GLP, EPA, IR-4 & MORE INFORMATION SOURCES Prepared by: Kathryn Hackett-Fields & Jane Forder

ONE TEAM – HOW? Individual expertise –Facility –Systems –Staff What each of us brings to the task completes the “quality puzzle” “Quality and Integrity” are keywords in GLP research, and in life. Quality – what is it? Durable Few or no defects Worth the price paid Pride of ownership Integrity – the same? Proof of the quality –Exams –Certification –Does it work in practice?

You Have the Power! Good News: Plenty of information on the Internet Bad News: Really, too much information Today’s News: Take what you need but keep learning! –EPA –FDA –Shipping critical material –Quality issues Use the “need to know” as a chance to form stronger teams

Resources: EPA EPA –A lot more than GLP –Career development Other regulations –Safety Quick references Personal exposure –Regarding GLP… Advisories Preambles Q&A Comment, calling to exempt farm equipment & commercial glassware from calibration – ruling was based on “quality and integrity of the study.” Requires that “methods and records ensure” this. Cylinders, flasks do not require recalibration, but what = “integrity?”

Resources: GLP, QA All regulatory websites will provide info. FDA is helpful for electronic data and archival guidance: 21 CFR Part 11 CROMERR, 40 CFR Part 3, 10/13/05 Final EPA’s new Electronic Records, Reports –Society of QA shares the bulk of resources with members, versus general public. This is an opportunity for teamwork with your QA –Topic of the Month? Lunch and Learn sessions?

Future Plans A keyword-choice database for regulatory and other guidance via the IR-4 website. Continue the emphasis on teamwork Is it time for project or time management training? What are your plans for yourself? –Invest an hour a week at home –Invest an hour a week at work

Thank You! Jane has prepared a great handout to get you started. Remember – everybody holds a piece of the quality puzzle. Your best results in OUR best – enjoy the rest of your time in Phoenix!