Quality Control Laboratory Compliance - cGMPs and GLPs: One and a Half-day In-person Seminar
Bill Schwemer, Principal, Schwemer Consulting, Former Senior official with FDA's Office of the Commissioner
Tuesday, June 2, 2015 | Wednesday, June 3, 2015
San Francisco, CA
Tuesday, Aug 4, 2015 | Wednesday, Aug 5, 2015
Courtyard Boston Cambridge, MA
Tuesday, Nov 10, 2015 | Wednesday, Nov 11, 2015
||Course "Quality Control Laboratory Compliance - cGMPs and GLPs" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.
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.
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
|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
- Basics of FDA law and regulations for QC laboratories
- What is adulteration?
- Medical Devices
- What is CGMP?
- Medical Devices
- What is GLP?
- What is AIP?
- Contract Laboratories
- FDA inspection methodology
- Laboratory 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
- Analytical methods verification and validation
- Management and control of laboratory instruments
- Management and control of laboratory supplies
- Reagents, chemicals
- Proper conduct of laboratory investigations
- Out-of-specification results
- Out-of-norm results
- Root cause analysis
- Consequences of laboratory non-compliance
Meet Your Instructor
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.
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Chicago, IL(Venue to be announced shortly)
June 2-3, 2015
San Francisco, CA(Venue to be announced shortly)
August 4-5, 2015
Courtyard Boston Cambridge
777 Memorial Drive,
Cambridge, MA 02139, USA
November 10-11, 2015
Special Offer for the attendees of this seminar:
Rooms available at only $209 per night.
Call 866-323-4159 and identify yourself as part of the ComplianceOnline group
Please note: Hotel rooms are limited and based on availability
How to Reach
General Driving Directions:
From Boston Logan International Airport – BOS: 7.3 mile(s) W
From Manchester-Boston Regional Airport – MHT: 55.1 mile(s) SE
- Exit Airport and take MassPike (I-90) West to Exit 20 (Cambridge)
- Continue straight and cross bridge
- Take first right after bridge onto Memorial Drive
- Hotel is 200 yards ahead on the left.
From T F Green Airport – PVD: 62.1 mile(s) NE
- Follow I-293 to I-93S towards Boston
- Take exit 26B (Storrow Drive West) and continue for 3 miles
- Bear right at the Central Square/MassPike exit and turn right at the light
- After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
- Take I95N to I93N
- Then, take exit 26 (Storrow Drive West) and follow Storrow Drive
- Take the Central Square/MassPike exit and turn right at light
- After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
- South Station: 5 mile(s) SE
- B.U. Central (on the Green Line): 0.8 mile(s) SE
- Central Station (on the Red Line): 0.8 mile(s) NE
- Back Bay Station (BBY): 3 mile(s) SE
- South Station (BOS): 5 mile(s) SE
Disclaimer: Directions to the venue above have been taken from the hotel website. ComplianceOnline is not responsible for any inaccuracies in the same. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue.
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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Chicago, IL, Local Attractions
San Francisco, CA, Local Attractions
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.
Adler Planetarium and Astronomy Museum
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!
Arlington International Racecourse
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.
Art Institute of Chicago
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.
Auditorium Building and Theatre
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.
Think Escape Party Bus
San Francisco Bay Area
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. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.
Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.
Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.
Think Escape Casino Tour
San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity