關於 quality control and quality assurance ，我們在網路上蒐集到這些相關的討論、資訊與評價

Can I say, QA is for sake of Reputation?

SEPARATION ANXIETY | I’ve been working late a lot this week which means Ella Grace has really been struggling w getting enough mama time.

***
What that looks like is:
More meltdowns than usual over very little seemingly insignificant things
Getting really jealous when I give anyone else attention
Refusing to go to bed and forcing herself to stay up as much as possible
Whining, crying as soon as she sees me
Making a lot more “defiant” choices

***
What she’s really trying to say is:
I miss you mama, when are you coming home? Have you forgotten me?
I miss you mama, when you give other people attention, I feel rejected.
I miss you mama, I haven’t had enough time w you.
I miss you mama, I put on my listening ears all day and tried very hard and now that you’re home, I feel safe to finally feel all the things I needed to feel because I know you’ll hold space for me.
I miss you mama, where did you go?
I miss you mama, I’m trying to stay up as late as I can to see if I can wait for you.
I miss you mama, I really need to empty my sad cup so I’m pushing the boundary so you’ll make safe supported space for me.

***
How it feels as a mama:
Guilty, so so very guilty 😭😭😭💔
Heartbroken because I know it’s not her fault and it’s so hard to navigate an adult working world with a child’s heart
Frustrated because I’m exhausted and really looking forward to come home to my usually joyful girl but who’s really struggling
Questioning all my career choices and why I even work and what is the point and can I quit and wah wah wah wah wah!!!!

***
How I respond as a specialist:
Pour into my empty cup : hold space for me to work through my emotions
Just like Ella Grace, I need to HALT - hungry, angry, lonely, tired so try to give me what I need so that I can give her the mama she needs.
Connect, connect, connect - make time to connect w her in the mornings before she goes to school and if I can, in the evenings too.
Hold boundaries - Allow freedom within our boundaries but don’t change them because I feel bad. Instead, more than ever, she needs the security and assurance of knowing what to expect. Eg. No changing rules, allowing things they usually aren’t allowed to do, change plans, etc.
PLAY - All little one’s love language is rooted in play whether it’s touch, gifts, words of affirmation, quality time or acts of service. Children don’t say “Will you love on me?”, instead they ask, “Will you play with me?”. Making time for child-led play together w no aim other than just to connect is incredibly healing to the relationship.

***
How to use the PLEASE tool to process her emotions:

PREPARE
Prepare her and let her know who, what, when, how, where, why of her schedule and people so it helps her understand, know what to expect, and feel more in control of the situation

LISTEN
Listen to her big feelings and small things. Take time to just sit with her and listen for what she is feeling, what her concerns might be, what she needs

EMPATHIZE
Really empathize without judgment or control. Trying to understand how she might be feeling and helping her identify all emotions behind her behavior (the iceberg!!!) with love instead of judgment.

ACKNOWLEDGE
Echoing how she feels even if it’s “wrong” or “irrational”. She needs to be heard not corrected or fixed. She’s operating from a hurt place, she wants to feel safe and validated and only empathy can really help her feel less threatened to help her move to her rational/logical brain.

SIT
Allow her to feel, tantrum, hurt, cry, scream, or feel whatever she needs to feel. It’s their way of expressing the things they need to express when they don’t have words. Create safe supported space for her to do so - the only rule is that I keep her physically safe from herself, others, and the environment, blocking her, holding her hands, giving her privacy away from others if it’s a public space. I stay with her with as much space as she needs. (This is honestly the hardest part as a mama, to just sit w her, stay calm and confident, echoing and empathizing, “doing nothing” but just trusting her.

EMPOWER
When she finally moves closer and is ready for connection and reasoning, that’s only when we have a conversation. We help problem-solve and lead her to find a way to feel empowered in the situation. What can you do when you miss mama? Who can you look for? What can you say? What would you like to do when I come home? What do you want to eat/play/read/etc when I’m gone? Let them lead this conversation, she may only be upset about one thing or she might want to go down the list. It’s completely up to her because it’s whatever she needs to feel like she is seen and heard and safe.

When she was younger, this was one or two really simple things, as she gets older and is able to verbalize more, it’s incredibly powerful and reassuring to watch her be able to take ownership on her own.

That’s really the heart of why I do what I do and teach what I teach. It’s leading with love and giving our little ones a voice and the independence to grow and know that they are loved, trusted, believed in beyond measure, whole, able, and competent.

What are some of your questions?

***
Racheal Kwacz is a Child and Family Development Specialist, women’s leadership speaker and mama tribe advocate. As creator of the ‘RACHEAL Method’, she combines her 20+ years experience working with children in the USA and in Asia with the foundations of ‘Respectful Parenting’, leading parents and teachers around the world to raise kind, confident, compassionate, resilient little ones.

To learn more, follow and connect with her on ig and fb @rachealkwacz !

***
Ps. This beautiful photo is courtesy of the incredibly talented Erica Knect from That Wild Road. I highly recommend her if you’re looking for gorgeous, in-the-moment, heart-felt family photography.

