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Conférences en ligne Biomedical : When to Submit a 510(k) for a Change to an Existing Device
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 present...
Secteurs concernés: Biomedical -Santé publique -
Conférences en ligne Acupuncture : Cloud Software Applications for 21 CFR Part 11
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 a...
Secteurs concernés: Acupuncture -Médecine générale -
Conférences en ligne Santé publique : Design Control is Critical to Product Quality
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 quali...
Secteurs concernés: Biotechnologie -Santé publique -
Conférences en ligne Biochimie : Verification vs Validation-Product, Equipment and QMS Software
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...
Secteurs concernés: Biochimie -Biotechnologie -
Conférence / Séminaire Acupuncture : FDA Software Monsters Cybersecurity, Interoperability, Mobile Apps and Home Use
Race "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC r...
Secteurs concernés: Acupuncture -Droit et santé -
Conférences en ligne Biotechnologie : When Conducting cGMP Regulatory Inspections 2018
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 wi...
Secteurs concernés: Biotechnologie -Santé publique -
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 -
Conférence / Séminaire Management médico-hospitalier : 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
  Course "21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertif...
Secteurs concernés: Biomedical -Management médico-hospitalier -
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