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Liste des formations santé : 88 résultats

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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

Understanding Autism Spectrum Disorder (ASD): Preparing Students to Transition to College and Succeed

Réf: 27639 Mercredi 05 Septembre 2018 - Fremont US

  Training Options  Duration: 90 Minutes   Wednesday, September 5, 2018   |   10:00 AM PDT | 01:00 PM EDT   Overview: This webinar will identify the range of individual characteristics displayed by students on the Autism Spectrum, explain what ...

Formation: Médecine, Pharmacie, Hôpital

Upcoming HIPAA Audits - How to Avoid and Be Prepared

Réf: 27636 Jeudi 06 Septembre 2018 - Fremont US

  Training Options  Duration: 90 Minutes   Thursday, September 6, 2018   |   10:00 AM PDT | 01:00 PM EDT   Overview: We will be discussing some of the changes taking place in Washington with the Health and Human Services in regards to the ...

Formation: Hôpital, Pharmacie

Empowering the Latino Immigrant Family as Partners in Education -What you Need to Know

Réf: 27631 Vendredi 07 Septembre 2018 - Fremont US

  Training Options  Duration: 60 Minutes   Friday, September 7, 2018   |   10:00 AM PDT | 01:00 PM EDT   Overview: Empowering the immigrant parent as a partner in their children's education is critical if we desire immigrant students to be ...

Formation: Hôpital, Pharmacie

Webinar On Behavior Health Coding and Documentation

Réf: 27633 Vendredi 07 Septembre 2018 - Fremont US

  Training Options  Duration: 90 Minutes   Friday, September 7, 2018   |   10:00 AM PDT | 01:00 PM EDT   Overview: Evaluation and Management codes are often vulnerable to third-party auditor scrutiny. Payers frequently use different types of ...

Formation: Hôpital

Fraud & Abuse,Stark & Anti-Kickback Issues

Réf: 27634 Vendredi 07 Septembre 2018 - Fremont US

  Training Options  Duration: 60 Minutes   Friday, September 7, 2018   |   10:00 AM PDT | 01:00 PM EDT   Overview: The presentation will provide an overview of the Federal Stark and Anti-Kickback laws and corresponding regulations including the ...

Formation: Pharmacie, Médecine

FDA During New (Drug) Development 2018

Réf: 27653 Vendredi 07 Septembre 2018 - En ligne

Overview:  Why is it important to engage with the FDA?   To discuss your development plan to support NDA or BLA regulatory submission To identify and mitigate potential issues early To identify any critical issues and aspects of your program such ...

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

Best Practices for Foundational (Employee) Success 2018

Réf: 27641 Lundi 10 Septembre 2018 - En ligne

Overview: FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best achieve compliance for its employees, maintain a quality culture, and manage the work ...

Formation: Médecine, Pharmacie

Compliance for Electronic Records and Signatures (21 CFR Part 11)

Réf: 27642 Lundi 10 Septembre 2018 - En ligne

Overview: Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using ...

Formation: Pharmacie, Médecine, Infectiologie - Hygiène

Highlights of FDA GLP Regulations and the (Roles) and Responsibilities

Réf: 27654 Lundi 10 Septembre 2018 - En ligne

Overview:  This 3 hour GLP virtual seminar will discuss various GLP regulations (FDA/OECD GLP's) along with highlighting roles and responsibilities of management and key personnel involved in drug development, safety & toxicity evaluation and QAU function in GLP testing ...

Formation: Pharmacie, Médecine, Bio-Technologies, Infectiologie - Hygiène, Sécurité sociale, Santé Publique

Managing and Examining Travel and Entertainment (Expense 2018)

Réf: 27643 Mardi 11 Septembre 2018 - En ligne

Overview: This course provides insight on how to bring control and intelligent management to your company's T&E process.We evaluate how to bring people, process, technology, strategy and information together to provide the proper level of internal controls over expenditures.We also discuss ...

Formation: Médecine, Pharmacie, Santé Publique, Toxicologie

Improving Compliance and your Company's Bottom Line (MedicalDevice Cybersecurity)

Réf: 27644 Mardi 11 Septembre 2018 - En ligne

Overview: This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats. Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection,...

Formation: Pharmacie, Médecine, Santé Publique

Compliance for Risk Based Approaches for (Clinical Trials 2018)

Réf: 27645 Mercredi 12 Septembre 2018 - En ligne

Overview: FDA and EMA have communicated their expectations for trial oversight/ monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations: A Risk- Based Approach to Monitoring and the EMA Reflection Paper on ...

Formation: Médecine, Pharmacie, Santé Publique

Project Management for Non-Project Managers (2018 Estimating Resource Needs)

Réf: 27646 Mercredi 12 Septembre 2018 - En ligne

Overview: This webinar will explore how to most effectively apply both the human and non-human resources to project tasks that you require to achieve your project's outcome.Once you have identified and allocated your available resources, you must "level"how those resources are used across the ...

Formation: Pharmacie, Médecine, Santé Publique

Quality Agreements Made Easy (Advanced 2018)

Réf: 27647 Vendredi 14 Septembre 2018 - En ligne

Overview: The requirements for the assurance of quality within networks and circles of entities whose responsibilities are increasing specialized present an especially vexing challenge to the managements of each of these organizations. The specification developer must be aware of the ...

Formation: Médecine, Pharmacie, Santé Publique

cGMPs in the Quality Control Laboratory (Medical 2018)

Réf: 27648 Vendredi 14 Septembre 2018 - En ligne

Overview: In this webinar we will apply one aspect of this proactive approach, the review regulatory requirements and analysis of 483 and Warning Letter observations to determine if similar observations could be made in the participants facility and provide a stimulus to initiate preventive ...

Formation: Pharmacie, Médecine, Toxicologie, Santé Publique, Management

Risk Control According to (GxP-GMP) Requirements

Réf: 27655 Vendredi 14 Septembre 2018 - En ligne

Overview:  GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. Documentation is a critical tool for ensuring GxP/GMP compliance. In order to maintain documentation in GxP/GMP compliant manner, ...

Formation: Pharmacie, Médecine, Santé Publique

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