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Supplementary Material: "How to Conduct Overseas GMP Audits"

Supplementary Material: "How to Conduct Overseas GMP Audits"

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

"How to Conduct Overseas GMP Audits" is a supplementary material designed to deepen understanding of pharmaceutical GMP audit procedures in English and to enhance skills for effectively conducting audits in English as a GMP auditor. It explains common questions about GMP audits in an easy-to-understand Q&A format. Additionally, it provides opportunities for practical training through meeting role-plays, presentations, and discussion exercises based on real-life problem cases, fostering practical response capabilities. 【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 ■ Foster practical response capabilities ■ 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.

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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 situations. You will comprehensively understand various specialized English expressions used in 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 practical exercises using your company's specific pharmaceutical materials and on-site practice, in addition to the provided materials. 【Contents】 ■I. Key Points of Inspection Response ■II. Specialized Vocabulary Review ■III. Specialized Vocabulary Exercises ■IV. Role-Playing Activities *For more details, please refer to the PDF materials or feel free to contact us.

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Supplementary Material: "Skills for Responding to Audits of Overseas Clinical Trial Sites"

Supplementary Material: "Skills for Responding to Audits of Overseas Clinical Trial Sites"

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

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

  • Employee training

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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 allows for a deeper understanding of particularly important risk management measures in the GVP guidelines in Europe in English. Additionally, it provides practice in acquiring basic concepts, vocabulary, and specialized terms, and applying them in discussions. 【Features】 ■ Deepen understanding of the key points of risk management in the GVP guidelines in English ■ Acquire basic concepts, vocabulary, and specialized 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.

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