Quality Control Laboratory Compliance – cGMPs and GLPs: One and a Half-day In-person Seminar

By: Robert C Fish, Consultant, EAS Consulting Group, LLC
Location 1:- DoubleTree by Hilton San Francisco Airport, CA
Thursday, March 22, 2018 | Friday, March 23, 2018
Location 2:- Philadelphia, PA
Thursday, May 31, 2018 | Friday, June 1, 2018

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Course Description:

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

Course Outline:

Day One (8:30 AM - 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

  1. Basics of FDA law and regulations for QC laboratories
    1. What is adulteration?
      1. Pharmaceuticals
      2. Biologics
      3. Medical Devices
      4. Foods
      5. Cosmetics
    2. What is CGMP?
      1. Pharmaceuticals
      2. Biologics
      3. Medical Devices
      4. Foods
      5. Cosmetics
    3. What is GLP?
    4. What is AIP?
    5. Contract Laboratories
    6. FDA inspection methodology
  2. Laboratory Organization
    1. Organization
    2. Personnel qualification and training
  3. Documentation and record-keeping requirements
    1. Standard Operating Procedures
    2. Analytical Methods
    3. Raw data (notebooks, print-outs)
    4. Document management (change control, retention)
    5. Part 11 (electronic records and signatures)
  4. Sample integrity requirements
    1. Sample collection
    2. Sample delivery, handling, disposition
    3. Retain samples
  5. Stability (shelf-life) studies
    1. Organization and management
    2. Storage units
    3. Analytical methodology
Day Two (8:30 AM - 1:00 PM)
  1. Analytical methods verification and validation
    1. Protocols
    2. Tests
    3. Documentation
  2. Management and control of laboratory instruments
    1. Qualification
    2. Calibration
    3. Maintenance
  3. Management and control of laboratory supplies
    1. Standards
    2. Reagents, chemicals
  4. Proper conduct of laboratory investigations
    1. Out-of-specification results
    2. Out-of-norm results
    3. Root cause analysis
    4. Documentation
  5. Consequences of laboratory non-compliance

Meet Your Instructor

Robert C Fish
Robert C Fish
Consultant, EAS Consulting Group, LLC

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.


Location 1:
DoubleTree by Hilton San Francisco Airport
835 Airport Blvd,
Burlingame, CA, 94010-9949, USA

March 22-23, 2018

How to Reach

General Driving Directions:

Directions from San Francisco International Airport, CA: 4.8 mi.
  • Depart from San Francisco International Airport, CA
  • Take ramp left for US-101 South toward San Jose (2.5 mi.)
  • At exit 419B, take ramp right and follow signs for Broadway (0.2 mi.)
  • Turn left onto Broadway (0.2 mi.)
  • Turn right onto Old Bayshore Hwy / Bayshore Hwy (0.1 mi.)
  • Turn left onto Airport Blvd (0.7 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)
Directions from San Jose International Airport, CA: 31.1 mi.
  • Depart Airport Blvd toward Airport Blvd (1.0 mi.)
  • Bear left toward Skyport Dr (0.3 mi.)
  • Keep straight onto Skyport Dr (0.1 mi.)
  • Take ramp left for CA-87 N / Guadalupe Pkwy (0.7 mi.)
  • At exit 9B, take ramp left for US-101 North toward San Francisco (28.6 mi.)
  • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
  • Keep straight onto Anza Blvd (0.2 mi.)
  • Turn right onto Airport Blvd (0.0 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)
  • Directions from Metropolitan Oakland International: 27.5 mi.
    • Depart Airport Dr toward Airport Dr (0.3 mi.)
    • Turn right onto Alan Shepard Way (0.0 mi.)
    • Turn right onto John Glenn Dr (0.5 mi.)
    • Turn right onto Ron Cowan Pkwy (0.0 mi.)
    • Take ramp left for Airport Dr (0.7 mi.)
    • Turn right onto CA-61 / Doolittle Dr (0.9 mi.)
    • Keep left to stay on CA-61 / CA-112 / Davis St (0.5 mi.)
    • Take ramp right for I-880 South toward San Jose (6.7 mi.)
    • At exit 27, take ramp right for CA-92 West toward San Mateo Br (13.1 mi.)
    • At exit 13B, take ramp right for US-101 toward San Jose / San Francisco (4.1 mi.)
    • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
    • Keep straight onto Anza Blvd (0.2 mi.)
    • Turn right onto Airport Blvd (0.0 mi.)
    • Arrive at Airport Blvd on the right (0.0 mi.)
    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.
    Location 2:
    Philadelphia, PA (Venue to be announced shortly)

    May 31 - June 1, 2018
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    Seminar One Registration

    March 22-23, 2018, San Francisco, CA


    Seminar One Registration

    May 31 - June 1, 2018, Philadelphia, PA

    Early bird seats are limited and based on first-come, first-serve.

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    Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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    Speaker is very knowledgeable. Glimpses "behind the curtain" in to the FDA are quite valuable in my opinion. GRC Seminars has a broad catalog of professional advancement opportunities.
    - Manager, Quality Control, 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 GRC Seminars was easy. Details of the course content were helpful. There was quick communication of required materials from GRC Seminars after the registration.
    - Quality Assurance Coordinator, Procter & Gamble

    Speaker was informative. Contract laboratories topic was most valuable to me. Location was great. GRC Seminars staff was excellent in resolving the registration issues with hotel.
    - Research & Development, 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. GRC Seminars is very good at communicating and working with me.
    - Quality & Safety Compliance Manager, 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.
    - Research & Development, Estée Lauder Companies

    Overall it was good seminar. GRC Seminars was very good at email communication prior to the seminar.
    - Quality Control Supervisor, 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 GRC Seminars 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

    The instructor had so much experience and gave lot of examples that make the information easy to understand.
    - Scientist I, ViaCyte, Inc

    I 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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    Think Escape Party Bus
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    Philadelphia Museum of Art
    The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. A large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.

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