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Conducting Effective Auditing of GMP Documentation Workshop

August 10 @ 8:00 am - 5:00 pm

Conducting Effective Auditing of GMP Documentation Workshop

Register online

Dates Available

October 30, 2020

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $585.00 + HST

Location

Online

A One-Day COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOP

Receive a Credit toward the Diploma program in Pharmaceutical Quality Assurance and Quality Control

Course Overview

A compliant documentation system is of vital importance to a pharmaceutical company because it supports various important functions. It provides the legal proof that work was adequately planned and performed, it helps in the trouble-shooting of technical and managerial problems, it facilitates company growth and technology transfer, it provides a written history of company and products, and it proves to regulators that the company follows its commitments.

This training course provides participants the tools needed to perform in-depth audits of GMP documentation in the pharmaceutical, biopharmaceutical and medical device industries including insight on new regulations and methodologies, case studies to help benchmark current practices, and guidelines for following up with corrective actions.

Course Outline

  • Types of Regulated Documents
  • Regulatory Requirements for Documentation Review
  • Key Documentation Elements for:
    • GxP Documents:
      • Protocols and Reports
      • GMP Documents
      • Standard Operating Objectives
      • Batch Production Records
      • Methods and Specifications
      • Product Monograph
      • Out of Specification and Deviation Investigations
      • Rework Procedures
    • Product Development Summary Report
    • Method Development Report
    • Validation Protocols and Reports
    • Process
    • Equipment
    • Methods
    • Discussion of Effective Review Techniques
    • Industry Trends

WHO SHOULD ATTEND

This one-day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

  • Regulatory Affairs
  • Clinical Research
  • Quality Assurance
  • Documentation and Technical Writing
  • Product Submission
  • Project Management
  • Training
  • Product Development
  • Consultants
  • Others who interact together to launch a product

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.

Details

Date:
August 10
Time:
8:00 am - 5:00 pm

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