Western Region 2013 Training Webinars

Webinar AgendaTuesday, August 13, 201311:00 am - 12:30 pm PDT

Welcome

eQA Update? – Sherita

Observations from the Field and Notebooks – Becky, Stephen, Mika, Martin, Sherita

FRD Wishlist for …. SD, QA, WR Field Office

eQA Update

Western Region contact person:Sherita Normington

smnormington@ucdavis.edu(530) 752-9493

SOPs, SOPs, SOPs• Tammy is in the process of writing SOPs for the eQA system.

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Western Region Targeted Trials

Targeted Trials list on Western Region IR-4 website: http://wrir4.ucdavis.edu/contacts/TargetedTrials_2013.pdf

Updated Aug. 5, 2013

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Western Region QA Contacts• Martin Beran

– mjberan@ucdavis.edu– Office: (530)754-8525 – Cell: (530)574-2115

• Sherita Normington– smnormington@ucdavis.edu– Office: (530)752-9493– Cell: (916) 838-1100

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Western Region 2013 Training Webinars

Tidbits

and

Reminders

Western Region 2013 Training Webinars

Things you know

Things you don’t know

Things you really oughta know

Remarkably Clear Documentation

Sometimes less is more…

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Simulated Airblast Applications

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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!

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

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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!

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Hall of Fame

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Hall of Fame

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QC Review vs. QA AuditHow are they different?

•QC reviews • 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

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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

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Test Substance Label

What needs to be on your TS label?

1) Name/CAS (Chemical Abstract Service) Number or Code Number

2) Batch number3) Expiration Date4) Storage Conditions

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Transport Containers

SOP - allow use of secondary containers

- covers how you will label the container

- Follow your SOP

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What’s wrong with this label?

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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.

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A well-written deviation

Provides all the information needed for the Study Director to determine the

impact on the study

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Deviation Do’s…

• Provide details• 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 shortRS/MB/DC

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 email discussing this issue

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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

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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

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Too small and would you eat these?

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Too Big?

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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….

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Multiple Trial Differentiation - 2013Two lists:1) Protocol – Section 11.42) Notebook – Part 6 L 2

Protocol trumps notebook.

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.

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Protocol PR # 10899 Penoxsulam &

Oxyfluorfen/Stone Fruit

Field Data Book

2013 Protocol vs. Field Data BookSections 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 # 10899 Penoxsulam &

Oxyfluorfen/Stone FruitField Data Book

2013 Protocol vs. Field Data Book

Multiple Trial Differentiation - 2014

Two lists:1) Protocol – Section 11.42) Notebook – Part 6 L 2

Protocol trumps notebook.

Much simpler Proposed changes Let’s take a look

Protocol Notebook pages

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Training Logs

You can have a log which contains relevant training from say ~last 3-5 years

Nice reference here, note Webinar titles, and note about viewingSF

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

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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• http://wrir4.ucdavis.edu/Resources/default.html

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Phyto Data

Take a picture send it to the SD Describe in notebook

Some good examples of picturesDan GroenendaleGina Koskela/Joe DeFrancescoDavid Ennes

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Treated Treated

Untreated

Application made 3/23/12

Untreated

10908.13-CA54 TRT 01 and 02 Test Plots on 7-8-13

TRT 01

TRT 02

Why do a speed recheck?

Takes minimal timeWrong gearSpeed off

Time and trial saved in the long run…worth the effort

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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

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Adjuvant Mixing Instructions

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Droplet Size 11.4 (3D)

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• Please read MSDS and Label• Wear recommended PPE

– long sleeves andlong 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!

PPE – For Your Safety

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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 (email is good) if going to miss

by 1 month or more (rule of thumb)• Questions

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