2-days workshop on
Qualifying Foreign Vendors; Making Sure Your Foreign Vendor is FDA Compliant and Stays That Way
Coming soon.. Please contact customer care for new schedule at +1-510-857-5896
Course 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.

Learning Objectives
  • Vendor qualification and vendor disqualifications
  • Initiating audits
  • Planning for audits
  • Preparing audit schedules
  • Conducting on-site vendor audits
  • Rating foreign vendors for compliance
  • Maintaining successful foreign vendor-client relationships
  • Requalifying foreign vendors and performing follow-up audits
  • Key audit documentation requirements
Why Should you Attend
Participants in this 2 day workshop 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
  • Qualification documentation
  • Key components necessary in selecting the appropriate vendor
  • Successful vendor-client relationships
  • Appropriate vendor-client interactions
  • Auditing for GMP compliance
  • Audit/ Qualification rating scale
Who will Benefit
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Managers and Supervisors
  • People interested in the FDA-regulated industries
  • Auditors
Agenda

Day One:(8:30 a.m - 4:30 p.m)

(8:30 a.m. - 8:45 a.m.: Registration and Breakfast)

Speaker and Participant Introductions(8:45 a.m. - 9:00 a.m.)

Foreign Vendor Qualifications and Disqualifications((9:00a.m. - 10:00a.m.)
  • Responsibilities
  • Assessments
  • Review and Monitoring
  • Selecting qualified foreign vendors and suppliers
Break/networking(10:00a.m. - 10:15a.m.)

Contracted Service Provider Activities(10:15a.m. - 11:15a.m.)
  • Vendor and Supplier Management SOPs
  • Initial Training
  • QA Authorization
  • Communication
  • Documentation
Foreign Vendor and Supplier Audits(11:15a.m. - 12:00p.m.)
  • Understanding your foreign vendor or supplier
  • Your Foreign Vendor or Supplier’s Total Quality System
Lunch and networking(12:00p.m. - 1:00p.m.)

Foreign Vendor and Supplier Audits cont’d(1:00 p.m. - 2:00 p.m.)
  • Types of Audits and when to conduct them
Preparing the Audit Plan and communicating it with your Foreign Vendor or Supplier(2:00p.m. - 3:00p.m.)
  • Letter to Foreign Vendor or Supplier
  • Preparing the Audit Plan
  • Audit Plan Template
Break/networking(3:00p.m. - 3:15p.m.)

Proper Audit Conduct(3:15p.m. - 4:15p.m.)
Final questions/comments/discussion(4:15p.m. - 4:30p.m.)

Day Two:(8:30 a.m - 4:30 p.m)

(8:30 a.m. - 9:00 a.m.: Networking and Breakfast)

Foreign Vendor and Supplier Audit cont’d(9:00a.m. - 10:00a.m.)
  • Timing, keeping to schedule
  • Touring the facility
  • Taking notes and asking questions
(10:00a.m. - 10:15a.m.)Break

Evaluating your Foreign Vendor or Supplier’s Performance(10:15a.m. - 12:00p.m.)

  • Rating/Scoring Vendors and Suppliers
  • High to Low performers
  • Making Observations
  • Classifying Observations
(12:00p.m.- 1:00p.m.)Lunch

Audit Checklists(1:00p.m. - 2:00p.m.)
  • Checklist template
Document Review(2:00p.m. - 3:00p.m.)
  • SOPs
  • Policies
  • Organizational Charts
  • Batch Records
(3:00pm - 3:15pm)Break and networking

Exit meeting with your Foreign Vendor or Supplier(3:15p.m. - 4:15p.m.)
  • Observations and performance
  • Audit Report
  • CAPAs
Final questions/comments/ discussion(4:15p.m. - 4:30p.m.)

Joy McElroy - Principle Consultant, Maynard Consulting Company


Upon earning a degree in Zoology from 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.