ComplianceOnline

GLP requires many types of documents. The seminar covers both the general issues and many specifics that laboratories can receive a non-compliance on. These range from data recording to validation issues to training records to archiving of documents.

An auditor can find numerous common errors and many, many others that are specific to a particular laboratory. This seminar will go through many of the compliance areas and point out some of both of these types. For those implementing GLP or striving to maintain certification, this course should point out many areas to examine that would lessen an unsatisfactory audit.

Most of the focus on a laboratory’s compliance with Good Laboratory Practice (GLP) or with the analogous ISO 17025 is on items such as the Standard Operating Procedures (SOPs), training, quality assurance testing, and the statistical assessment of performance and compliance. These, however, are not all that an auditor may delve into. These might the bulk of an audit, yet a laboratory may still fail an audit while doing well on all of these areas. Since laboratories focus on these, other areas might be ignored – the more mundane and simple areas, such as recordkeeping and archiving, basic laboratory operations, and safety.

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

Learning Objectives:

Upon completing this course, participants should:

  • Know the variety of common documentation within a compliant laboratory.
  • Understand the requirements for entering information into logbooks and also to know some of the ways that are not compliant.
  • Understand the importance of logbooks for: chemicals, instruments, calibration, maintenance and repair, calibrations, training and competence. Know the information suitable in each type.
  • Understand the requirements for recordkeeping and archiving.

Who will Benefit:

This course is aimed at those working in laboratories that must comply with Good Laboratory Practice or ISO 17025, especially those whose results are to be reported to the US Food and Drug Administration (FDA), the US Environmental Protection Agency (EPA), and the US Occupational Safety and Health Administration (OSHA). The various roles:

  • Managers and supervisors of the laboratory
  • Quality officers and internal auditors
  • Scientists and research associates
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Day 01(8:30 AM - 4:30 PM)
  • Registration Process - (8:30 am till 9:00 am)
  • Session 1 (90 Mins)
    • Recordkeeping and Archiving – Who, what, when, where, why, and how these are performed – an Overview.
  • Session 2 (90 Mins)
    • Who is responsible – what are the roles?
  • Session 3 (90 Mins)
    • What things must be recorded and archived?
    • Why is this important? The Role of Records and Documents in Compliance and Operations
  • Session 4 (90 Mins)
    • Where are specific things recorded and archived?
    • The How to keep records, the Logging System, Offsite versus Onsite Archiving.
Day 02(8:30 AM - 4:30 PM)
  • Session 5 (90 Mins)
    • Basic laboratory operations - Facilities maintenance records
    • Sample entrance and records, Sample handling and storage, Chain of custody
  • Session 6 (90 Mins)
    • Sample preparation records
    • Weighing, volumetric glassware, labeling
    • Sample solution handling and records
  • Session 7 (90 Mins)
    • Stability testing! Logbooks for preparation of standards, reagents, and buffers.
    • Instrument repair and maintenance logbooks, calibration logbooks
  • Session 8 (90 Mins)
    • Prevention through the Use of Control Charts, Nelson's Rules as a Statistical Basic for such Monitoring
    • Troubleshooting and Prevention Efforts
    • Safety as a Compliance Issue
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John C. Fetzer

John C. Fetzer, PhD,
Consultant, Fetzpahs Consulting

Dr. Fetzer has been a method-development analytical chemist for over 3 decades. In that role he developed new methods for GC, HPLC, fluorescence spectroscopy, titrimetry, the use of ion-selective electrodes, and physical properties of aqueous solubility and octanol-water partition coefficient that complied with Good Laboratory practices. As part of his consulting and contracting work he developed GLP-compliant methods for a biopharma startup and for a petrochemical company. In all of these various efforts, numerous SOPs were written, as well as the prototype of a later-approved ASTM method. He supervised and managed a GLP compliant laboratory for over 10 years and helped maintain the documentation necessary for compliance.

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Register Now

Online using Credit card

$1,299.00

Seminar One Registration

December 14-15, 2017, San Diego, CA
(For Registrations till September 25, 2017 - $1299)
(For Registrations till October 25, 2017 - $1499)
(For Registrations till November 20, 2017 - $1599)
(For Registrations after November 20, 2017 - $1699)

$5,999.00
$7,794.00 (23%)*

Save $1,795.00

Special Group Discount Register for Six attendees

December 14-15, 2017, 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.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

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Palo Alto, CA 94303
USA

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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)

December 14-15, 2017

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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:

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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.

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