Recordkeeping and Documentation in a GLP Laboratory (US FDA, US EPA and OSHA Focus)
Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.
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.
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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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 @ +1-888-771-6965 or email us @ customercare@fdatrainingalert.com
Payment:
Payment is required before 2 days of 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 from 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 FDATrainingAlert 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 FDATrainingAlert cancels the seminar, FDATrainingAlert 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.
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After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
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