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
Bill Schwemer

Bill Schwemer
Principal, Schwemer Consulting and former Senior FDA & Industry Official

Bill Schwemer is an ex-FDA official having more than 50 years’ experience with FDA compliance matters. He has worked as an FDA field Investigator and Compliance Officer, been a senior official with FDA's Office of the Commissioner and was V-P of RA/QA at a Personal Care Products Company. Mr. Schwemer worked in all program areas, but has consulted primarily with pharmaceutical and personal care products companies.

He has published more than 125 articles and since becoming a consultant has successfully served as a regulatory compliance expert witness in 20 lawsuits.

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

Register Now

Online using Credit card

$1,599.00

Seminar One Registration

May 18-19, 2017, Philadelphia, PA
(Registrations till April 30, 2017 - $1599)
(Registrations after April 30, 2017 - $1699)

$1,999.00

Seminar One Registration (With 2 Nights Stay)

May 18-19, 2017, Philadelphia, PA

$7,399.00
$9,594.00 (22%)*

Save $2,195.00

Special Group Discount Register for Six attendees

May 18-19, 2017, Philadelphia, PA
*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 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us 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 :

Philadelphia, PA
(Venue to be announced shortly)

May 18-19, 2017

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
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If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

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Gold Partner
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  • Logo on name cards
  • A half page brochure advert
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Silver Partner
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  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
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  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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Philadelphia Museum of Art

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Valley Forge National Historical Park

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With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.
The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.

The Liberty Bell Center

The Liberty Bell Center

The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.

National Constitution Center

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The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”

The Franklin Institute

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An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.
Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.

The Barnes Foundation

The Barnes Foundation

The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.

The Rocky Statue

The Rocky Statue

One of Philadelphia’s most famous pieces of public art is a bigger-than-life boxer… literally. Originally created for Rocky III, the sculpture is now a real-life monument to a celluloid hero. The fictional Rocky Balboa of Sylvester Stallone’s Rocky movies was immortalized in bronze in 1980. After filming for the movie completed, Stallone donated the statue to the City of Philadelphia.

Franklin Square

Franklin Square

Franklin Square, one of Philadelphia’s five original public squares laid out by William Penn in his original plan for the city, has undergone a dramatic renovation. The park now boasts several family-friendly attractions, including a miniature golf course, classic carousel, burger joint, storytelling bench, picnic area and more.

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