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21 CFR Part 11 Guidance for Electronic Records - 2018

Réf: 26779 Jeudi 21 Juin 2018 - En ligne

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Formation: Pharmacie, Bio-Technologies, Informatique, Management

Drug Substances and Drug Products - Specifications

Réf: 26778 Mercredi 23 Mai 2018 - En ligne

Learn requirements for changing specifiations through the lifestyle of the product.

Formation: Médecine, Pharmacie, Bio-Technologies, Sécurité sociale, Management

Manufacturing Safety - What you don't Know can Harm you

Réf: 26777 Vendredi 18 Mai 2018 - En ligne

In this webinar, we will explore the hazards related to the manufacturing facility on many fronts.

Formation: Pharmacie, Bio-Technologies, Informatique, Management, Sécurité sociale

Investigator Reporting Responsibilities - OHRP

Réf: 26776 Vendredi 18 Mai 2018 - En ligne

A comparison will be provided for the AE reporting requirements for drugs and devices.

Formation: Pharmacie, Bio-Technologies, Management

C-TPAT - Trade Partnership Against Terrorism 2018

Réf: 26775 Lundi 14 Mai 2018 - En ligne

How to develop a standard approach to complying with the voluntary C-TPAT guidelines, and Strategies for reducing the cost and complexity of compliance with C-TPAT.

Formation: Pharmacie, Bio-Technologies, Management, Sécurité sociale

Fundamentals of Risk Management in Clinical Research 2018

Réf: 26774 Vendredi 04 Mai 2018 - En ligne

Practical aspects of developing key performance and quality indicators at all stages of clinical trials will be discussed.

Formation: Pharmacie, Management, Sécurité sociale

How to Comply with 21 CFR 11 Requirements

Réf: 26773 Mercredi 02 Mai 2018 - En ligne

What are future expectations for EMRs (FDA Draft Guidance) and the impact on sponsors and sites.

Formation: Pharmacie, Management, Sécurité sociale

Antimicrobial Stewardship: Implementing the Change

Réf: 26705 19/04/2018 -> 20/04/2018 - San Lorenzo de El Escorial ES

  Course Objectives: - To understand the scientific background of antimicrobial stewardship interventions. - To understand the sociocultural, ethical and behavioral aspects of antimicrobial stewardship. - To acknowledge the relevance of the quality management/implementation aspects ...

Formation: Médecine

17th ESCMID Summer School

Réf: 26690 01/07/2018 -> 07/07/2018 - Paris FR

  Aim and Target Audience: A one-week course dedicated to postgraduate and continuing medical education. The programme covers a broad range of topics in clinical microbiology and infectious diseases and will interest young MDs at the end of their specialty training as well as biologists, ...

Formation: Médecine

Adult Immunization: New and Old Challenges

Réf: 26689 16/03/2018 -> 17/03/2018 - Sao Paulo BR

  Course Objectives:  Discuss different aspects related to immunization in adults:    - importance and challenges of adult immunization.  - immune response in elderly.  - vaccine schedule for adults, immunocompromised patients, healthcare workers and ...

Formation: Sécurité sociale

Veterinary Hospital Infect. Control and Antimicrob. Stewardship

Réf: 26686 Mercredi 04 Avril 2018 - Birmingham GB

  Challenges in Veterinary Hospital Infection Control and Antimicrobial Stewardship.   Course Objectives: The objectives are to promote hospital infection control and antimicrobial stewardship in small animal practice and to educate a new generation of veterinary infectious ...

Formation: Hôpital

Journee Debat Perse 2018

Réf: 26671 Mercredi 04 Avril 2018 - Paris FR

"Prise en charge de l'escarre : croyances, connaissances et bonnes pratiques"

Formation: Gériatrie, Méd. phys. & de réadaptation, Médecine générale, Recherche

Label Promotion of Drugs and Medical Devices

Réf: 26604 Mardi 24 Avril 2018 - En ligne

Overview: This session sets the context for the off-label promotion of medical    products starting with early history and moving to the most recent history    of FDA's decision on guidance documents.   Why should you Attend: This class presents the latest ...

Formation: Pharmacie, Pour le public

How a Quality and Lean Steering Committee can be Effectively Utilized

Réf: 26603 Vendredi 20 Avril 2018 - En ligne

How a quality and lean steering committee can be effectively utilized in any type of organization.

Formation: Pharmacie, Pour le public

ISO 62366 - How to Conduct a Human Factors

Réf: 26602 Mercredi 18 Avril 2018 - En ligne

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Formation: Médecine, Pharmacie, Pour le public

Failure Modes - How to use these Kinds of Methods Together

Réf: 26601 Mercredi 18 Avril 2018 - En ligne

This presentation provides you with the information you need to for effective FMEA use

Formation: Pharmacie, Médecine, Pour le public

Understanding and Meeting your Regulatory & Processing Responsibilities

Réf: 26600 Lundi 16 Avril 2018 - En ligne

How DMFs fit into FDA's regulatory processes for review of drug and biologic applications.

Formation: Pharmacie, Médecine, Pour le public

Best Practices for Foundational Employee Success 2018

Réf: 26599 Mercredi 11 Avril 2018 - En ligne

Learn to interact with Human Resources to create a coordinated onboarding strategy

Formation: Pharmacie, Pour le public

ISO 13485 & ISO 9001 - How to Choose Which One to Implement

Réf: 26598 Mardi 10 Avril 2018 - En ligne

Attending this webinar will provide information to help organizations make the best decisions for their business.

Formation: Pharmacie, Médecine, Pour le public

Compliance for Electronic Records and Signatures 2018

Réf: 26597 Vendredi 06 Avril 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 ...

Formation: Médecine, Pharmacie, Pour le public

Quality Audit According to Gxp-GMP Requirements 2018

Réf: 26596 Vendredi 06 Avril 2018 - En ligne

Overview: GMP regulations describe required quality management system for    production and testing of products in these regulated industries. The    purpose of the GMP regulations is to ensure that a product is safe and    meets its intended ...

Formation: Médecine, Pour le public

Medical Device Single Audit Program Preparation

Réf: 26595 Vendredi 06 Avril 2018 - En ligne

Overview: The International Medical Device Regulators Forum (IMDRF) recognizes    that a global approach to auditing and monitoring the manufacturing of    medical devices could improve their safety and oversight on an    international ...

Formation: Médecine, Pharmacie, Management

Validation for the New FDA Inspections

Réf: 26594 Jeudi 05 Avril 2018 - En ligne

How to conduct a software validation program that will satisfy FDA requirements and produce a safe product.

Formation: Pharmacie, Médecine, Management, Toxicologie

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