Ensuring Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists


2-Day In-Person Seminar, from COMPLIANCE TRAININGS (Code – SEM9058)

Ensuring Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists


   


      Joy McElroy

    San Diego, CA, USA

 


    March 21 – 22, 2019

1 DELEGATE

3 DELEGATES

5 DELEGATES

$ 1200

(Save $ 300) 🛈

$ 1080 / Delegate

(Save $ 1260) 🛈

$ 960 / Delegate

(Save $ 2700) 🛈

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Seminar DescriptionAgendaSpeakerPricingVenue
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 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.


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

 

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 Should Attend:

 

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

 

DAY 1 (8.30 AM – 4.30 PM):

Registration Process – (8.30 AM – 9:00 AM)

Foreign Vendor Qualifications and Disqualifications
– Responsibilities
– Assessments
– Review and Monitoring
– Selecting qualified foreign vendors and suppliers

Contracted Service Provider Activities
– Vendor and Supplier Management SOPs
– Initial Training
– QA Authorization
– Communication
– Documentation

Foreign Vendor and Supplier Audits
– Understanding your foreign vendor or supplier
– Your Foreign Vendor or Supplier’s Total Quality System

Foreign Vendor and Supplier Audits cont’d
– Types of Audits and when to conduct them

Preparing the Audit Plan and communicating it with your Foreign Vendor or Supplier
– Letter to Foreign Vendor or Supplier
– Preparing the Audit Plan
– Audit Plan Template

Proper Audit Conduct

Final questions / comments / discussion

DAY 2 (8.30 AM – 4.30 PM):

 

Foreign Vendor and Supplier Audit cont’d
– Timing, keeping to schedule
– Touring the facility
– Taking notes and asking questions

Evaluating your Foreign Vendor or Supplier’s Performance
– Rating/Scoring Vendors and Suppliers
– High to Low performers
– Making Observations
– Classifying Observations

Audit Checklists
– Checklist template

Document Review
– SOPs
– Policies
– Organizational Charts
– Batch Records

Exit meeting with your Foreign Vendor or Supplier
– Observations and performance
– Audit Report
– CAPAs

Final questions / comments / discussion

Joy McElroy

Co-Owner of Maynard Consulting Company


 

Joy McElroy offers 14 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.

PRICING OPTIONS
For Single Delegate – $ 1200 (Save $ 300 on Early Bird Discount)
Regular Price – $ 1500

Get 10% Discount on Group of 3 Delegates – $ 1080 / Delegate on Early Bird Offer (Save $ 1260)
Get 20% Discount on Group of 5 Delegates – $ 960 / Delegate on Early Bird Offer (Save $ 2700)

EARLY BIRD OFFERS CLOSES ON   MARCH 7, 2019
 
 
 
 
Early bird seats are limited and based on first-come, first-serve.
 

For discounts on multiple registrations, contact customer care at +1-416-915-4458

 
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Payment Options

Register Online:

  • Make Secure Payment using Credit Card
  • Click on Register Now, and you will be redirected to Payment Options page.
  • Please choose your option (No. of delegates) from the drop down and click on Add to basket
  • Click on Proceed to Checkout on the Cart Page, and complete the registration.
  • Once the payment is completed, you will be receiving a Form to fill up the Delegates Information
  • An electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date.
  • Please bring the respective passes to the event venue.


Pay by Wire:

  • Please contact our support to assist you with registration by Wire
  • Support Number: +1-416-915-4458
  • E-mail: info@webinarcompliance.com

By Check:

  • Pay your check to (payee name) “FutureCorp Consulting Inc” our parent company
  • Please send the Scanned copy of the check to info@webinarcompliance.com
  • Mail the check to:
    FutureCorp Consulting Inc
    5939, Candlebrook Ct.,
    Mississauga, ON L5V 2V5,
    Canada
  • Once we receive the check, you will be receiving a Form to fill up the Delegates Information
  • After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.
 

San Diego, CA, USA

(Venue to be announced shortly)
March 21 – 22, 2019

Call for Assistance: +1-416-915-4458   Register Now