ONLINE COURSE

GMP Documentation Management in Life Sciences

Specialized Training in Good Documentation Practices (GMP).

What will you learn?

You will understand the fundamental principles of documentation management in a GMP environment.
You will learn about international standards such as FDA (21 CFR 211, Subpart J) and EU GMP (Chapter 4).
You will become familiar with essential Data Integrity practices to ensure quality and traceability in documentation.
You will understand the responsibilities and requirements related to documentation in the pharmaceutical sector.

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ONLINE
(only in Spanish)

2,5 hours

195€

per person

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Content
- Introduction to Good Documentation Practices (GMP).
- International regulatory requirements: DA and EU GMP.
- The importance of Data Integrity in document management.
- Responsibilities in documentation handling according to FDA and EMA.
- How to manage CAPA (Corrective and Preventive Actions) efficiently.
- Best practices, in paper-based and electronic documentation.
Target audience
- Professionals in production, quality, IT, engineering, or any area related to documentation management in the pharmaceutical and biotech sectors.
Details

Timetable: flexible, you set the pace.

Accessibility: recorded course. 24/7 access to learn at your own pace.

Customized: Tailored training adapted to your or your company’s needs.

Language: Spanish.

Payment by Bank Transfer: if you prefer to buy this training via bank transfer, send us an email at academy@ambit-iberia.com

Invoicing: if you need an invoice in your company's name, enter all the details when purchasing the training, after 'complete purchase,' and the Ambit Iberia admin team will send it by email after the purchase.
Discounts
- 15% OFF when enrolling in more than one course.
- 15% OFF for groups from the same company.
- 15% OFF if you are a member of Catalonia.Health, Barcelona Health Hub or Madrid Health Hub.