Orange G: 102 B: 0. NAICC Annual Meeting St. Louis, MO Author, Date (Arial, Bold, 24) 1. NAICC Annual Meeting St.

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1 Orange Pollinator R: 204 Studies Key Presentation title Points (Arial, for Bold, Auditors 32) G: 102 B: 0 NAICC Annual Meeting St. Louis, MO 2017 Author, Date (Arial, Bold, 24) 1

2 Acknowledgements Anna Kang ASK GLP Consulting Mary Kay Erickson MK Consulting 2

3 Overview Pre-inspection Document Review Critical Phase Inspections Test system set up Application (or treated seed planting) Sampling Common Findings Conclusions / Suggested Solutions Questions 3

4 Prior to Inspection Request documents and records Protocol and approved changes Relevant SOPs and/or procedural descriptions Plot diagram Test system history and maintenance records (crop AND bee) CVs and training records of relevant personnel Test substance or treated seed logs and records 4

5 Prior to Inspection QA should assure that: The protocol, SOPs and/or procedural descriptions are approved and provide adequate descriptions and sufficient detail to perform the activities. All personnel involved in the conduct of the study have documented training and/or experience to perform the activities. 5

6 Prior to Inspection Special Considerations The plot diagram and test system are compliant with the protocol requirements. Particularly any restrictions or considerations. Is the selected crop, variety, and plot size likely to produce adequate sample sizes? Navel oranges / pollen Soybean flowers / size of the plot Do the history and maintenance of the test system have any conflicts with any protocol restrictions? If the crop seed (not TS) is treated, is the label available and are there any conflicts with protocol restrictions. 6

7 Test System Set Up When treated seed is the test substance, QA should assure that: Equipment is cleaned and calibrated per SOPs Control plot is planted first Seeding rate, row spacing, and planting date is recorded Amount of seed planted is recorded Plot diagram accurately reflects plot layout and includes all details Dimensions, buffers, permanent markers, slope, etc. 7

8 Test System Set Up Special Considerations Hive placement Tunnel size and mesh size Bee maintenance (food, water) documented Bees appear to be appropriately active / healthy 8

9 Application Verify all calculations by independent means Test Substance, Reference Substance, tank mix Adjuvants Calibrations Pass times Verify proper tank mixing Watch nozzle output during application for uniformity Observe the disposal of excess spray mix 9

10 Applications Special Considerations Protocol may require application of water to the control plot Why? Stock solutions Check your pressure frequently! Assure that all requirements for the hives (placement, time of day, covered, etc.) are in compliance Assure that the water source provided for the bees is removed from the tunnel BEFORE application and that fresh water is provided AFTER application to avoid contamination. 10

11 Sampling SOPs or written procedures Balances Equipment Centrifuges Micropipettes and tips Filter vacuums Pollen extractors Probes and forceps Containers Properly labeled Correct per protocol (amber glass, falcon tubes, double bagged, etc.) 11

12 Sampling Field storage as per protocol (dry ice, blue ice, ambient) Time from sampling to storage documented and within protocol allowed limits Changes to the sampling method or problems in obtaining sample size should be communicated to the study director immediately Duplicate samples VS Analytical/Retain samples 12

13 Sampling 13

14 Common Findings Insufficient study personnel Personnel not adequately trained or training not documented PFI or PBI changes methods and procedures or plot layout without prior approval of the Study Director Sampling dates are changed outside protocol requirements without prior approval of the Study Director 14

15 Common Findings SOPs not in place for sampling procedures and raw data insufficient to reconstruct study activities Forms Inadequate or poorly designed Lack of communication between SD, PFI, and PBI Improper storage of samples in the field Small and delicate samples thaw faster and/or subject to necrosis 15

16 Suggested Solutions PBI or beekeeper input before finalizing the protocol Forms!!! Personnel and Training Two critical phase inspections, minimum If possible, depending on the size of the trial, having more than one auditor in the field at each inspection. 16

17 Orange R: 204 G: 102 Presentation title (Arial, Bold, 32) Author, Date (Arial, Bold, 24) 17 B: 0 Thank you for your attention