衛生署技術與營運管理人才培育計畫
『生技製藥cGMP認證學程』
生技醫藥品質技術及營運管理人才認證
國際同步接軌的專業課程研討與實習
國際級cGMP專家全程英文講授
課後討論中文翻譯
第一期培訓簡章
委辦單位： 行政院衛生署疾病管制局
承辦單位： 國家衛生研究院
University of Waterloo
PharmEng Learning Institute
課程諮詢： 037-246166 ext 33211施先生（jerome@nhri.org.tw）
037-246166ext 33207;劉先生（albertliu@nhri.org.tw）
0922-424088 蕭先生（fred.h@pharmeng.com）
網頁：http://incucbation.nhri.org.tw ; http://www.pharmeng.com
『cGMP生技製藥認證學程』
-邀請生技及製藥菁英與國際接軌-
近來全球各大藥廠及生技公司積極投入研發生技製藥之領域，台灣政府也大力的推動扶植；由於生技製藥產業具有高技術、高門檻及高利潤等特色，使得產品有較長的生命週期及相當豐厚的投資報酬率，為了要將研發的產品推向國際市場，就必須使產品之研發生產符合全球之相關規範。
cGMP為生技製藥產業國際化發展的要項之ㄧ。為讓生技醫藥產品行銷全球並培養與國際接軌的生技製藥cGMP專業人才，使具國際化生技製藥生產管理水準，行政院衛生署疾病管制局，國家衛生研究院「創新育成中心」與疫苗研發中心、University of Waterloo, School of Pharmacy (UW-SP)，PharmEng Learning Institute (PLI)共同設計課程，安排完整的訓練計畫。
本計畫由行政院衛生署疾病管制局補助，引進與國際同步cGMP訓練課程，全程cGMP專家英文授課，提供國外cGMP訓練的課程與環境，合格者授予國際認證證書，提昇專業價值機會難得，敬請把握。
時間：週五及週六全天（上午8:30~12:30，下午1:30~6:00），每單一課程計16小時
地點：國家衛生研究院南軟園區辦公室
(台北市115南港區園區街3號10樓)
特色：
ü 與國際接軌之最新cGMP訓練：國家衛生研究院、University of Waterloo-School of Pharmacy (UW-SP)、PharmEng Learning Institute (PLI)共同設計課程內容與安排講師群，提供最新國際cGMP實務課程。
ü cGMP種子師資之培訓：本訓練計畫目的在培訓cGMP專業人才，並為國內培養cGMP種子師資，有系統地培訓生技製藥相關業者，提升產業水準。
ü 將生技醫藥產品推上國際舞台：建置產品完整之文件系統，以符合FDA、ICH、EU、PIC/S (Pharmaceutical Inspection Cooperation Scheme) 等國際規範，以期將國產藥品推上國際舞台。
ü 循序漸進之學程規劃：三大核心課程、五大學習領域，完整課程規劃，引進國外成功推行之訓練模式，一次提供國內生技製藥業者最佳訓練方案。
ü 修習學程可獲國際認證：完成完整學程可獲頒國家衛生研究院、University of Waterloo-School of Pharmacy (UW-SP) 及PharmEng Learning Institute (PLI)聯合證書，為國內首見之cGMP國際認證課程。
ü 實習與理論之完美結合：國家衛生研究院「生物製劑先導工廠」中各類生產線完備、cGMP組織完整，能在產程規劃、設施施工管理、確效認證、生產管理、法規管理等方面提供學員最佳的研習場地，將課程理論與實務完美結合。
網頁：http://incucbation.nhri.org.tw
;
http://www.pharmeng.com
培訓對象：
l 目前從事或將來欲投入生技醫藥高科技產業之研發、製造與服務機構者
l 空調、水系統、建築設計等工程專業人士，欲參與生技製藥工廠建造者
l 政府、學研機構及法人單位與生技製藥產業發展及cGMP業務相關者
l 目前從事cGMP相關事務，欲進修相關專業知識者
l 品管、顧問等業務，欲積極進入生技製藥領域者
l 面對企業經營國際化之需求，須取得國際認證者
l 欲經由研習取得cGMP國際認證提升自我之菁英
師資：師資群由國際藥廠資深專家及PharmEng
專業顧問所組成，課程進行中安排有翻譯人員，詳細講師資料請至網站查詢。
收費：(含餐點)
|
報名方式 |
費用 |
|
選修單一課程 |
每人12000元 |
|
團報（5人以上）9折優惠，每人10800元 |
|
|
選滿12門課程優惠價 |
每人10萬元 |
|
團報（5人以上）9折優惠，每人9萬元 |
本期選滿12門課程者，可以最優惠學費參加後續培訓課程。
認證：
a. 選修單一課程合格者由PharmEng提供證書
b. 修滿12門課且合格者由NHRI、WP、PharmEng頒發初級證書
c. 修滿18門課且合格者由NHRI、WP、PharmEng頒發中級證書
d. 修滿24門課且合格並完成實習訓練課程者由NHRI、WP、PharmEng頒發高級證書
e. 本期學程提供12門課，完整修習且合格者可獲初級證書及實習訓練課程參加資格
主課程架構：
課程內容
|
編號 |
日期 |
講師 |
名稱 |
|
S-01 |
July 13 |
TBA |
1st cGMP Regulatory and Compliance Symposium (FDA focus) |
|
CP-01 |
July 14, 15 |
Pele Chong (NHRI) |
Biosafety Considerations and Good Laboratory Practices |
|
CP-02 |
July 21, 22 |
Jerry Holatko (PLI) |
Master Plan - Roadmap to Compliance |
|
CP-03 |
Aug 18, 19 |
Xuefeng Yu (sanofi) |
Project Management in a Biotechnology and Pharma Regulatory Environment |
|
CP-04 |
Aug. 25, 26 |
