Auditing and Qualifying Suppliers and Vendors

Duration: 90 Minutes

$390

Faculty: JOY MCELROY
Product ID: FDB3053

Purchase Options: *

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Description

This training program is designed for people tasked with performing 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 system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.

The various regulatory agencies have expectations that suppliers and vendors 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.

Areas Covered in the Session :

Understand what a supplier and vendor audit is
Understand the background and basics of supplier and vendor 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 supplier and vendor audit
Understand and know how to properly perform an audit
- Opening meeting
- Touring the facility
- Questions
- Observations
- Close out meeting
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

Who Should Attend:

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

Course Director: JOY 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.

Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach

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Course Director: JOY MCELROY

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