The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality 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.
• Understand what a regulatory compliance audit is.
• Understand the background and basics of regulatory compliance auditing.
• Understand proper Auditor conduct.
o 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.
o Opening meeting
o Touring the facility
o 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
o ASQ Certification
o ISO Certification
• Regulatory Compliance Auditing
• Types of Regulatory Compliance Audits
• Proper Auditor Conduct
• Skills for Conducting Regulatory Compliance Audits
• Preparing and Planning for a Regulatory Compliance Audit
• Performing the Audit
• Observation Classification
• Writing an Audit Report
• Conducting a Follow-up Audit
• Lead Auditor Certification Programs
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This 90 minute overview 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. The following personnel will benefit from the course:
• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Validation engineers
• Manufacturing engineers
• Production engineers
• Design engineers
• Process owners
• Quality engineers
• Quality auditors
• Document control specialists
Joy L. McElroy,
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.
Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.
In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off - site training to pharmaceutical and biotech companies throughout the United States.
Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.