Xuefeng Yu (sanofi) |
Manufacturing Control in Pharma and Biopharma Industries |
|
CP-05 |
Sept 15, 16 |
Maja Mrkic (PLI) |
GMP Programs - Concepts, Planning and Implementation |
|
S-02 |
Sept. 21 |
TBA |
2st cGMP Regulatory and Compliance Symposium (PIC/S focus) |
|
CP-06 |
Sept. 22, 23 |
Maja Mrkic (PLI) |
Effective Quality Assurance: Audit Programs, Annual Review and CAPA |
|
CP-07 |
Oct. 13, 14 |
Craig Lee (Wyeth) |
Best Practices Implementation for Process and Cleaning Validation |
|
CP-08 |
Oct. 20, 21 |
Dr. Helen Mao (Merck) |
Risk Based Approach to Inspecting Quality Systems |
|
CP-9 |
Oct. 27, 28 |
Peter Doherty (PLI) Jake Thiessen(UofW) |
Analytical Methods Validation for FDA Compliance |
|
CP-10 |
Nov. 3, 4 |
Peter Doherty (PLI) |
Computerized Systems Validation Strategies |
|
S-03 |
Nov 23 |
TBA |
3rd cGMP Regulatory and Compliance Symposium (ICH focus) |
|
CP-11 |
Nov. 24, 25 |
Nader Moslemian (PLI) |
Commissioning and Validation of Pharma and Biotech. Facilities and Utility Systems |
|
CP-12 |
Dec. 1, 2 |
John Cobby (Galenos) |
Good Clinical Practices |
|
CP-2006 |
CP-01 ~ CP-12全修課程 |
||
講師簡介
Pele Chong, PhD, is Distinguished Investigator and Director at Vaccine Center for Research and Development, National Health Research Institutes (NHRI). He obtained his Doctorate in Biochemistry from University of Alberta He has an extensive experience with over 25 years in the biotechnology and biopharmaceutical research and industries, covering business development, product registration, project management, good manufacturing practices (GMP) facility management, finance, supervising skill, bioorganic synthesis, vaccine formulation and delivery technologies, protein purification and characterization, functional genomics. Pele has ever been the former of vice president and chief scientific officer of UBI and UBI Asia, corporate platform leader and research director at Aventis Pasteur.
Jack Basarke is Senior Director, Consulting Division, at PharmEng Technology Inc. He obtained his Bachelor of Science degree in Chemistry from York University, a Diploma in Public Health from Ryerson University and a Certificate on ISO Auditing from Academia Qualities. He is a former Head of the Drug GMP Unit of Therapeutic Products Directorate at Health Products and Food Branch Inspectorate, Health Canada. He joined Health Canada in 1970 and has been involved in all aspects of activities carried out by the division. He has made numerous presentations on GMP and related topics to industry professionals at the local, national and international level. He is one of the contributing authors of the book GMP Compliance, Productivity and Quality.
