Sponsored Webcast: Achieving 21 CFR 11 Compliance with Cloud-Deployed Systems

1.0
RAC Credits
Wednesday, 28 August 2019 (12:00 PM) - Wednesday, 28 August 2019 (1:00 PM)
Sponsored by:




The eCTD mandate for all commercial INDs subjects small and early stage companies to FDA scrutiny in order to ensure their compliance with 21CFR11.  Furthermore, all commercial companies must comply with 21CFR11.  This is compounded by the need to comply with current eCTD electronic records format and the requirement for electronically signing a variety of documents.   To add to the complexity, documents must be submitted to the FDA using their Electronic Submission Gateway.                              

This webcast will offer tips for success in selecting and implementing cloud-deployed solutions.  We will describe the challenges faced by small FDA-regulated companies in managing and controlling the content of eTMF, eCTD and QMS.  We'll also deliver the framework for empowering early-stage and virtual companies to gain control of content beginning with discovery.  Our goal is to provide you with:

      • information to be used for rapid deployment of a system that complies with 21CFR11.
      • solutions on how to comply with the regulation as your organization grows and makes investments in clinical, nonclinical and manufacturing development.
      • insights for creating a robust system that matures with company requirements and is capable of supporting migration of content to/from partners and vendors.


Learning Objectives

Upon the webcast's conclusion, you will be able to: 
  • Assess your company’s overall compliance with 21CFR11
  • Review your company’s staffing and infrastructure for gaps in 21CFR11 compliance
  • Identify potential deployment models to close the gaps
  • Develop a budget and timeline for implementing 21CFR11 compliant systems
  • Describe the requirements for eTMF, eCTD and QMS solutions


Who Should Attend?

  • Chief Medical Officer
  • Chief Clinical Officer
  • Head of Quality Management
  • Head of Clinical Quality Assurance
  • Head of R&D
  • Head of Data Management
  • Head of Information Technology
  • Regulatory Affairs and Regulatory Operations staff

Speakers


Antoinette Azevedo, co-founder, RegDocs365, LLC
Antoinette Azevedo co-founded RegDocs365, LLC along with Keith Parent, to solve a serious unmet need in life sciences: to bring a fully-validated cloud-deployed content management system to companies in development stage who do not have budgets and staffing to implement in-house validated systems.  In designing RegDocs365’s solution, Azevedo built upon her over 25 years of experience implementing document management and submission publishing systems in North America and Europe.  Antoinette is also the founder of e-SubmissionsSolutions.com, Sage Submissions, eSubmissions University and was a course instructor for RAPS from 2007-17 on preparing for the eCTD mandates.
 
Keith Parent, co-founder, RegDocs365, LLC
Having more than 30 years’ experience in the field of information technology, Keith Parent is the founder and CEO of Court Square Group, and Co-Founder of RegDocs365. Parent oversees Court Square Group’s Life Sciences practice as well as technology focused practices in Network and Security, SharePoint and Managed Services. He spearheaded the formation of the Audit Ready Compliant Cloud (ARCC) environment based on “GSP – Good System Practice,” providing a secure hosting environment for validated applications. Parent has an extensive technical background, including large scale software development, global infrastructure management and multi-industry integration project experience. He holds an MS in Computer Science from Rensselaer Polytechnic Institute. Parent currently sits on the Board of Directors for the Pioneer Valley Life Science Institute (PVLSI).
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