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Supplementary Material: "How to Conduct Overseas GMP Audits"

Supplementary Material: "How to Conduct Overseas GMP Audits"

Improving skills to effectively conduct audits in English! Deepening understanding of pharmaceutical GMP audit procedures in English.

"The Guide to Conducting Overseas GMP Audits" is a supplementary material designed to deepen understanding of the procedures for pharmaceutical GMP audits in English and to enhance skills for effectively conducting audits in English as a GMP auditor. It clearly explains common questions about GMP audits in a Q&A format. Additionally, it develops practical response skills through meeting role plays, presentations, and discussion practice based on actual problem cases. 【Features】 ■ Deepen understanding of the overseas GMP audit process and key points in English ■ Clearly explain common questions about GMP audits in a Q&A format ■ Develop practical response skills ■ It is also possible to utilize your company's original materials and case studies *For more details, please refer to the PDF document or feel free to contact us.

  • Business Skills Seminar

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Supplementary Material "Pharmaceutical Inspection Response Guidebook"

Supplementary Material "Pharmaceutical Inspection Response Guidebook"

Improve practical response skills through simulation role-playing and discussions!

In the "Inspection Response Guidebook," you will acquire practical English skills, manners, and effective response methods for inspection responses. You will be able to comprehensively understand various specialized English expressions for responding to inspections by authorities such as the FDA and EMA, as well as effective inspection response methods and manners. In-class training can include more practical exercises, utilizing your company's specific pharmaceutical materials and on-site practice in addition to this teaching material. [Contents] ■ I. Key Points of Inspection Response ■ II. Confirmation of Specialized Vocabulary ■ III. Specialized Vocabulary Exercises ■ IV. Role-Play Activities *For more details, please refer to the PDF materials or feel free to contact us.

  • Distance learning/E-learning

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Supplementary Teaching Material "Skills for Responding to Audits of Overseas Clinical Trial Facilities"

Supplementary Teaching Material "Skills for Responding to Audits of Overseas Clinical Trial Facilities"

Improve practical response capabilities! Acquire specialized English expressions and effective communication methods.

The "Skills for Responding to Audits of Overseas Clinical Trial Sites" is a supplementary material that allows you to acquire practical English skills for overseas clinical trial site audits, as well as interview skills and effective communication methods with principal investigators, CRCs, and drug management personnel. You will learn interview techniques based on actual problem cases and improve your practical response abilities through simulation role plays and discussions. 【Features】 - Acquire important points in interviews and various specialized English expressions - Learn interview techniques based on actual problem cases - Improve practical response abilities - Use your company's specific pharmaceutical materials for more practical practice *For more details, please refer to the PDF document or feel free to contact us.

  • Business Skills Seminar

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Supplementary Material: "Key Points of GVP Revisions in Europe (EMA)"

Supplementary Material: "Key Points of GVP Revisions in Europe (EMA)"

Deepen your understanding of the key points of the revision in English! Improve your discussion skills.

"The key points of the GVP revision in Europe (EMA)" is a supplementary material designed to deepen understanding of the revision points of the GVP guidelines and to enhance discussion skills. It is possible to deepen understanding of particularly important risk management measures in the GVP guidelines in Europe in English. Additionally, you will acquire basic concepts, vocabulary, and technical terms, and practice applying them in discussions. 【Features】 ■ Deepen understanding of the key points of risk management measures in the GVP guidelines in English ■ Acquire basic concepts, vocabulary, and technical terms ■ Practice applying them in discussions ■ It is also possible to utilize your company's original materials and case studies *For more details, please refer to the PDF document or feel free to contact us.

  • Business Skills Seminar

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