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Aseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment Survey

Hello. This is Juan Shao with Scott Wheelwright at Complya Asia. We plan to provide training for aseptic processing and would like your opinion about our program. 您好。我是苏州智真生物医药咨询有限公司的邵娟，我跟Scott Wheelwright博士共事。我们公司计划提供无菌工艺方面的培训，希望可以了解您对我们计划的意见和建议。 We are conducting a survey on your needs for aseptic training and would like to ask you a few questions about your requirements in this area. We plan to offer aseptic training courses based on the results of this survey. Thank you for your time. 目前我们正在进行一个关于无菌培训的需求调查，想问几个您在该领域的需求问题。我们计划根据此次调查结果提供相应的无菌培训课程。非常感谢您能抽出时间来帮助我们。 Confidentiality: we will not share your information with other companies. 保密:我们绝不会把您的信息透露给其他公司。 We want to understand what you need and how our training can help you. 我们只是想要了解您的需求以及我们怎样能帮到您。

Respondent Information 参参参参与与与与调调调调查查查查者信息者信息者信息者信息

1. Please describe your biggest challenges with aseptic processing and explain what you mean .请请请请您您您您描述一下描述一下描述一下描述一下您您您您在在在在无无无无菌工菌工菌工菌工艺艺艺艺方面最大的挑方面最大的挑方面最大的挑方面最大的挑战战战战，，，，并并并并详细详细详细详细描述。描述。描述。描述。

Introduction:

Respondent Name 参与调查者姓名:

Company 公司名称:

Title职称：

Email Address邮箱:

Telephone电话:

Address 地址

documentation 文件

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equipment 仪器设备

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employee training员工培训

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technical understanding技术理解

gfedc

Aseptic Techniques无菌技术

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Gowning洁净服穿着

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Cleaning and sanitization清洁和消毒

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Environmental Monitoring环境监控

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Maintenance维护保养

gfedc

Smoke studies烟雾试验

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其他（请按照重要性排序并指明最重要的一个，详细介绍）

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Aseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment Survey2. If you were to attend a course, what would you like the focus to be? (Please rank the order, with 1 being most important). Please provide details.如果如果如果如果您您您您要要要要参参参参加一加一加一加一门课门课门课门课程，程，程，程，您您您您希望希望希望希望

重重重重点点点点集中在集中在集中在集中在哪哪哪哪部分？（部分？（部分？（部分？（请请请请排序排序排序排序并并并并写写写写出最重要的一出最重要的一出最重要的一出最重要的一个个个个））））请详细请详细请详细请详细描述。描述。描述。描述。

3. For your line workers, what is the most important training they need? Please provide details. 你你你你们们们们的生的生的生的生产线产线产线产线工人需要的最重要的培工人需要的最重要的培工人需要的最重要的培工人需要的最重要的培训训训训是什是什是什是什么么么么？？？？请详细请详细请详细请详细描述。描述。描述。描述。

Would you be interested in a course for line operators in Hangzhou ？那？那？那你你你你们们们们是否愿意送是否愿意送是否愿意送是否愿意送

生生生生产线产线产线产线工人到杭州工人到杭州工人到杭州工人到杭州进进进进行培行培行培行培训训训训？？？？

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theory理论

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practice实践

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facility design厂房设计

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quality assurance质量保证

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testing测试

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cleaning清洁

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sterilization灭菌

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其他（请按照重要性排序并指明最重要的一个，详细介绍）

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gowning洁净服穿戴

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technique practice技术实践操作

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aseptic training certification (how important is certification)无菌培训证书（证书为何重要）

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gowning certification洁净服穿戴证书

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industry­accepted cert for new employee新员工业内认可的证书

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air sampling (environmental monitoring) 空气取样（环境监控）

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Cleaning and sanitization清洁和消毒

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其他（请指明）

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Aseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment Survey If no, 如果不如果不如果不如果不 会会会会

4. What other training would be useful to your company?其他的什其他的什其他的什其他的什么么么么培培培培训课训课训课训课程程程程对贵对贵对贵对贵公司公司公司公司会会会会比比比比

较较较较有用？有用？有用？有用？

5. Which level of GMP does your company need?你你你你们们们们公司需要遵循什公司需要遵循什公司需要遵循什公司需要遵循什么么么么标标标标准的准的准的准的GMP？？？？

6. Who else in your company should we talk to about this? 我我我我们还们还们还们还需要跟需要跟需要跟需要跟贵贵贵贵公司其他的人公司其他的人公司其他的人公司其他的人讨讨讨讨

论论论论一下一下一下一下吗吗吗吗？？？？

Would you be interested in a course for line operators at your site? 那你们是否愿意在你们设施内对生产线工

人进行培训

How many staff would you want to attend预期会有多少

人参加？

How many shifts do you run需要几轮？

How long (4 hours; 8 hours; 2 days) 培训多长时间（4小时，8小时，2天）

What cost both total for company and per employee 以公

司为单位计算和按照单个员工计算的总的培训费用

为多少？

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QA, QC and environmental monitoring质量保证，质量控制和环境监控

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engineering, facility design and operation工程，厂房设计和运营

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Risk Assessment 风险评估

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Investigations and CAPA调查及纠正和预防措施