👍把握最後報名 課程即將額滿~

~2019/07/27 (六)【臨床試驗系列】-臨床試驗成員角色、計劃書設計與試驗執行及監測實務(進階課程)

#臨床試驗計劃書設計 #試驗設計考量 #臨床試驗SIV #臨床試ㄐ驗執行與監測實務 #臨床試驗成員角色RolePlay

👍立即線上報名，好課程不錯過!!
https://slbiotech.pse.is/J9PU6

主辦單位：台灣光鹽生物科技學苑
課程地點：光鹽會議中心
課程地址：台北市復興北路369號7樓
課程日期：108年07月27日 (六) 09:00至17:00
授課師資：台灣生醫品質保證協會 陳品汝理事
學員對象：
(1)對臨床試驗相關工作者有興趣者
(如PI,PM,RA,RD,MA,DM,ST,CRA,CRC,QC,QA,MW等…)
(2)曾參與本學苑或其他新藥/臨床試驗課程的學員
(3)生技公司/新藥公司/藥廠或CRO現職人員

【授課大綱】

一、概述新藥開發與GxP
二、臨床試驗的成員架構與角色
三、臨床試驗委外後，試驗委託者(sponsor)的角色
四、試驗設計與試驗計劃書的形成
(1)試驗案件的成立
(2)試驗設計考量
-Regulatory requirements
-Study phases & Study type
-Selection of control group & Treatment scheme
-Binding design
-Study endpoints
-Subject population
-Number of subjects and clinical sites
(3)試驗計劃書的形成
-Life cycle
-Structure of Protocol (protocol template and examples)

五、試驗案件的準備、起始、監測
(1)試驗案件的準備
-Trial master file build-up
-Site selection & Vendor selection
-IP labeling/packaging
-FDA & IRB submission
-Investigator meeting
-Project management plan (PMP)
-Monitoring visit plan (MVP)
(2)試驗案件的起始
-SIV前準備
-SIV的執行
-SIV後的後續作業
(3)試驗案件的監測
-試驗監測計畫
-試驗監測前準備
-試驗監測的執行
-試驗監測後的後續作業

六、分組演練: 臨床試驗Role Play

*本課程包含分組討論及演練

課程費用：每人2,500元；

*上課達滿時數六小時，並完成案例演練者，核發本課程結業證書

【師資介紹】

陳品汝

現職：
台灣生醫品質保證協會 理事
美國品保協會 註冊之GCP品保專業人員
(Society of Quality Assurance, Registered Quality Assurance Professionals in GCP)

經歷：
佳正國際股份有限公司 品保經理
佳生科技顧問股份有限公司 資深品保稽核員
佳生科技顧問股份有限公司 專案經理
佳生科技顧問股份有限公司 臨床研究專員
美國臨床研究專業學會 認證之臨床研究專員
(Association of Clinical Research Professionals, Certified Clinical Research Associate)

若本梯次無法前來，可填寫預約報名連結：https://goo.gl/forms/rS6eeRbuMrRXMILw1

【溫馨提醒】

本學苑採用線上繳費系統，請注意下列重要事項：

1.請學員報名務必先填寫Google報名表單後，再進入線上繳費系統。
2.本線上系統有下列兩種繳費方式
(1)信用卡繳費-需輸入卡號、有效月/年、卡片背面末三碼、手機驗證
(2)ATM櫃員機-產生虛擬帳號，由ATM轉帳
3.因繳費系統產生之帳單三日後即失效，敬請特別留意，如有任何問題，請來信或來電與學苑聯絡。
4.公司團體(三人以上)報名作業，如無法於本系統作業者，再來信或來電本學苑洽詢。

學苑信箱：bioschool@biotech-edu.com 學苑電話：02-2545-9721

小額贊助安撫蒟嫂 https://p.ecpay.com.tw/E2494

待了半輩子的辦公室，叫了半輩子的GM、RD、QAQC
到底是蝦咪挖糕？
本單元讓你知道這些常見的辦公室簡稱
真正的意思是什麼

本單元出現單字

OL/ office lady
Business girl
簡稱/ Abbreviation
R&D /RD /研發/ Research and development
GM / General Manager / 總經理
Assistant manager / 特助 / AGM / AM
Materials Manager 資材部經理 簡稱 MM
Regional Manager / 區經理 / RGM
Purchasing Manager / 採購部經理 / PM
Sales Manager / 業務部經理 / SM
Vice President/ 副總/ 副總統/ VP
公關/ Public Relations / PR
品質/ Quality
QA/ Quality Assurance / 品質保證
QC / Quality Control / 品質管控
人事部/ Human Resource / HR
人力/ Manpower
CEO / Chief executive officer / 執行長
COO / Chief operating officer / 營運長
CFO / Chief financial officer / 財務長
CMO / Chief marketing officer 行銷長
HQ / 總部/ Headquarters
分公司/ Branch office
母公司/ Parent company
子公司/ Subsidiary
FNG 新進人員/ Fucking New Guy
新手/ Rookie

