Webinars >>FDA Regulations
How to Make Sure Your Foreign Vendor is FDA Compliant and Stays That Way 
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In a FDA-regulated industry, sponsor companies are only as compliant as their vendors. Any violations at the vendor are liabilities for the sponsoring company. The sponsor is held responsible for its poor vendor selection, and lack of vendor oversight. With increasing globalization of operations, vendors for all aspects of development are involved at all geographic locations. Most discussions for foreign vendor qualification are limited to manufacturing operations while clinical trials, centralized labs, and animal testing facilities have an almost equal probability of being located at a foreign site. It works both ways; sponsors using bad vendors suffer the financial, regulatory and legal consequences, while for vendors with bad history, it is hard to find new business. Hence, just like the sponsor, vendors also need to assure that the client is suitable and will not cause major issues later.
Why should you attend:
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This webinar, presenting by a leading quality assurance industry expert will discuss FDA expectations from vendor qualification. Practical issues with foreign vendors will be discussed with specific case studies with vendors from common regions of the world with many vendors. The seminar will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting practices for FDA regulated industry using case studies and examples from the presenter’s vast experience helping companies big and small find vendors world-wide. Similarly the vendor perspective in finding the appropriate client will be discussed. The webinar will provide precise and complete list of measures and checklists to be implemented by FDA-regulated companies to bullet-proof their vendor selection, management and supervision. This seminar will provide sponsor companies with the necessary tools to make an informed decision when qualifying a vendor’s compliance.  Conversely, the session will provide vendors with proven techniques to win sponsor business and exceed regulatory and performance expectations.
Areas Covered in the Session:
  • The top five vendor qualification and vendor mistakes – how parties can avoid them
  • Key components for the vendor selection process
  • Factors governing successful vendor-client relationship
  • Best practices for vendor interactions and the selection process
  • When to do an on-site audit and when to avoid it
  • Auditing for GMP, GCP and GLP compliance
  • Rules for information FDA about selected vendors
  • Key documentation requirements
Who will benefit:
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry
Date: November 18, 2020
​Duration: ​60 Minutes
​Time: 12 PM EST

Speaker: Mukesh Kumar​
​PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com