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.
Who Should Attend
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
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