Quality Oversight & Governance Business Process Overview

Introduction

Purpose

What Is the Purpose of This Course?

All applicable R&D personnel will be aware of the end-to-end process for R&D Quality Oversight and Governance process and obtain a comprehensive view of all documents and resources associated with the business process.

Learning Objectives

Upon completing this course, you will be able to:

  • State the purpose, scope and reason that R&D has a Quality Oversight and Governance process for R&D business processes
  • Identify sub-processes and descriptors
  • Identify key interactions and critical awareness for inputs, outputs and touchpoints.
  • Review all process roles and identify potential roles applicable to the work the learner may perform.
  • Review all process documents and identify documents applicable to work the learner may perform
  • Identify where in the R&D PON the process is captured to know where to find additional information and resources in the future

Overview

R&D Processes

The Process Owner Network Diagram below shows how Quality Oversight & Governance fits into the overall set of R&D processes. Hover your mouse over each process to learn more.

Quality Oversight & Governance Sub-Processes and SOPs

The following sections describe the sub-processes and SOPs associated with Quality Oversight and Governance. There are four main sub-processes:

  • Manage Inspections
  • Perform Audits
  • Quality Governance and Issue Management
  • CAPA/Trackwise Process

Each section includes a listing of the SOPs associated with each sub-process, along with the roles required to execute each SOP. Review the roles carefully for each SOP, and if your role is listed, click on the link for that SOP to read and acknowledge that you understand and are committed to fulfilling your role.

Manage Inspections

Manage Inspections Overview

Manage Inspections

This sub-process includes all three SOPs within the Quality Oversight and Governance Business Process Overview. The SOPs associated with Manage Inspections include:

  • DEV-SOP-771 Managing Regulatory Agency Inspections at the Biogen UK Site
  • DEV-SOP-1158 Management of Regulatory Inspections at US R&D Sites
  • DEV-SOP-1283 Managing Regulatory Inspections at Investigator Sites

This sub-process also includes associated JA information critical to R/A roles, and includes links to associated controlled documents within the PON site.

SOPs

DEV-SOP-771 Managing Regulatory Agency Inspections at the Biogen UK Site

Purpose

The purpose of this SOP is to describe the preparation process and procedure for hosting regulatory inspections by regulatory agencies (e.g., Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and Food and Drug Administration (FDA) at Biogen's offices in the United Kingdom (UK).

Scope

This SOP applies to on-site announced and unannounced visits to the Biogen UK site by regulatory agencies for the conduct of a Good Clinical Practice or Pharmacovigilance Inspection.

Note that DEV-SOP-771 applies to the UK only. Please refer to the SOP for further detail.

Roles

The roles associated with this SOP include:

  • Recipient
  • RDQC QRM
  • Head of RDQC
  • Host
  • Security
  • SME
  • Scribe
  • Runner
  • RDQC organization (includes UK and R&D Quality Affiliate roles)

If your role is listed above, please click on the link below to access and read DEV-SOP-771.

Managing Regulatory Agency Inspections at the Biogen UK Site

DEV-SOP-1158 Management of Regulatory Inspections at Biogen US R&D Sites

Purpose

The purpose of this SOP is to establish a systematic process for the management of Good Clinical Practice (GCP), good Pharmacovigilance Practices (GVP) for the European Union, and Goog Laboratory Practice (GLP) compliance inspections...

Scope

This SOP applies to announced and unannounced inspections by regulatory agencies...


Roles

The roles associated with this SOP include:

  • Recipient
  • RDQC QRM
  • Head of RDQC
  • Host
  • Security
  • SME
  • Scribe
  • Runner
  • RDQC organization

If your role is listed above, please click on the link below to access and read DEV-SOP-771.

Management of Regulatory Inspections at Biogen US R&D Sites

DEV-SOP-1283 Managing Regulatory Inspections at Investigator Sites

Purpose, Scope, Roles

The purpose, scope, roles, and link to DEV-SOP-1283 would be included here and follow the same general structure as the above sections.

Perform Audits

Perform Audits Overview

Perform Audits

This sub-process includes all three SOPs within the Quality Oversight and Governance Business Process Overview. The SOPs associated with Perform Audits include:

  • DEV-SOP-1708 GVP Strategic Audit Planning
  • DEV-SOP-1896 GCP, GLP and GVP Tactical Audit Planning
  • DEV-SOP-1897 RDQC Execution of Audits

SOPs

SOPs for Perform Audits

This section would include purpose, scope, roles, and links to the following SOPs:

  • DEV-SOP-1708 GVP Strategic Audit Planning
  • DEV-SOP-1896 GCP, GLP and GVP Tactical Audit Planning
  • DEV-SOP-1897 RDQC Execution of Audits

Quality Governance & Issue Management

Quality Governance & Issue Management Overview

Quality Governance & Issue Management

This sub-process includes all three SOPs within the Quality Oversight and Governance Business Process Overview. The SOPs associated with Quality Governance & Issues Management include:

  • DEV-SOP-1899 Serious Breach of GCP
  • DEV-SOP-1898 Quality Issue Detection and Excalation
  • DEV-SOP-1095 Management of R&D Compliance Trackwise Flows

SOPs

SOPs for Quality Governance and Issues Management

This section would include purpose, scope, roles, and links to the following SOPs:

  • DEV-SOP-1899 Serious Breach of GCP
  • DEV-SOP-1898 Quality Issue Detection and Excalation
  • DEV-SOP-1095 Management of R&D Compliance Trackwise Flows

CAPA/Trackwise Process

CAPA/Trackwise Process Overview

CAPA/Trackwise Process

This sub-process includes one SOP and reference to CAPA/Trackwise ILT within the Quality Oversight and Governance Business Process Overview, including:

  • DEV-SJA-2071 Requesting New/Modifying User Access to R&D Trackwise Flows

SOPs

Job Aid for CAPA/Trackwise Process

This section would include purpose, scope, roles, and link to DEV-SJA-2071 Requesting New/Modifying User Access to R&D Trackwise Flows.

Sample Interactions

Fill In the Blanks Question (Type "Answer 1")

 

Text Matching Question

Match the correct number to the equation.

  • 1 plus 2 equals
    3
  • 2 plus 3 equals
    5
  • 3 plus 4 equals
    7

Multiple Choice Question

Add question here...

  • Response 1
  • Response 2
  • Response 3

Single Choice Image Question

Which image looks like a life preserver?

Summary

Summary

Summary text goes here

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.

Additional info goes here

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.