Document Authoring, Archive, and Inspection – Challenges And Tips For Establishing Audit-Proof Processes

Date: April 25, 2017
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

Training Session 3: The third session of this three-part Clinical Regulatory Document Management Compliance Professional (CRDMCP) certificate program will outline the all-important final steps of document archiving and audit readiness - both in paper and electronic formats.

Register now for the entire program at a significant discount!

Learning objectives, key drivers and pain points associated with this session topic: 

  • Transition to a digital versus paper environment
  • Extended retention periods for regulated documentation
  • Inspection readiness and the impact of inspection failure
  • Merger and acquisition – the ability to facilitate, expedite, and harmonize associated activities

Part A - Industry Best Practices: Document Authoring,  eCTD Publishing & Delivery, Archival Practices, Inspection Readiness, CRO Interactions, Product Dossier Tracking/Management, etc.

There is a potential for synergy between the EDMS and eCTD.  Organizations that make the best use of industry/agency standards, requirements, and best practices stand to benefit the most from these tools.  The best of these provide for a clear channel for staff, processes, technology and policies to interact and align, thus strengthening your firm’s chances for submission success.  Documents stored within an EDMS with appropriate meta-data applied by the author/contributor can smoothly move through review cycles and on to the publishing organization for production into an eCTD sequence deliverable. 

We will touch on the industry standards, regulatory requirements, and best practices associated with “making the connection.”

Part B - Regulatory Archive – Overview of the Why, What and How

The ability to produce evidence of the conduct of a clinical trial or research and development program is critical to the product’s value.  Whether the records and documentation is maintained and accessible within minutes or days, stakeholders from regulators to legal representatives to potential future owners of the product must be assured that the integrity of the documentation is assured.

We will share opportunities and best practices for processes – both legacy and forward looking.

Part C - Regulatory Inspection - Overview of the Why, What and How

The event of a regulatory inspection is pivotal in the life cycle of an investigational product…and it’s not a matter of if but when your organization will be inspected. We will explore various models of inspections at Sponsors, Clinical Research Organizations (CROs), and clinical sites from both clinical and regulatory perspectives. In this global regulated industry there are widely varying regional focuses. There is one absolute in this equation: the Sponsor is ultimately responsible for compliance.

Part D - Looking Forward: What regulations, standards and industry trends are underway and/or anticipated?

There are a number of recently released and upcoming regulations, regulatory guidelines, standards and industry trends.  We will briefly outline these and what their impact has been and could be going forward.

Examples: Trends with US FDA 483 Violations, EU Critical Findings Reports, Remote Inspections, Risk-Based Inspections

This session will be valuable to clinical trials and associated/related personnel responsible for archiving, storing, and organizing documents in a clinical setting.  This includes those responsible for audit readiness.  Finally, anyone who needs or wants to be conversant in these areas will find this course highly useful.

Betsy Fallen - Until recently, Betsy was with Merck where she spent several years in the data, regulatory and clinical operations areas. Betsy developed expertise in Essential Document Management, Trial Master Files and eTMF/eISF along with associated metrics as at Merck and on assignment with industry organizations including Metrics Champion Consortium. She is currently engaged with industry standards and best practices organizations such as the SAFE-BioPharma Association and the DIA TMF Reference Model working group. As an RN, Betsy is dedicated to leveraging technology to improve the patient experience as a clinical trial participant.

Dan Orfe - Dan is a Leadership professional with 20+ years experience in Regulatory eSubmission production. Subject matter expert for "cloud-based" eCTD & EDMS solutions and business process analyst for efficient submission assembly, dossier management and eCTD production. He has been a key member of several industry/agency initiatives to foster electronic submission standardization and efficiency. Dan presented or chaired sessions at several DIA Annual Meetings and DIA EDM Conferences. DIA Electronic Document Management (EDM) Conference Co-chair in 2009, 2010 & 2011. Program committee member for the DIA RSIDM Conference. Directed eSubmission production groups at Merck & Co., Inc. and Datafarm Inc.