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Compliance4All - carte de visite : 15 résultats

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Project Management for Non-Project Managers 2018

Réf: 27495 Mercredi 01 Août 2018 - En ligne

The webinar is designed to build a working understanding of the subject and for a quick start-up
for those unanticipated project management assignments.

Formation: Médecine, Médecine générale, Management

Historical Perspective of the Part 11 Regulation

Réf: 27496 Lundi 06 Août 2018 - En ligne

This presentation will provide an overview and historical perspective of the Part 11 regulation,
the general Part 11 requirements, electronic records requirements, and
electronic signatures requirements.

Formation: Médecine, Médecine générale, Management, Santé Publique

Best Practices to Support FDA Computer System Validation

Réf: 27497 Mardi 07 Août 2018 - En ligne

Overview: We will cover the importance of maintaining the documentation from every computer system validation effort in a "current" state. The system must be maintained in a validated state throughout its entire life cycle, and the accompanying validation documentation must also be ...

Formation: Pharmacie, Médecine, Bio-Technologies, Médecine générale, Management, Santé Publique

How to Identify and Eliminate Multiple Root Causes

Réf: 27507 Mercredi 08 Août 2018 - En ligne

Overview:   Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.   Why ...

Formation: Pharmacie, Médecine, Bio-Technologies, Informatique

Spreadsheets for 21 CFR 11 Compliance 2018

Réf: 27498 Vendredi 10 Août 2018 - En ligne

Overview: Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance.   Areas Covered in the ...

Formation: Médecine, Médecine générale, Management

Validation Under Good Laboratory Practices

Réf: 27508 Lundi 13 Août 2018 - En ligne

Overview: This webinar will discuss the best practices of analytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability, importance of communication between the development and the validation ...

Formation: Médecine, Pharmacie, Santé Publique

When to Submit a 510(k) for a Change to an Existing Device

Réf: 27499 Mardi 14 Août 2018 - En ligne

Overview: This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k)   Why should you Attend: This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers ...

Formation: Pharmacie, Bio-Technologies, Santé Publique

Cloud Software Applications for 21 CFR Part 11

Réf: 27500 Mardi 14 Août 2018 - En ligne

Overview: This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.   Areas Covered in the Session: Which data and systems are subject to Part 11 What Part 11 means to you, not just what it says in ...

Formation: Pharmacie, Médecine, Santé Publique, Management

Design Control is Critical to Product Quality

Réf: 27501 Mardi 14 Août 2018 - En ligne

Overview: This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency.   Why should you Attend: Design Control is not only a regulatory ...

Formation: Médecine, Santé Publique, Management

Verification vs Validation-Product, Equipment and QMS Software

Réf: 27502 Mercredi 15 Août 2018 - En ligne

Overview: You will learn What do the U.S. FDA and EU Expect for Verification and Validation, Actions and documentation to meet U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements, ISO 14971 and IEC 62366 considerations, as appropriate.   Why should you ...

Formation: Médecine, Toxicologie, Santé Publique

When Conducting cGMP Regulatory Inspections 2018

Réf: 27503 Jeudi 16 Août 2018 - En ligne

Overview: This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or ...

Formation: Pharmacie, Médecine, Bio-Technologies, Santé Publique

CAPA for Medical Devices 2018

Réf: 27509 Mercredi 22 Août 2018 - En ligne

Overview:  You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. In this 3-hour webinar, you'll learn how to streamline and monitor your process to ensure compliance and improved ...

Formation: Médecine, Pharmacie, Bio-Technologies, Santé Publique

Revolutionary Change in FDA Software Regulation

Réf: 27504 Mardi 28 Août 2018 - En ligne

Overview: It is not about giving an OK to products, it is about trusting the manufacturer to do the right thing. Overall, your regulatory approach to software regulation needs to ease up and reap the benefits where they apply. Your company may even save money, a nice benefit.   Why ...

Formation: Médecine, Pharmacie, Bio-Technologies, Toxicologie, Santé Publique

What you Need to Know to Prepare FDA Inspection

Réf: 27505 Jeudi 30 Août 2018 - En ligne

Overview: Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively.   Why should you ...

Formation: Médecine, Toxicologie, Santé Publique

What are the Tools required for Human Error Reduction

Réf: 27506 Jeudi 30 Août 2018 - En ligne

Overview: This course offers practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.   Areas Covered in the Session: Background on Human Error Phenomena ...

Formation: Pharmacie, Médecine, Bio-Technologies, Management