Webinar Agenda Tuesday, August 13, :00 am - 12:30 pm PDT

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Susanna Short
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1 Western Region 2013 Training Webinars Welcome eqa Update? Sherita Webinar Agenda Tuesday, August 13, :00 am - 12:30 pm PDT Observations from the Field and Notebooks Becky, Stephen, Mika, Martin, Sherita FRD Wishlist for. SD, QA, WR Field Office

2 eqa Update SOPs, SOPs, SOPs Tammy is in the process of writing SOPs for the eqa system. Western Region contact person: Sherita Normington (530) SN

3 Western Region Targeted Trials Targeted Trials list on Western Region IR-4 website: TargetedTrials_2013.pdf Updated Aug. 5, 2013 SN

4 Western Region QA Contacts Martin Beran Office: (530) Cell: (530) Sherita Normington Office: (530) Cell: (916) MB

5 Western Region 2013 Training Webinars Tidbits and Reminders

6 Western Region 2013 Training Webinars Things you know Things you don t know Things you really oughta know

7 Remarkably Clear Documentation Sometimes less is more SF

8 SF

9 SF

10 Simulated Airblast Applications If you re using a Solo back-pack mist-blower, are you putting on the amount of test substance you think are? Check overage left in tank to see! SN/RS

11 Real-life scenario Hawaii Banana Trial Pass times (132.9 sec) and calibrated output (36.33 ml/sec) should have resulted in 4828 ml of tank mix applied with ~ 1200 ml left over But The actual amount left in the tank was 2570 ml, an ~ 30% under application SN/RS

12 Real-life scenario Hawaii s SOPs require that they measure the left-over tank mix. If Julie hadn t checked this volume no one would have known there was a problem. Moral of the story Check left-over tank mix to prove to yourself that you are applying what you say you are! SN/RS

13 SF Hall of Fame

14 SF Hall of Fame

15 How are they different? QC reviews QC Review vs. QA Audit Is data complete and accurate? QC Reviewers: Mika, Stephen, Kathy, Grace QA audits Regulatory Requirement GLP, protocol, SOP compliance Can the study be reconstructed? QA Officer RS/SN

Responses to QA Findings Data corrections or explanations requested by QA need to be in the raw data/field data book not just in responses Audit reports are not

16 Responses to QA Findings Data corrections or explanations requested by QA need to be in the raw data/field data book not just in responses Audit reports are not part of study raw data Study raw data needs to be complete record of study conduct Attach corrected pages to responses and refer to those pages in your responses SN

17 Test Substance Label What needs to be on your TS label? 1) Name/CAS (Chemical Abstract Service) Number or Code Number 2) Batch number 3) Expiration Date 4) Storage Conditions MB

18 Transport Containers SOP - allow use of secondary containers - covers how you will label the container - Follow your SOP MB

19 SF What s wrong with this label?

20 Test Substance Check the pantry before you start baking Make sure you have the proper test substance prior to the application!! Keep a running list/inventory so you know if you don t have the TS yet. RS

21 A well-written deviation Provides all the information needed for the Study Director to determine the impact on the study RS/MB/DC

22 Provide details RS/MB/DC Deviation Do s Actual number of fruit collected Didn t collect the required number of fruit How many were required? How many did you collect? Moisture percentage of hay, prunes or hops Actual weight of samples Didn t make sample weight Well, what was the weight? Number of days the application interval or PHI differed from the protocol Not just application interval too short

23 Deviations Some Protocols are extra specific about type of equipment Dial Settings Watering cycles Greenhouse conditions Know the limits of your equipment before starting the trial and discuss with Study Director during draft phase As QA, we will still ask for a Amendment or Deviation even if there is already an discussing this issue MB

24 Deviation Do s Representative Sample From the field not too big or too small but just right (representative) Too big - appropriate reduction at the field Too small Just because there is enough to analyze isn t the goal It still must be representative RS/MB/DC

25 Deviation Do s Commercially acceptable commodity Sample Phyto Plant disease Insects Weeds What s the crop look like, would you buy it? We have to live with the results Not commercially acceptable may affect the residues RS/MB/DC

26 RS/MB/DC Too small and would you eat these?

27 RS/MB/DC Too Big?

28 Deviation Do s Just do it If the protocol/sop wasn t followed YOU DON T need Permission Audit finding.to write a deviation Just do it. RS/MB/DC

29 Two lists: 1) Protocol Section ) Notebook Part 6 L 2 Protocol trumps notebook. Multiple Trial Differentiation Must follow protocol requirements. Many options in the notebook are not applicable in a particular protocol. May want to mark your notebook page to match protocol before you get started. Let s take a look at an example. RS/SN

30 2013 Protocol vs. Field Data Book Sections 1 and 2 are the same for both the protocol and field data book for this particular study. We ll look at the remaining sections to see the differences. Protocol PR # Penoxsulam & Oxyfluorfen/Stone Fruit Field Data Book

31 2013 Protocol vs. Field Data Book Protocol PR # Penoxsulam & Oxyfluorfen/Stone Fruit Field Data Book

32 Multiple Trial Differentiation Two lists: 1) Protocol Section ) Notebook Part 6 L 2 Protocol trumps notebook. Much simpler Proposed changes Let s take a look Protocol Notebook pages SN/RS

33 2014

34 Training Logs You can have a log which contains relevant training from say ~last 3-5 years SF Nice reference here, note Webinar titles, and note about viewing

35 Training Logs If your record is light w/in the last three years. Then beef if up If you re showing part of your training record Include a reference to where the other records reside SF

36 Employing Temporary Field Workers Training Records and CVs are not required for those not entering data into the Notebook. but A separate page should list their names, describe the impromptu training that was given, and identify the actions performed in the trial. Form provided on WR website resources page SF

37 SF

38 Phyto Data Take a picture send it to the SD Describe in notebook Some good examples of pictures Dan Groenendale Gina Koskela/Joe DeFrancesco David Ennes RS

40 Application made 3/23/12 Treated Treated Untreated Untreated

41 CA54 TRT 01 and 02 Test Plots on TRT 01 TRT 02

42 Why do a speed recheck? Takes minimal time Wrong gear Speed off Time and trial saved in the long run worth the effort RS

43 Adjuvant Mixing Instructions Did you use an adjuvant? Does the label include mixing instructions? (e.g. carrier, then pesticide, then adjuvant) If so, please follow the mixing order on the label Document in the notebook Memo to file Or note on Part 6G MPT

44 MPT Adjuvant Mixing Instructions

45 SF Droplet Size 11.4 (3D)

46 PPE For Your Safety Please read MSDS and Label Wear recommended PPE long sleeves and long pants or a Tyvek suit Keep a change of clothes in your facility or truck Wash application clothes separately Wear em: Even if it s Hot! MPT

47 Signed Protocol Letter Dates for GLP Master Schedule Signature commits to conducting trial in compliance with GLPs Signed and returned BEFORE you start the study Send revisions ( is good) if going to miss by 1 month or more (rule of thumb) Questions RS

Western Region 2014 Training Webinars

Western Region 2014 Training Webinars Webinar Agenda Monday, October 12, 2015 11:00 am - 12:30 pm PDT Wrapping It Up Overview of Notebook Completion Guest Speakers Thanks to FRD Participants: Julie Coughlin,