Jack Basarke is Senior Director, Consulting Division, at PharmEng Technology Inc. He obtained his Bachelor of Science degree in Chemistry from York University, a Diploma in Public Health from Ryerson University and a Certificate on ISO Auditing from Academia Qualities. He is a former Head of the Drug GMP Unit of Therapeutic Products Directorate at Health Products and Food Branch Inspectorate, Health Canada. He joined Health Canada in 1970 and has been involved in all aspects of activities carried out by the division. His contributed to the Mutual Recognition Agreement with the European Union, a "Quality Evaluation Exchange" program with the European Union & as an Operations Manager with OCMA, Drug Strategy and Controlled Substances Programme. He has made numerous presentations on GMP and related topics to industry professionals at the local, national and international level. He is one of the contributing authors of the book GMP Compliance, Productivity and Quality.
Jake Thiessen, PhD, is the Hallman Director, School of Pharmacy University of Waterloo, Waterloo, Ontario, Canada. Jake is a professor and former associate dean at the Leslie Dan Faculty of Pharmacy, University of Toronto. He earned his B.Sc. (Pharm) degree from the University of Manitoba, and went on to complete a M.Sc. at Manitoba and a Ph.D. at the University of California, San Francisco. Jake’s area of specialization is pharmacokinetics. His research interests include new approaches in cancer treatment and new molecules to treat patients with iron overload. He has broadened his experience and shared his expertise through work with the Drug Quality and Therapeutics Committee of the Ontario Ministry of Health, Health Canada’s Scientific Advisory Committee on Bioavailability and Bioequivalence, and the Canadian Council for Accreditation of Pharmacy Programs.
Shou-Bai Chao, PhD, Assistant Vice President, Wyeth Biotech, Wyeth Pharmaceutical, Collegeville, PA. He obtained his Doctorate in Biochemical Engineering from University of Waterloo, Ontario, Canada. Dr Chao has uccessful bio/pharmaceutical professional with extensive experience in biological product development and commercialization, manufacturing operations and quality assurance. Proven tracking record of managing global technical operations. Demonstrated ability to provide leadership and direction across diverse organization for maximum group performance. Expertise includes: facility design, commissioning, qualification and Start-up, BLA/CMC, submission, regulatory Inspections and Approval, quality and compliance management, qualification and validation, process and product development, technology transfer, contract manufacturing, organization development, leadership development. He is the former of senior manager of quality assurance, GENENTECH INC. South San Francisco, CA.
Craig Lee, PhD, is Associate Director, Wyeth Pharmaceuticals, Biotech Division. He obtained his Doctorate in chemical engineering from Syracuse University. He has the professional experience with over 20 years in biotechnology and manufacturing industries, covering facilities, equipments, cleaning, processes, documents, sterile filling and automations validation. Craig also has been the former project manager, engineering manager and engineering supervisor of biotechnology in Bayer Corporation, production specialist, general supervisor and senior chemical engineer of Bushy Park Plant in Bayer Corporation, and the senior scientist of Recra Environmental Inc.
Helen Mao, Ph.D., Chemical Engineering, is a pharmaceutical professional with extensive experience in GMP quality, compliance, process/product development, and technology transfer. After earning her Ph.D. degree in chemical engineering from the Chinese Academy of Sciences in Beijing, she worked as a post-doctoral fellow at the Industrial Biotechnology Center of the University of Waterloo, Canada. During the last 15 years, she has assumed various roles in industrial research, technical service, validation, quality and compliance at multinational companies including Albright & Wilson Americas, Apotex and Wyeth Pharmaceuticals.
John Cobby, founder of GALENOS, obtained his Doctorate in Pharmacy specializing in Pharmacokinetics and Bioavailability. John held various management positions in medical functions at three multinational healthcare organizations over 17 years, where he had responsibilities in clinical development and regulatory affairs. His experience also encompasses drug safety, medical information, review of promotional materials, and scientific support for marketing and sales functions. He was treasurer of the Medical R&D Section of Canada’s Research–Based Pharmaceutical Companies and served on various committees. He founded, and is an honorary lifetime member of, the Canadian Association of Professional Regulatory Affairs.
