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Conférences en ligne Biotechnologie : Revolutionary Change in FDA Software Regulation
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...
Secteurs concernés: Biotechnologie -
Conférence / Séminaire Biotechnologie : What you Need to Know to Prepare FDA Inspection
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 w...
Secteurs concernés: Biotechnologie -
Conférences en ligne Biotechnologie : What are the Tools required for Human Error Reduction
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...
Secteurs concernés: Biotechnologie -
Conférences en ligne Biotechnologie : FDA During New (Drug) Development 2018
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 identi...
Secteurs concernés: Biotechnologie -
Conférences en ligne Biotechnologie : Best Practices for Foundational (Employee) Success 2018
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 ac...
Secteurs concernés: Biotechnologie -
Conférences en ligne Biotechnologie : Compliance for Electronic Records and Signatures (21 CFR Part 11)
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 valida...
Secteurs concernés: Biotechnologie -
Conférences en ligne Biotechnologie : Highlights of FDA GLP Regulations and the (Roles) and Responsibilities
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 i...
Secteurs concernés: Biomedical -Biotechnologie -
Conférences en ligne Biotechnologie : Quality Agreements Made Easy (Advanced 2018)
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 managem...
Secteurs concernés: Biomedical -Biotechnologie -
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BIOTECHNOLOGIE ARCHIVES : LES EVENEMENTS, CONGRES MEDICAUX PASSES...
Colloque Informatique médical : 21 CFR Part 11 compliance for software validation and SaaS/Cloud Seminar 2018
Course "21 CFR Part 11 compliance for software validation and SaaS/Cloud" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon ...
Conférences en ligne Biotechnologie : What is the Regulatory Structure in Japan 2018
Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. ...
Conférences en ligne Biotechnologie : Essential Training for IRB Members and Staff
Overview: This webinar serves will provide substantive training of the criteria for IRB approval for new IRB members/staff who have less than three years of experience. Why should you Attend...
Congrès Santé publique : Forum FAMxParis sur l'Innovation inversée en santé
L’innovation inversée : Une opportunité pour la santé dans le monde Après six Forums en bilatéral, la Fondation de l’Académie de Médecin...
Colloque Biologie : A Risk Based Approach to IT Infrastructure Seminar 2018
Course "A Risk Based Approach To IT Infrastructure & Cloud Qualification, Compliance & Control" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant&#...
Colloque Biologie : Understanding of HIPAA Rules | HIPAA Compliance 2018
Overview: In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Complia...
Colloque Biologie : New EU Medical Device Regulation | Updated Regulation 2018
Course "The New EU Medical Device regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview...
Colloque Biologie : Process Validation General Principle and Practices - Philadelphia 2018
Course "Applied Statistics for FDA Process Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. O...
Colloque Biologie : Clinical Data Management - Benefits of Standardization in Establishing CDM Processes
Course "Clinical Data Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: When new dr...
Colloque Biologie : Promotion & Advertising Practices 2018 under FDA Observation
Course "FDA Scrutiny of Promotion and Advertising Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completi...
Colloque Biologie : Root Cause Analysis: Foundation of Investigations and CAPA
Course "Root Cause Analysis: Foundation of Investigations and CAPA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full c...

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