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      Quality Control Laboratory Compliance - cGMPs and GLPs in Boston

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      April 16, 2020

      Thursday   8:30 AM - 1:00 PM (daily for 2 times)

      Boston, Massachusetts, United States
      Boston, Massachusetts

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      Quality Control Laboratory Compliance - cGMPs and GLPs

      Quality Control Laboratory Compliance - cGMPs and GLPs
      About this Event


      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).

      Seminar Fee Includes:


      AM-PM Tea/Coffee

      Seminar Material

      USB with seminar presentation

      Hard copy of presentation

      Attendance Certificate

      $100 Gift Cert for next seminar

      Learning Objectives:

      Key goals of the conference will include learning:

      The basics of FDA law and regulations governing QC laboratories responsible for testing research materials, components of FDA-regulated products, and finished FDA-regulated products (pharmaceuticals, biologics, medical devices, cosmetics, and foods).
      Laboratory organization, personnel qualification and training requirements.
      Documentation and record-keeping requirements, including e-records and data integrity.
      Sample integrity requirements.
      Management and control of stability (shelf-life) studies.
      Analytical methods verification and validation.
      Management and control of laboratory instruments.
      Management and control of laboratory supplies.
      Proper conduct of laboratory investigations.
      Consequences of laboratory non-compliance.
      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.

      Quality Assurance
      Quality Control
      Research & Development

      DAY 01(8:30 AM - 4:30 PM)

      08.30 AM - 09.00 AM: Registration

      09.00 AM: Session Start

      Basics of FDA law and regulations for QC laboratories

      What is adulteration?



      Medical Devices



      What is CGMP?



      Medical Devices



      What is GLP?

      What is AIP?

      Contract Laboratories

      FDA inspection methodology

      Laboratory Organization


      Personnel qualification and training

      Documentation and record-keeping requirements

      Standard Operating Procedures

      Analytical Methods

      Raw data (notebooks, print-outs)

      Document management (change control, retention)

      Part 11 (electronic records and signatures)

      Sample integrity requirements

      Sample collection

      Sample delivery, handling, disposition

      Retain samples

      Stability (shelf-life) studies

      Organization and management

      Storage units

      Analytical methodology

      DAY 02(8:30 AM - 1:00 PM)

      Analytical methods verification and validation




      Management and control of laboratory instruments




      Management and control of laboratory supplies


      Reagents, chemicals

      Proper conduct of laboratory investigations

      Out-of-specification results

      Out-of-norm results

      Root cause analysis


      Consequences of laboratory non-compliance


      Kelly Thomas

      Vice President, Americas Quality Operations

      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.

      Cost: $2,099

      Categories: Conferences & Tradeshows

      This event repeats daily for 2 times:

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.

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