Quality Control Laboratory Compliance - cGMPs and GLPs
Vice President, Americas Quality Operations
Boston College Club, MA
Vice President, Americas Quality Operations
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:
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.
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
General Driving Directions:Directions from Boston Logan International Airport
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.
See What People Say About Us
Speaker is very knowledgeable. Glimpses "behind the curtain" in to the FDA are quite valuable in my opinion. FDATrainingAlert has a broad catalog of professional advancement opportunities.
The seminar was very informative for the cGMP course over multiple areas (drug, device and food). The open forum for questions and discussions was very valuable. Registration process for the seminar with FDATrainingAlert was easy. Details of the course content were helpful. There was quick communication of required materials from FDATrainingAlert after the registration.
Speaker was informative. Contract laboratories topic was most valuable to me. Location was great. FDATrainingAlert staff was excellent in resolving the registration issues with hotel.
This seminar had a lot of excellent and useful information which will be beneficial for achieving compliance in our organization quality program. FDATrainingAlert is very good at communicating and working with me.
Speaker was very informative, interesting and nice. All topics were important to me. Nice hotel and I was happy I had a copy of slides prior to make notes on.
Overall it was good seminar. FDATrainingAlert was very good at email communication prior to the seminar.
The instructor was very knowledgeable and lab auditing topic was most valuable to me.
It was good seminar. All topics were valuable to me. It was good review of cGMP.
Overall it was good seminar. Informal conversation with other attendees was beneficial.
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