Quality Control Laboratory Compliance - cGMPs and GLPs: One and a Half-day In-person Seminar
Bill Schwemer, Principal, Schwemer Consulting, Former Senior official with FDA's Office of the Commissioner
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FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.
This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).
Key goals of the conference will include learning:
Who will Benefit:
Senior directors, managers, supervisors and those who have responsibility for ensuring that QC laboratory operations and practices comply with current good manufacturing practices and good laboratory practices.
Meet Your Instructor
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.
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