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).

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

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(9:00 AM - 4:00 PM ET)
  • 09.00 AM: Session Start
  • Basics of FDA law and regulations for QC laboratories
    • What is adulteration?
      • Pharmaceuticals
      • Biologics
      • Medical Devices
      • Foods
      • Cosmetics
    • What is CGMP?
      • Pharmaceuticals
      • Biologics
      • Medical Devices
      • Foods
      • Cosmetics
    • What is GLP?
    • What is AIP?
    • Contract Laboratories
    • FDA inspection methodology
  • Laboratory Organization
    • 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(9:00 AM - 4:00 PM ET)
  • Analytical methods verification and validation
    • Protocols
    • Tests
    • Documentation
  • Management and control of laboratory instruments
    • Qualification
    • Calibration
    • Maintenance
  • Management and control of laboratory supplies
    • Standards
    • Reagents, chemicals
  • Proper conduct of laboratory investigations
    • Out-of-specification results
    • Out-of-norm results
    • Root cause analysis
    • Documentation
  • Consequences of laboratory non-compliance
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Kelly Thomas

Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer

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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,499.00

(One Dial-in One Attendee)

May 8-9, 2024, Virtual Seminar
(Registrations till Mar 15, 2024 - $1499)
(Registrations after Mar 15, 2024, 2023 - $1899)

$7,999.00

Group-Max. 10 Attendees

May 8-9, 2024, Virtual Seminar
(Registrations till Mar 15, 2024, 2023 - $7999)
(Registrations after Mar 15, 2024, 2023 - $9,999)



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We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

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Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
Offers:
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  • Testimonials

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    Speaker is very knowledgeable. Glimpses "behind the curtain" in to the FDA are quite valuable in my opinion. ComplianceOnline has a broad catalog of professional advancement opportunities.

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    Quanterix Corporation

    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 ComplianceOnline was easy. Details of the course content were helpful. There was quick communication of required materials from ComplianceOnline after the registration.

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    Procter & Gamble

    Speaker was informative. Contract laboratories topic was most valuable to me. Location was great. ComplianceOnline staff was excellent in resolving the registration issues with hotel.

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    Estée Lauder Companies

    This seminar had a lot of excellent and useful information which will be beneficial for achieving compliance in our organization quality program. ComplianceOnline is very good at communicating and working with me.

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    Alaffia

    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.

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    Overall it was good seminar. ComplianceOnline was very good at email communication prior to the seminar.

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    International Flavors & Fragrances Inc.

    The instructor was very knowledgeable and lab auditing topic was most valuable to me.

    Food Safety and Quality Coordinator,

    The Raymond-Hadley Corporation

    It was good seminar. All topics were valuable to me. It was good review of cGMP.

    Quality Control Analyst,

    Fagron

    Overall it was good seminar. Informal conversation with other attendees was beneficial.

    Manager Quality Engineering,

    Nuskin Products, Inc

    The instructor was outstanding and very knowledgeable and shared great examples which really clarified the application of course material.

    Sr. VP Operations,

    Hologic Gen-Probe

    Great experience, very valuable. The instructor gave lot of great examples.

    Sr. Director QC,

    Hologic Gen-Probe

    Some of the anecdotes were useful, all were entertaining and informative in the general/public policy/historical sense. The ComplianceOnline responded promptly to questions.

    Quality Control Manager,

    ProZyme, Inc.

    The instructor was experienced and knowledgeable.

    QA/QC Manager,

    Nellson Nutraceutical

    Sample SOPs were a good idea.

    QA Manager,

    Specialty Silicone Fabricators, Inc.

    Side notes' brought up by the presenter was interesting.

    QC Lab Manager,

    Usana Health Sciences

    The presenter was extremely versatile/knowledgeable across the GxPs.

    GxP Vendor Compliance Management,

    AbbVie Laboratories

    The presenter has a lot of experience in a variety of areas and shared stories and examples that helped in better understanding and were interesting.

    Lab Manager,

    PaxVax, Inc.

    The presenter was very knowledgeable and the presentation was excellent.

    Associate Professor,

    University of Miami

    The instructor was knowledgeable and experienced.

    Quality Control Manager,

    Earthrise Nutritionals

    Seminar provided broad overview of what the FDA is looking for during lab inspections.

    Senior Scientist,

    Clorox Services Company

    SThe instructor had so much experience and gave lot of examples that make the information easy to understand.

    Scientist I,

    ViaCyte, Inc

    TI had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.

    Director of Regulatory Affairs,

    Nickell Physician & Pharmacy Services

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