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

By:
Bill Schwemer, Principal, Schwemer Consulting and Former Senior FDA & Industry Official
Location 1:-
Tampa, FL

Thursday, March 3, 2016 | Friday, March 4, 2016
Location 2:-
Chicago, IL

Thursday, June 2, 2016 | Friday, June 3, 2016

Course "Quality Control Laboratory Compliance - cGMPs and GLPs" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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).

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




Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 1:00 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

  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

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 Online

$1,499.00

Seminar One Registration

March 3-4, 2016, Tampa, FL
(Registrations till February 5, 2016 - $1499)
(Registrations till February 15, 2016 - $1799)
(Registrations after February 15, 2016 - $1899)

$2,099.00

Seminar One Registration (With 2 Nights Stay)

March 3-4, 2016, Tampa, FL

$6,799.00
$8,994.00
You Save: $2,195.00 (24%)*

Special Group Discount Register for Six attendees

March 3-4, 2016, Tampa, FL
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left

$1,699.00

Seminar One Registration

June 2-3, 2016, Chicago, IL
(Registrations till February 5, 2016 - $1699)
(Registrations till February 15, 2016 - $1799)
(Registrations after February 15, 2016 - $1899)

$2,099.00

Seminar One Registration (With 2 Nights Stay)

June 2-3, 2016, Chicago, IL


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.

Register by P.O. / Check


Yes, I want to attend "Quality Control Laboratory Compliance - cGMPs and GLPs: One and a Half-day In-person Seminar".

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

Register by Wire Transfer




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 $200 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 ($200) 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.

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Testimonials

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

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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  • Article on the magazine and/or website after the conference.






Tampa, FL, Local Attractions

Chicago, IL, Local Attractions

More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.




Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.




Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.




Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.




Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.




At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.


One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.




The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.

Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!




With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.




You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.




A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.

Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.






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