable For

Synopsis

This interactive session will give you the opportunity to dive into the conversation
with your fellow colleagues to discuss, debate and get inspiration on how to
approach:

• Recognizing service level agreements to consider when designing contracts
• Documenting evidence for qualified infrastructure
• Understanding who validates each service

1:15 pm
Lunch Break & Networking

2:15 pm Fireside Chat: Creating Strong Mutually-Beneficial Working Relationship with Vendors

  • Daryn Berger Director, Information Technology, Relay Therapeutics
  • Cheryl Kussow Computer System Validation Leader, Corteva Agriscience

Synopsis

• Factoring transparency into long-term relationship building
• Creating trust between vendors and customers
• Developing strategies to ensure problems are addressed and questions answered in real time

3:00 pm Conducting Appropriate Site Inspections & Reviews

  • Yves Samson CEO, e-Compliance SME, ECA Data Integrity & IT Compliance Group

Synopsis

• Understanding vendor quality systems and objectives of a compliance audits
• Outlining the evidence required for an audit
• Creating tests to achieve the desired results

3:30 pm
Afternoon Coffee Break & Networking

4:00 pm Understanding the Business Models of Vendors

  • Chris Clayton Director of Information Technology, INCOG BioPharma

Synopsis

• Outlining vendor audits that ensure security of data and GxP compliance
• Attaining satisfactory documentation for compliance
• Planning for the future with a vendor

4:30 pm Round Table Discussions

  • Rimesh Gor Associate Director IT, Orchard Therapeutics

Synopsis

This interactive session gives you the opportunity to be part of the discussion –
to share ideas and learn from your peers. Choose the table most relevant to you
and get ready to be part of this conversation!

 

Perfecting Internal Audits Using Tools from Cloud
Providers
Understanding International
Regulations

5:15 pm Chair’s Closing Remarks