Jerry Holatko, B.Sc., Chem. is the Senior Director Medical Devices Division. Jerry has over 30 years experience in regulatory positions with Health Canada. His former position was Manager of Medical Devices / BTOX Unit in Ontario and Nunavut Operation Centre. He has extensive experience in regulatory development and interpretation, training, auditing, inspection and investigation of issues involving drugs and devices regulated under the Food and Drugs Act and Regulations. He was involved in the development and drafting of the current Medical Devices Regulations and associated guidance documents.
Peter Doherty, B.Sc. is a Senior GMP / Validation Consultant with PharmEng Technology Inc. He has over ten years of experience in the pharmaceutical and custom manufacturing industries, covering computer validation, stability, and quality control programs. His experience includes implementation of projects to ensure regulatory compliance of computer systems and laboratory standards. He has experience in the preparation and execution of IQ and OQ protocols for laboratory equipment, building monitoring systems and in-process control, and computerized systems. He is well versed with 21 CFR Part 11 compliance requirements.
Alan Kwong, P.Eng., M.Sc., M.B.A., is the CEO & Managing Director of PharmEng Technology Inc. He has an extensive background with over 20 years in the biotechnology and pharmaceutical industry and direct experience in all aspects of validation of facility systems, computerized systems, sterilization processes, dosage form products, biotech products and isolation technology. His expertise in the pharmaceutical industry includes: system integration and design of pharmaceutical and biotech facility, equipment and processes as well as feasibility studies, engineering, procurement, construction, project management, process optimization, production, quality assurance, validation, and current Good Manufacturing Practices (cGMP) compliance. He is an active member of ISPE, PDA, PEO, PSG, and ASQC.
Maja Mrkic, M. Sc. Chem, is Manger, GMP Compliance, at PharmEng Technology Inc. She has an extensive background in Quality Assurance, Audits, Master Validation planning, Drug Master File and Site Reference file preparation coupled with development and implementation of GMP programs. She has experience in different areas of validation/qualification: equipment, thermal processes, utilities, and retrospective validation of computerized system and legacy equipment to ensure compliance. She is well versed in GMP requirements (TPP/FDA/ICH/WHO guidelines) and compliance regulations for pharmaceuticals, biologicals, and active pharmaceutical ingredients.
Nader Moslemian, P.Eng, B.Sc. Mechanical Engineering, is the Director of Engineering & Metrology at PharmEng Technology Inc. He is highly experienced in preparing and executing installation, operation and performance/process qualification protocols for pharmaceutical systems. He has an in-depth knowledge of engineering and evaluation of facility and process expansion requirements for manufacturing and laboratory facilities. He is highly skilled and experienced in computerized design, calculation, operating cost and energy management analysis of building utility systems.
詳細講師介紹、課程資料與本學程即時訊息，敬請隨時參閱網頁公告
http://incucbation.nhri.org.tw ; http://www.pharmeng.com
主辦單位得視實際需要，保有課程、講員、時間變更之權利，不便之處敬請見諒
S-01、S-02、S-03為免費開放課程，邀請國內外專家學者以研討會形式進行。修習CP-2006（CP-01
~ CP-12全修課程）欲取得證書學員須全程參加。
CP-01 ~ CP-12為收費認證課程，每一課程講授16小時，參加學員須全程上課、完成作業繳交及通過考核，始得獲取該門課程證書。
修習CP-2006課程學員即為本學程永久學員，合格者可獲取本學程初級證書，並可享專業圖書借閱及本學程提供服務之權利。
課程諮詢：
037-246166 ext 33211施先生（jerome@nhri.org.tw）
037-246166ext 33207;劉先生（albertliu@nhri.org.tw）
0922-424088 蕭先生（fred.h@pharmeng.com）
繳費：
現金：請至國衛院竹南院區行政大樓出納室繳費
支票：支票抬頭請寫「財團法人國家衛生研究院」
匯款：匯款專戶- 台新銀行建北分行，帳號：00410070586700
戶名：財團法人國家衛生研究院
報名日期：開課前三天完成報名及繳費，以便寄送試題、作業與講義
報名：
傳真報名：037-583667
; e-mail報名：jerome@nhri.org.tw