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\n\nGLP requires many t ypes of documents. The seminar covers both the general issues and many spe cifics that laboratories can receive a non-compliance on. These range from data recording to validation issues to training records to archiving of d ocuments.
\n\nAn auditor can find numerous common errors and many\, many others that are specific to a particular laboratory. This seminar wil l go through many of the compliance areas and point out some of both of th ese types. For those implementing GLP or striving to maintain certificatio n\, this course should point out many areas to examine that would lessen a n unsatisfactory audit.
\n\nMost of the focus on a laboratory&rsquo\ ;s compliance with Good Laboratory Practice (GLP) or with the analogous IS O 17025 is on items such as the Standard Operating Procedures (SOPs)\, tra ining\, quality assurance testing\, and the statistical assessment of perf ormance 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 f ocus on these\, other areas might be ignored &ndash\; the more mundane and simple areas\, such as recordkeeping and archiving\, basic laboratory ope rations\, and safety.
\n\nUpon completing this course\, participants should:
\n\nThis course is aimed at those working in laboratories that m ust comply with Good Laboratory Practice or ISO 17025\, especially those w hose results are to be reported to the US Food and Drug Administration (FD A)\, the US Environmental Protection Agency (EPA)\, and the US Occupationa l Safety and Health Administration (OSHA). The various roles:
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\n\nJohn C. Fetzer\, PhD\,
\nConsultant\, 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\, titri metry\, the use of ion-selective electrodes\, and physical properties of a queous solubility and octanol-water partition coefficient that complied wi th Good Laboratory practices. As part of his consulting and contracting wo rk he developed GLP-compliant methods for a biopharma startup and for a pe trochemical company. In all of these various efforts\, numerous SOPs were written\, as well as the prototype of a later-approved ASTM method. He sup ervised and managed a GLP compliant laboratory for over 10 years and helpe d maintain the documentation necessary for compliance.
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\n SUMMARY:Recordkeeping and Documentation in a GLP Laboratory (COM) BEGIN:VALARM ACTION:DISPLAY TRIGGER:-PT1H SUMMARY:Recordkeeping and Documentation in a GLP Laboratory (COM) END:VALARM END:VEVENT END:VCALENDAR