Vendor selection is a serious process. Manufacturers are responsible for compliance with their selected vendors

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar

"Ms. Joy L. McElroy 12 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries"

what qualifies a foreign vendor and what disqualifies a foreign vendor

Description

Vendor selection is a serious process. Manufacturers are responsible for compliance with their selected vendors. Any violations from the vendors can cause serious problems for the manufacturers. Choosing a foreign vendor is no different than choosing a domestic vendor. Foreign vendors are held to the same FDA standards as domestic vendors. Manufacturers have to have an assurance that their foreign vendor is suitable. They have to know the vendor will not be the source of major issues. Manufacturers are responsible for any vendor oversights or problems. In this seminar participants will understand how to make sure their foreign and domestic vendors are compliant and stay in compliance.

Why You Should Attend:

Participants in this seminar will learn what qualifies a foreign vendor and what disqualifies a foreign vendor for providing services and goods to your facility. They will learn how to initiate audits from foreign vendors and suppliers. Participants will learn how to relate to foreign vendors, and how to speak in common terms that are familiar to the foreign vendor and/or supplier as well as the manufacturer. Participants will gain an understanding of how to conduct on-site audits for foreign vendors. They will have an understanding of how to rate foreign vendors and maintain successful foreign -client relationships.

Areas Covered

  • Selection and Qualification documentation
  • Key components necessary in selecting the appropriate vendor
  • Successful vendor-client relationships
  • Appropriate vendor-client interactions
  • Auditing for GMP compliance
  • Audit Checklists
  • Audit / Qualification rating scale
  • Document Review  

Who will Benefit

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • Documentation Departments
  • Suppliers and Vendors Management Teams
  • Auditors

Industries who can attend

This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Joy McElroy

Joy McElroy Upon earning a degree in Zoology at North Carolina State University, She 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 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 over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. 

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. 

Upon earning a degree in Zoology at North Carolina State University, She 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 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 Ma

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