Course Catalog

Effective Auditing/Inspection Process for Pharmaceutical Laboratories

Laboratory activities are one of the main functions in Pharmaceutical Industry. In the current time, analytical chemists are involved in several audits or inspections either as an auditor/inspector or as someone being audited / inspected. We are also required to evaluate other laboratories, Contract Research Organizations (CROs) or vendors/suppliers. Understanding the auditing process has proved to be beneficial to handle your internal and external audits. Effective auditors can help to achieve and maintain quality management system registration as well as identify opportunities to improve overall performance. This course will present critical information of an auditing process, how to handle observations, prepare auditing checklists, discuss findings and follow up plan.

Course Details

Key Topics

  • Understand the main objectives for conducting laboratory audit and inspections
  • Discuss how to prepare for conducting an audit
  • Learn how to assembling an audit team
  • Identify the areas of deficiencies
  • Review the do?s and don?ts during the audit
  • Prepare the audit report
  • Discuss follow-up activities

Information

Laboratory activities are one of the main functions in Pharmaceutical Industry. In the current time, analytical chemists are involved in several audits or inspections either as an auditor/inspector or as someone being audited / inspected. We are also required to evaluate other laboratories, Contract Research Organizations (CROs) or vendors/suppliers. Understanding the auditing process has proved to be beneficial to handle your internal and external audits. Effective auditors can help to achieve and maintain quality management system registration as well as identify opportunities to improve overall performance. This course will present critical information of an auditing process, how to handle observations, prepare auditing checklists, discuss findings and follow up plan.

Who Should Attend

This course will benefit analytical chemists or investigators who involve with internal or external audits or inspections, evaluating new laboratories and/or selecting new vendors. You must have at least 2 years experience in pharmaceutical industry to get the full benefit of this course.

Benefits

This course will help an analyst to understanding the auditing process better and better prepared for internal or external audits. It will present critical information of an auditing process, how to handle observations, prepare auditing checklists, discuss findings and follow up plan.

Agenda

  • Understand Quality System and Documentation Structure
    • Elements of an Audit Plan
    • Purpose of Audit and Inspection
    • Identify auditing areas
    • Preparation of Checklists
  • Conducting the Audit
    • Opening Meeting
    • Interviewing and Making Observations
    • Verifying Information
    • Ask the right question
    • Keeping records
  • Audit Reporting and Follow Up:
    • Writing the Observations
    • Reporting the Audit
    • Close Out Observations
    • Discuss Corrective and Preventive Actions

Course Locations

Date

TBA

Check-in opens at 7:30 a.m. on the day of the course.

Course runs from 8:30 a.m. to 5:00 p.m.

Register Via Mail

Venue

The course fee includes a course binder and a continental breakfast each day.

Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax or mail and mention this discount. May not be combined with any other offer.


Pricing
  Member Non-Member
Advanced $895 $1,095
Standard $1,095 $1,295

About the Instructor

  • Kim Huynh-Ba

    has almost 28 years of experience in GMPs, analytical development and stability sciences in Pharmaceutical Industry.