Glp epa ir 4 more
This presentation is the property of its rightful owner.
Sponsored Links
1 / 7

GLP, EPA, IR-4 & MORE PowerPoint PPT Presentation


  • 81 Views
  • Uploaded on
  • Presentation posted in: General

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

Download Presentation

GLP, EPA, IR-4 & MORE

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Glp epa ir 4 more

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?

ONE TEAM – HOW?


You have the power

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

8-17-1989 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: EPA


Resources glp qa

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

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

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!


  • Login