QT101: Writing & Managing Documents for Compliance in Regulated Industry

A practical 3-day course to help you...

  • Understand the role of SOPs in documenting cGTP , QSR, and cGMP operations
  • Understand the difference between SOPs, Policies, Work Instructions, and Specifications.
  • Understand regulatory agency and industry expectations.
  • Identify responsibilities for document preparation, review, and approval.
  • Use appropriate formatting and technical writing techniques.
  • Analyze the adequacy of existing SOP systems.
  • Document and Data control systems.

 

Know How to Implement and Use a Successful Document Development and Control Program
Learn Effective Principles in Writing SOPs, Policies and Specifications
Learn Good Documentation Practices.

Policies, SOPs, and Specifications are the primary means used within the human tissue, medical device, pharmaceutical, and other FDA-regulated industries to describe what and how operations are performed. They are a basic requirement of Current Good Tissue Practice (cGTP), Quality Sys-tem Regulations (QSR), Current Good Manufacturing Practice (cGMP) regulations globally, as well as ISO 9001 and ISO 13485 Quality Management Systems, and are regarded by regulatory agencies as a rigid, legal written commitment. Thus SOPs are among the main documents scrutinized by the agencies during their inspections.

This practical course defines the different types of documents required in regulated industries (i.e., SOPs, Policies, Forms, and Specifications), and covers the various elements you must consider to ensure that your organization’s individual documents and the SOP program for cGTP, QSR, and cGMP operations are effective and efficient.

 

Key Learning Objectives

  • The difference between policies, SOPs, and Specifications.
  • The role of SOPs in regulated documentation systems.
  • Regulatory agency and industry expectations.
  • Determining the role of the different types of documents, and what documents need to be written.
  • Analyzing existing SOPs to determine gaps and overlap in regulatory coverage.
  • Needs for different types of documents.
  • Typical formats used in Quality documents.
  • Determining who should prepare, approve and authorize SOPs.
  • Understanding and describing operational flow.
  • Assessing what level of detail to address.
  • Writing accurately, clearly, unambiguously and succinctly.
  • Printing techniques that help make SOPs easy to read and understand.
  • Managing effectively and efficiently the document and data control system.
  • Defining responsibilities, handling tracking and revisions, compiling the SOP on SOPs, and understanding SOP costs.
  • Archiving documents to retain a historical perspective.

 

Who Will Benefit

This course will benefit all who are involved in the preparation, implementation or management of individual SOPs or of the SOP system for GMP operations. Typically it will assist personnel from all phases of production and quality operations and relevant personnel from R&D. These areas of responsibility include:

  • Quality Assurance/Quality Control.
  • Senior Management.
  • Regulatory affairs.
  • Tissue Recovery personnel.
  • Purchasing.
  • Production (including manufacturing, labeling, and packaging).
  • Warehousing/distribution.
  • Maintenance/engineering.
  • Technical Services.
  • Clinical supply management.
  • Anyone in your organization with as-signed responsibility for writing policies, SOPs, and/or Specifications.

Download the Course Brochure

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