Why Should You Attend:
Vendor selection is a serious process. Manufacturers are responsible for compliance from 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 assurance that their foreign vendor is suitable. They have to know the vendor will not be the source for major issues as Manufacturers are responsible for any vendor oversights or problems.
In this webinar attendees will learn how to effectively qualify foreign vendors and suppliers. What are key components necessary in selecting the appropriate foreign vendor, as well as how to create and maintain successful foreign vendor-client relationships through appropriate communication. Attendees will learn how to conduct proper and thorough foreign vendor on-site audits, along with how to correctly and efficiently audit foreign vendors for GMP compliance and create a scoring system for the vendors.
Areas Covered in the Webinar:
Vendor qualification and vendor disqualifications
Key components necessary in selecting the appropriate vendor
Successful vendor-client relationships
Appropriate vendor – client interactions
Conducting an On-site audit
Auditing for GMP compliance
Key documentation requirements
Vendor selection is a serious process. Manufacturers are responsible for compliance from 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 assurance that their foreign vendor is suitable. They have to know the vendor will not be the source for major issues as Manufacturers are responsible for any vendor oversights or problems.
In this webinar attendees will learn how to effectively qualify foreign vendors and suppliers. What are key components necessary in selecting the appropriate foreign vendor, as well as how to create and maintain successful foreign vendor-client relationships through appropriate communication. Attendees will learn how to conduct proper and thorough foreign vendor on-site audits, along with how to correctly and efficiently audit foreign vendors for GMP compliance and create a scoring system for the vendors.
Areas Covered in the Webinar:
Vendor qualification and vendor disqualifications
Key components necessary in selecting the appropriate vendor
Successful vendor-client relationships
Appropriate vendor – client interactions
Conducting an On-site audit
Auditing for GMP compliance
Key documentation requirements
Speakers
Upon earning a degree in Zoology at 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 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.