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Management管理

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Design设计

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Validation验证

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其他（请指明）

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China only只遵循中国

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International 遵循国际

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其他（请指明）

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Aseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment Survey7. For the course that you would attend对对对对 那些那些那些那些您您您您想想想想参参参参加的加的加的加的课课课课程程程程

8. We have a new training facility in Hangzhou that is a full grade B and grade A area.我我我我 们们们们

在杭州有一在杭州有一在杭州有一在杭州有一个个个个新的培新的培新的培新的培训设训设训设训设施，是一施，是一施，是一施，是一个个个个完整的完整的完整的完整的A级级级级和和和和B级级级级区区区区。。。。

9. How far in advance to you plan your training budget? 您您您您需要多久需要多久需要多久需要多久来来来来申申申申请请请请您您您您的培的培的培的培训预训预训预训预算？算？算？算？ ­ 3 months, 6 months, one year 3个个个个月，月，月，月，6个个个个月，月，月，月，1年年年年

10. What information will your boss need in order to approve your attendance? 要批准要批准要批准要批准您您您您参参参参

加培加培加培加培训训训训，，，，您您您您的老板需要的老板需要的老板需要的老板需要哪哪哪哪些信息？些信息？些信息？些信息？

How many days long do you think is necessary?您认为多长时间是必需的？ 3, 4, 5, or more 3天，4天，5天或

者更多

What other courses have you attended (what were the most productive courses you attended) 您曾经参加过其他什么培训

课程（您参加过的最有收获的课程有

哪些）

How long were they课程时长多少

How much did they cost (how much per day) 花费多少（一天多少钱）

What level individual would your company send to Hangzhou for training?贵公司会

送哪个级别的人来杭州参加培训？

­ manager, director, VP经理，主任，副

总 ­ supervisor, line operator主管，生产线工

人

How long should the course be课程多少时

间比较合适？

Note：

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Aseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment Survey11. If your boss receives this information then would you sign up? 如果老板收到此信息，如果老板收到此信息，如果老板收到此信息，如果老板收到此信息，您您您您

可以可以可以可以签约签约签约签约参参参参加加加加

12. Which of the following courses would be of most interest to you and your company? 您您您您和和和和贵贵贵贵 公司分公司分公司分公司分别对别对别对别对 下面下面下面下面面哪 哪个个个个课课课课程最感程最感程最感程最感兴兴兴兴趣？趣？趣？趣？

Course 1: introduction to aseptic processing 课课课课程一：程一：程一：程一：无无无无菌工菌工菌工菌工艺艺艺艺介介介介绍绍绍绍 ­ 5 days, 5天天天天 ­ detailed theory on why we do what we do关关关关于于于于为为为为什什什什么么么么要要要要这这这这么么么么做的做的做的做的详细详细详细详细理理理理论论论论 ­ international and local regulations国国国国际际际际和本和本和本和本国国国国法法法法规规规规 ­ facility design厂厂厂厂房房房房设计设计设计设计 ­ hands on practice实实实实践践践践操作操作操作操作 ­ environmental monitoring环环环环境控制境控制境控制境控制

Course 2: Microbial identification 课课课课程二：微生物程二：微生物程二：微生物程二：微生物鉴鉴鉴鉴定定定定 ­ how to identify the species of microorganisms found in your facility如何如何如何如何鉴鉴鉴鉴定定定定设设设设施里施里施里施里发现发现发现发现

的微生物的微生物的微生物的微生物种种种种类类类类

Course 3： ： ： ： Detailed gowning qualification 课课课课程三：程三：程三：程三：详细详细详细详细的的的的洁洁洁洁净净净净服穿服穿服穿服穿着着着着资质资质资质资质 ­ how to gown properly如何正如何正如何正如何正确确确确的穿戴的穿戴的穿戴的穿戴洁洁洁洁净净净净服服服服

Would you like to come? 您想要来参加培

训吗？

If no, what course would you like to attend? 如果不想，那您希望参加什么课程？

Other：

Specific Courses 专项课专项课专项课专项课程程程程

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How many days？课程时长

Chinese or English中文还是英文

Other

How many days? 课程时长

Chinese or English中文还是英文

Other

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Aseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment SurveyAseptic Training Needs Assessment Survey Course 4：：：：Training the trainer 课课课课程四：培程四：培程四：培程四：培 训训训训培培培培训师训师训师训师

13. Can you recommend any other manufacturing company (or friend) we might invite to participate in this survey? 您您您您能否有其他的能否有其他的能否有其他的能否有其他的药药药药物生物生物生物生产产产产公司（或者朋友），我公司（或者朋友），我公司（或者朋友），我公司（或者朋友），我们们们们可以邀可以邀可以邀可以邀请请请请他他他他们们们们

也也也也来参来参来参来参与与与与这这这这个个个个调调调调查查查查？？？？

Thank you for your time and contribution to our survey. We will provide you with further information once the training course is established. We welcome you to attend our professional aseptic training. 感谢您抽时间参加我们的调查。课程确定后我们会及时通知您。欢迎您参加我们专业的无菌工艺培

训来推动您职业的进一步发展。Please send completed survey to Juan.Shao@complya-asia.com.hai

请将完成的调查问卷发送到邮箱Juan.Shao@complya-asia.com .

Which area do you want to train your trainer?您希望对您的培训师进行哪方

面的培训？

How many days? 您期望的课程时长

Other

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