Beruflich Dokumente
Kultur Dokumente
Los Angeles
About GCPseminars:
GCPseminars is a training source that delivers diverse, high quality regulatory & compliance trainings. These
trainings are simple while being relevant and cost-effective while being convenient. GCPseminars imparts
knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars,
conferences and tailored, individualized consulting. These help organizations and professionals implement
compliance programs that meet regulatory demands and put business processes in place. Through our trainings,
we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn
or be aware of those regulations, on the other.Our services benefit the Medical Devices, Pharmaceutical, Bio
Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clientele includes
companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune
500 companies. Professionals who undergo trainings from GCPseminars exhibit a vastly improved quality of life in
which there is increased productivity and professional growth. Some 30,000 professionals have gained from more
than 500 training courses we have conducted till now
www.gcpseminars.com
seminars
Overview :
Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit.
Problems with software create a number of different hurdles. Software may be a standalone device, control a device's
performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions
regarding patient management and treatment.
Agenda:
Day 1:
Day 2:
Lecture 1: Cybersecurity
Regulatory strategy
Pre-emption design
Risk classication
Latent malware/virus
Post-event management
Disclosure to users
Information Protection
Premarket submissions
Paradigms: aeronautics
apps)
Mobile apps dened as a device
FDA regulatory strategy
Voluntary standards
FDA guidance
Voluntary standards
Recalls:
Implementation strategy
and Collaboration
Updates (FDA vs. non-FDA updates)
Criteria for corrective and preventive action deemed
recalls
Predictive analytics
Lecture 2: Interoperability
Compatibility by design
Hardware
Software
Labeling
Environment of use
FDA regulation of accessories
Federal Communications Commission (FCC)
regulation
Precautions
Instructions for use
System conguration
Customization
Environment of use
Professional
Home use
www.gcpseminars.com
seminars
Pricing List
GROUP REGISTRATIONS
5 Attendees
Register Here
10+ Attendees
Payment Options:
1. Learning Objectives
2. Participation certificates
3. Interactive sessions with the US expert
4. Post event email assistance to your queries.
www.gcpseminars.com