ComplianceOnline

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 instructor Bill Schwemer is an ex-FDA official having more than 50 years of experience in dealing with FDA compliance matters that include 30 years he spent working with the FDA as a field Investigator, Director of Field Investigations, Assistant Associate Commissioner for Regulatory Affairs and Special Assistant to Deputy Commissioner for Policy.

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.
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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?
      • 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(8:30 AM - 1:00 PM)
  • 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
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.

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

Register Now

Online using Credit card

$999.00

Seminar One Registration

March 29-30, 2018, San Diego, CA
(Registrations till November 21, 2017 - $999)
(Registrations till January 25, 2018 - $1499)
(Registrations till February 20, 2018 - $1599)
(Registrations after February 20, 2018 - $1699)

$4,599.00
$5,994.00 (23%)*

Save $1,395.00

Special Group Discount Register for Six attendees

March 29-30, 2018, San Diego, CA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




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 +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

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 @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before 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 before 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 ComplianceOnline 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 ComplianceOnline cancels the seminar, ComplianceOnline 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 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location

San Diego, CA
(Venue to be announced shortly)

March 29-30, 2018

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

Testimonials

See What People Say About Us

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.

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

Quality Assurance Coordinator,

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.

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. ComplianceOnline 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. ComplianceOnline 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 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

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

We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

Media Partner:

Media Partner

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

Local Attractions of San Diego, CA

San Diego Cabrillo National Monument

San Diego Cabrillo National Monument

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line.

Sea Creatures at Birch Aquarium

Sea Creatures at Birch Aquarium

Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.

Legoland

Legoland

Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.

San Diego Zoo Safari Park

San Diego Zoo Safari Park

The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.

Coronado Island

Coronado Island

Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.

Balboa Park

Balboa Park

Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.

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

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