蒟蒻學英文系列影片~

學英文到底有什麼用https://youtu.be/I83UIuX0wDs
辦公室職稱英文https://youtu.be/ELUIWZbygQ4
臉部英文大解析https://youtu.be/BCEwQgNtJLE
電影明星的英文念法https://youtu.be/pi06knRMkuI
跟數字有關的英文https://youtu.be/1K6LJdiIGjc
美國有幾個時區https://youtu.be/hZsZvlSRbCs
這些女鞋的英文怎麼說https://youtu.be/c5PI5lOmERM
跟天災有關的英文https://youtu.be/tz9hQADAkXo
跟身體有關的英文https://youtu.be/oX-rlkmpvCk
婚禮誓詞的英文https://youtu.be/VdHqMm7jnik
跟狗狗有關的英文https://youtu.be/O6_aDwO4Zho
跟廚房有關的英文https://youtu.be/QVtprVv1NjU
跟電玩有關的英文https://youtu.be/h3oFg8KpLVg
跟雞雞有關的英文https://youtu.be/Q6iOZQChkQw
跟妹妹有關的英文https://youtu.be/f_eLuPU2BhU
跟死亡有關的英文https://youtu.be/nFIt6B6SooQ
跟槍械有關的英文https://youtu.be/uPJP3PX_9n0
如何跟外國人聊天https://youtu.be/wBwVFrDXmb4
跟棒球有關的英文https://youtu.be/BD3wAN56fOM
軍事英文唸法https://youtu.be/3mmdlySlOXQ
亞洲國家的英文https://youtu.be/CZaAywriF-E
歐洲國家的英文https://youtu.be/BVoe1bcqBWM
美洲國家的英文https://youtu.be/-N0OP7AI0a0
非洲國家的英文https://youtu.be/hbxFB5JLPxk
大洋洲國家的英文https://youtu.be/hW1uHKOyjf0
如何利用部位來搜A片https://youtu.be/lbwRlnpKg3g
各種性愛體位的英文https://youtu.be/3fgVnczCIYY
有碼無碼的英文https://youtu.be/KWYqyRAYnNE
SM和多P的英文https://youtu.be/3GRktd9_-T4
有關地標的英文https://youtu.be/yvUCuRvk7qU
有關星座的英文https://youtu.be/S2d1ZkuS3cc
有關姿勢的英文https://youtu.be/Y2XZphod3FA
那些年我們聽過的電影歌曲https://youtu.be/PYZWlkZJB70
2018年梗圖繞口令https://youtu.be/CKos1k7YxAA
跟名人偉人有關的英文https://youtu.be/k7bPK3TzS64
跟發明有關的英文https://youtu.be/1w79AZjDNlc
大聯盟有幾支球隊https://youtu.be/Nuxh_3VgtQY

蒟蒻學歷史系列影片~

國務卿是什麼東西https://youtu.be/biyoj7f1ad8
美國的菸酒文化https://youtu.be/94hycBUDGn4
種族歧視背後的真相https://youtu.be/dpBo7NC1QDc
美國名字裡的秘密https://youtu.be/OqQzFJ_prvE
大家都誤解的美國歷史https://youtu.be/Z_Vc26-ao9g
感恩節的由來https://youtu.be/QkHq3_kfeag
可以合法嫖妓的地方https://youtu.be/13b4DcKmiTA
南北內戰的由來https://youtu.be/O4SwEfwSJy4
美國文化冷知識https://youtu.be/9F55jLPex_E

蒟蒻碎碎念系列影片~

何謂薪資透明化運動https://youtu.be/kFveqhy1qgw
為什麼左撇子比較聰明https://youtu.be/M0SVWeXH6Rw
黑人為什麼那麼笨https://youtu.be/UQ-Lsi4YoeU
台灣有多少外國人https://youtu.be/W6vOy993DM0
誰跟你說我種族歧視https://youtu.be/bYp2ibXQ97U
古代人為什麼那麼醜https://youtu.be/TK5151v5soY
川普沒有你想的那麼笨https://youtu.be/ThE1dveZd0I
黑人白人犯罪率大車拚https://youtu.be/ZYNhLOLoimA
5分鐘讓你了解摩門教 https://youtu.be/fOqeKKJP1nM

蒟蒻聊感情系列影片~

如何找適合你的伴侶https://youtu.be/kDfshMFsoQ4
如何搞一夜情https://youtu.be/lQBiOZ7X2eU
如何讓他丟掉前女友的遺物https://youtu.be/PL0P9ns-Gkg
為什麼男人該去結紮https://youtu.be/KsdNS2oTm10
為什麼愛情有兩年魔咒https://youtu.be/qX0rX2ir0A0
老外在台灣怎麼把妹https://youtu.be/4Os-FXhBgJc
為什麼美女反而容易晚婚https://youtu.be/-7OF_NzU1QY
老外的審美標準在哪裡https://youtu.be/bQlkC9Aa7eg
什麼樣的男人會家暴https://youtu.be/8pzqnQq_8IE
如何挑選適合的男朋友 https://youtu.be/Fd9bua8DWVg