Quality Suppliers 2016 - Auditing Quality Suppliers and Vendors-By Compliance Global Inc

Overview:
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation.
Why Should You Attend:
Quality auditing training 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.
Areas Covered in this Webinar:
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
Learning Objectives:
Understand what a regulatory compliance audit is
Understand the background and basics of regulatory compliance internal audit report writing
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 handle auditor certification programs
ASQ Training & Certification
ISO Certification
Who Will Benefit:
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
Speaker Profile:
Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab.
In 1998, Ms. McElroy 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, she moved into equipment qualification and cleaning validation at Mallinckrodt.
With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.