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

By: Kelly Thomas, Vice President, Americas Quality Operations
Location :- SpringHill Suites by Marriott San Jose Airport, CA | Monday, November 18, 2019 | Tuesday, November 19, 2019

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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

Kelly Thomas
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.

Venue

Location :

SpringHill Suites by Marriott San Jose Airport
10 Skyport Drive,
San Jose, CA 95110, USA
Tel: +1-408-650-0590

November 18-19, 2019



How to Reach

General Driving Directions:

Driving Directions from San Francisco International Airport (SFO)
  • Take the ramp to US-101 S/Bayshore Fwy. Keep LEFT at the fork to merge onto US-101 S.
  • Travel 31.7 miles and take the CA-87/Guadalupe Pkwy exit.
  • Merge onto CA-87 S. Travel 0.2 miles and take the Skyport Dr exit.
  • Travel 0.3 miles and turn left onto Skyport Dr. The hotel will be on the right.
Driving Directions from Oakland International Airport (OAK)
  • Exit the airport via Airport Dr. Continue onto Bessie Coleman Dr which becomes 98th Ave.
  • Turn right to merge onto I-880 S to San Jose. Travel 31.1 miles
  • Take the N First St N exit toward Downtown, Turn right onto N 1st St.
  • Travel 0.6 miles and turn left onto Skyport Dr. Make a U-turn and the hotel will be on the right.

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. GRC Seminars is not responsible for any inaccuracies in the same.
Register Online

Register Online

$1,299

Seminar One Registration

November 18-19, 2019, San Jose, CA

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

The registration fee includes: the workshop; all related course materials; morning tea/coffee on both the days, lunch and afternoon tea/coffee on day one.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

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If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965

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Yes, I want to attend "Quality Control Laboratory Compliance - cGMPs and GLPs: One and a Half-day In-person Seminar"
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Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2479 East Bayshore Road, Suite 260
Palo Alto, CA 94303
USA

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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ editor@grcseminars.com

Payment:

Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

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 $300 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 seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

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.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:

After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Testimonials

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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  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions of San Jose, CA

Bowlmor Lanes Cupertino
Located in the heart of Cupertino, Bowlmor Lanes Cupertino is a hip attraction where crowds can get more than the average night out. Bowlmor Lanes Cupertino features 32 lanes of glow-in-the-dark bowling, video screens on the walls, a top-notch sound system, a full sports bar and a billiards room. There is also a restaurant that serves up tasty fare lane-side so hungry guests don't have to abandon their game.

Campbell Historical Museum
The Campbell Historical Museum and Ainsley House may have been procured from the city of San Jose by Campbell, but this adorable English Tudor is still the perfect visiting stop for anyone in the county looking for a plush little getaway from modern times. The iconic English Tudor is elegantly restored and filled with many of the Ainsley's original furnishings (the couple built the house in 1925 to resemble the cottages of their native Britain). Bring a folding chair and a picnic basket for a series of free outdoor concerts every Thursday evening. Just because the setting is classic doesn't mean you can't engage in some modern fun.

Campo di Bocce
Just outside of the San Jose city limits, Campo di Bocce is a unique venue that remains a favorite San Jose attraction. With a full restaurant offering delicious Italian cuisine, a bar doling out everything from sodas to cocktails, and several bocce courts where everyone from family to friends to co-workers can try their hand at bocce ball and engage in light competition or just a fun and casual game.


Children's Discovery Museum
Serving the needs of children, families, and schools as a center for learning and discovery, this museum in downtown San Jose features interactive hands-on exhibits, programs, puzzles, games, classes and much more.

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