Provide Total Solutions for Viable and Non-viable Monitoring

美國PMS公司台灣分公司詳情請上網： http://www.pmeasuring.com請聯絡我們：03-5525300 新竹辦事處、06-5839169 台南辦事處或來信諮詢： E-mail：slin@pmeasuring.com聯絡人：林曉聖 (0905306017)

Provide Total Solutions for Sterility Assurance by QbD

隨著民眾對於健康的關注，呼籲全球製藥行業充分重視製藥生產的風險，並採取相關的風險控

制措施，已提高藥品品質。各國的法規主管機構及時更新了製藥生產監控的法規，歐盟GMP附

錄 1 (PIC/S GMP refer it)於2017年底發表修改草案，特別是對於數據完整性以及無菌製藥環境監

測風險評估提出了更新的要求。您是否瞭解了呢？是否在您的環境監測方案中做了充分準備？

面臨全球的審查官的檢查，你是否已經做好所有準備？

在此次研討會中我們將為您解讀EU-GMP Annex 1法規草案，以及對於環境監測的影響和數據完

整性要求。同時，我們還將從GMP, FDA, PIC/s, ISO 14698, ISO 8573等法規角度，配合國際上的實

際檢查案例，深入地解讀在新形勢下真正恰當的製藥行業之環境監測技術與策略。

Seminar Topics:

1. 新版EU-GMP Annex 1與舊版的差異?

2. 我們該如何審視現在的環境監測策略符合新版EU-GMP Annex 1?

3. 該如何進行風險分析，了解製程中的風險，來建立完整環境監測策略?

4.稽核單位為什麼如此重視數據完整性合規?

5. 如何進行滿足數據完整性之環境監測計畫?

6. 環境監測數據這麼多，我們該如何進行數據報告和趨勢分析?

7.為什麼微粒子或微生物採樣偶爾發現一些莫名的數值，沒有重複性，調查無結果？

8. 為什麼環境微粒子或微生物採樣沒有任何資料，但無菌檢查卻發現微生物？

9. 如何利用微生物和微粒子數據找到微汙染來源?

10. 如何降低產品汙染風險?提高藥品品質?

11. 實際案例分享。

EU GMP Annex 1 Insights and Updates & Best practice sharing：how a Data Integrity compliance system helps on the root cause identification?

Provide Total Solutions for Viable and Non-viable MonitoringProvide Total Solutions for Sterility Assurance by QbD

MR. Maurizio Della PietraGlobal Data Management Specialist and ProcessAdvisorPARTICLE MEASURING SYSTEMSMaurizio Della Pietra has experience in pharmaceutical validation and sterility assurance.He earned his Master's Degree in Physics with a thesis regarding an electronic trigger formeasuring of Supernova neutrinos for an international experiment. His experience in thepharmaceutical field started in 2006 in a consultancy company as computer system validation andcompliance specialist. From 2009 to 2017 he worked as Validation and Sterility AssuranceManager for a pharmaceutical company that produces freeze-dried and liquid sterile drug productsderived from human plasma. During these years, he improved his knowledge about QA processes,validation of equipment, utilities, facilities, computer systems, data and production processes andabove all he gained the experience about aseptic production processes and statistical analysis ofthem. Today Maurizio is the Global Data Management Specialist and Process Advisor for ParticleMeasuring Systems. In this role, he collaborates and consults with pharmaceutical companies andwith developers of pharmaceutical equipment and isolation technologies for improving thesterility assurance on science-based strategies.

Speaker Profile

MS. CHRIS WANGAsia GMP ExpertPARTICLE MEASURING SYSTEMSResponsible for the business development of PMS in China Life Science Industry, supporting Asiasubsidiaries on regulation compliance. Chris has more than 10 years Pharmaceutical environmentmonitoring and certification experience, specialized in the risk assessment and complianceconsultant. From 2012 to now, Responsible for the business development of PMS China LS Industry,being charge of the sterility assurance full circle solution service. In 2012, Chris have ever beeninvolved in the design and validation of the first unit of Real-time microbial site inspection forChina local FDA. From 2008 to 2012, PMS East China Sales man-ager. Have been involved in thedesign and constructions of hundreds of facility monitoring systems for sterile drug manufactories.Have ever trained the environmental monitoring regulations and applications for Shanghai FDA,Anhui FDA and some designing institutes. From 2004 to 2008, Chris has been in charge of cleanroom consultant service in China pharmaceutical and electronic industries and has ever providedthe risk assessment for Roche China, GE healthcare and some other Pharm. Companies.

Provide Total Solutions for Viable and Non-viable MonitoringProvide Total Solutions for Sterility Assurance by QbD

Data Integrity & Microbial Air Monitoring Technique in Grade A Seminars場次一、時間：108/6/10 (一) 14:00-17:00地點：成大光復校區國際會議廳第三演講室

701 台南市東區大學路1號B1場次二、時間：108/6/12 (三) 09:00-12:00地點：竹北生醫園區生技大樓112會議室

302 新竹縣竹北市生醫路二段18號1F

我要報名：

□場次一、成大場 6/10 (一) 下午 14:00-17:00

□場次二、竹北場 6/12 (三) 上午 09:00-12:00

姓名：________________先生/ 小姐

公司：_____________________

部門：________________ 職稱：___________________

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名額有限，報名從速~~

美國PMS公司台灣分公司報名表請傳真至：03-5525399 新竹辦事處、06-5839179 台南辦事處或寄至： E-mail：slin@pmeasuring.com 聯絡人：林曉聖 (0905306017)