6-Hour Virtual Seminar on Regulatory Compliance Auditing for Pharma Manufacturers

The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Compliance auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.

This seminar is designed for people tasked with performing internal and external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation. FDB3088

Learning Objectives:

  • Understand what a regulatory compliance audit is.
  • Understand the background and basics of regulatory compliance auditing.
  • Understand proper Auditor conduct.
    • Communication
    • Dress
    • Punctuality
    • Difficult situations
  • Learn the necessary skills for conducting audits.
  • Understand how to prepare and plan for a regulatory compliance audit.
  • Understand and know how to properly perform an audit.
    • Opening meeting
    • Touring the facility
    • Questions
    • Observations
    • Close out meeting
  • Understand the types of regulatory compliance audits
  • Learn proper questioning techniques
  • Understand proper audit observation classification
  • Learn to write an audit report
  • Understand conducting a follow up audit
  • Learn how to become Lead Auditor certified
    • ASQ Certification
    • ISO Certification
    • Medical Device Certification

Joy McElroy

Joy McElroy offers 14 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.

Lecture 1

Regulatory Compliance Auditing
– Audit background and basics
– Definitions
– What is an Audit?

Types of Regulatory Compliance Audits
– Internal Audits
– External Audits
      i) Supplier Audits
      ii) Distributor Audits
      iii) Due Diligence Audits

Lecture 2
Proper Auditor Conduct
– Communication
– Dress
– Punctuality
– Difficult Situations

Skills for Conducting Regulatory Compliance Audits
– Responsibilities
– Knowledge
– Techniques

Lecture 3
Preparing and Planning for a Regulatory Compliance Audit

Performing the Audit
– Opening Meeting
– Touring the facility
– Questions
– Observations
– Close- Out Meeting

Observation Classification
– Minor
– Major
– Critical

Lecture 3
Writing an Audit Report
– Time of delivery
– Cover letter
– Format of Report

Conducting a Follow-up Audit

Lead Auditor Certification Programs
– ASQ
– ISO
– Medical Device

  • Quality Management and Staff
  • Regulatory Affairs Management and Staff
  • Compliance Management and Staff
  • Manufacturing Management and Staff
  • Engineering Management and Staff
  • Operations Management and Staff
  • Production Management and Staff
  • Validation Management and Staff
  • Design Engineers
  • Process Owners
  • Documentation Departments
  • Quality Auditors

membership

JUST RELEASED
SEMINARS
&
WORKSHOPS
 





  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.