即將結業【11月線上課程】維持高品質QA :從系統建構、聯結、溝通與應用 (全修班)

2023/11/04~12/09 (每周六) (09:30~12:30 / 13:30~16:30)

【雙證書班】維持高品質QA :從系統建構、聯結、溝通與應用 (全修班)

【QA系列】

【適合對象】藥品製造相關從業人員、有品保相關知能需求之從業人員、生技產業相關領域從業人員等。
【課程規劃專家及授課講師】張簡雅青博士 ( 前生達化學製藥總經理室協理&品質系統總監)
【上課方式】本梯次採用線上課程(Zoom系統)
【預計開課/時間】2023/11/4~12/9 (每周六) (09:30~12:30 / 13:30~16:30)
合計: 六週第六週上課至12:30 (總時數: 33小時)
【線上報名】 我要預約 <---- 請點選搶先預約報名享早鳥優惠價
【測驗時間】倒數第二堂課線上考試 (線上測驗: 答題時間40分鐘)
【課程大綱】(正式課綱將有異動, 於正式開放報名前公告, 此為預排表) 最後更新日期2023/08/24

11/4 上午Documentation program
- Define different types of documents created for routine practices
- How to manage and control the lifecycle of the associated documents
- Frequently asked questions
- 483 case study

11/4 下午Facility and equipment qualification and requalification program
- Define the practices associated with qualification and calibration program
- How to establish an efficient requalification program, composed of facilities, utilities and equipment
- Illustrate IQ/OQ/PQ documents with some equipment, including production and QC test equipment
- Frequently asked questions
- 483 case study

11/11 上午 Change management
- How to improvement the efficiency of change control program
- Explain the most recent PIC/S PI054-1, 2021 “How to evaluate and demonstrate the effectiveness of PQS in relation to Risk-based change management”
- Frequently asked questions
- 483 case study

11/11下午 Out-of-specification program
- Highlight the principles in MHRA OOS guideline
- Briefing of US FDA OOS guidance : Investigating OOS Test Results for Pharmaceutical product, May 2022
- Explain the procedure for chemical and Microbial OOS investigation
- Emphasize aspects in TR 88 : Microbial Data Deviation Investigations in the Pharmaceutical Industry
- 483 case study

11/18 上午 Deviation program
- Explain the essential factors for deviation program
- How to improve the efficacy and efficiency within deviation program
- Investigation toolbox
- Frequently asked questions
- 483 case study

11/18 下午 Stability program
- Highlight the paramount aspects derived from related ICH stability guidelines, including ICH Q1A, Q1B, Q1C, Q1D, Q1E, Q1F
- Frequently asked questions
- 483 case study

11/25 上午 Method validation and method verification
- Interpretation of method validation and method verification
- Implementation of microbial method suitability study
- Frequently asked questions
- 483 case study

11/25 下午 Non-sterile Environment monitoring
- Basic principles of Environment monitoring
- Point out the essences of USP 1115: Bioburden control of nonsterile drug substances and products
- Frequently asked questions
- 483 case study

12/2 上午 Sterile facility environment monitoring
- Sources of microbial contamination
- Emphasize the importance of USP 1116: Microbial control and monitoring of aseptic processing environments
- Frequently asked questions
- 483 case study

12/2 下午 Point-to-consider in Aseptic processing area
- Control of high-risk aseptic process
- Proper design of ISO 5 cleanroom
- Contamination control strategy
- 483 case study

<今日課後測驗> 期末考範圍:單元1~10 (線上測驗)

12/9 上午 (結業)Point-to-consider in Annex 1- CCS
- Highlight important aspects in ISPE Risk Mapp
- ICH Q9 toolkit
- CCS perspectives
- 483 case study 本日上課至中午12:30 (3小時) 只上半天課

【證書資格】雙證書資格及核發辦法，參考如下: (線上測驗)

【結業證書】須出席滿80%時數以上 (27小時)，紙本掛號郵寄
【測驗合格證書】為協助學員掌握關鍵知識、技術及內化應用，並驗證課程設計與學習之有效性，亦參照TTQS訓練品質系統及手冊、ADDIE課程設計之精神等，本梯次將統一辦理期末測驗，各主題單元須達:70分以上(滿分:100分)，題型由講師設計，並將於課程結業前一周上課安排測驗(16:30~17:30)，於訓後1個月內於學院官網將公告【測驗合格名單】並開始寄發測驗合格證書(紙本掛號郵寄)。證書效期:3年，發照單位:台灣生物產業發展協會，如無須取得本證書者當日可免參加考試。本考試無法補考，證書遺失或需補發工本費為:NT:500元，效期無法展延。
如有未詳盡事宜可來電洽詢。

【考試費用】參加本梯次考試者，考試及發證費用: 免費(學費已內含 )
【上課方式】本梯次採用線上課程(Zoom系統)
【預計開課/時間】2023/11/4~12/9 (每周六) (09:30~12:30 / 13:30~16:30)
合計: 六週第六週上課至12:30 (總時數: 33小時)
【線上報名】我要報名 <---- 請點選

【課程費用】

非團體會員NT$22,000
協會團體會員NT$ 19,800
10/1前線上預約, 可先享有報名早鳥優惠價 NT$ 18,800 (限額/限時)
同公司二人以上報名及繳費享有優惠價 NT$ 18,800
原本班年度舊生(回訓) 可享【好學優惠價】 NT$ 15,000(限額五人額滿為止!)
以上費用包含講義及證書費用
【諮詢專線】02-2783 6028 分機11或分機12 歡迎來電
(注意事項:以上課綱及開課日期/授課師資/場地..等; 本協會保有異動權，如有變動將會提前通知)