Quality Control Laboratory Compliance - cGMPs and GLPs
Consultant, EAS Consulting Group, LLC
San Francisco, CA
Consultant, EAS Consulting Group, LLC
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.
Mr. Fish has been providing independent consulting services since 2003, joining EAS Consulting Group, LLC in November 2006. Prior to that he started work for AAC Consulting Group, Inc. (AAC) in April 1995 after serving 33 years with Food and Drug Administration (FDA). The last 6 years of that service he held the position of Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections' operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office for 8 years and was also a Supervisory Investigator at the Nashville District Office for 8 years. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962, and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, dietary supplements, tobacco, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor.
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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