15

Medical Health courses USA

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  • Course
  • Miami (USA)
  • Different dates available
  • 9h - 2 Quarters
  • Internship
Evaluate laboratory/clinical quality control based

...The following personnel will benefit from the course: Quality Managers Quality Professionals Assay Development Scientists Research Scientists Data Analysts... Learn about: Laboratory results analysis, Quality Training, Medical training... More


Rs 84,191
*Guide price
Original amount in USD:
$ 1,295
  • Course
  • Washington, D. C. (USA)
  • Different dates available
  • 9h - 2 Quarters
  • Internship
Human Factors Methods and Device Product Life

...The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents. Additionally, strategic... Learn about: Device Manufacturers, Pharma / Medical Device, Human Factors... More


Rs 97,193
*Guide price
Original amount in USD:
$ 1,495
Save 15%
  • Training
  • Morrisville (USA)
  • Different dates available
  • 9h - 2 Quarters
  • Internship
Pre-clinical testing and comparability

...Walk through the EU Centralized registration process What to look out for Project management Lecture 4: Market access for Biosimilars HTA in Europe/US... Learn about: Clinical Chemistry, medical Imaging, Regulatory Compliance... More

Special Emagister price

Rs 84,191 Rs 71,188
*Guide price
Original amount in USD:
$ 1,295  $ 1,095
  • Course
  • Miami (USA)
  • Different dates available
  • 2 Days
Express online course

...The following personnel will benefit from the course: Quality Managers Quality Professionals Assay Development Scientists Research Scientists Data Analysts... Learn about: Confidence Training, Medical training, IT risk... More


Rs 84,191
*Guide price
Original amount in USD:
$ 1,295
  • Course
  • Boston (USA)
  • Different dates available
  • 2 Days
Express online course

...These are the learning goals: Reviewing the most significant changes affecting medical device standards and guidance documents Understanding the MDSAP (goals and strategy) Analyzing the MDSAP main differences with standard auditing Understanding grading of MDSAP non-conformances Assessing MDSAP... Learn about: Ms Office, Medical training, IT Auditing... More


Rs 84,191
*Guide price
Original amount in USD:
$ 1,295
  • Course
  • Tukwila (USA)
  • Different dates available
  • 2 Days
Express online course

...Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of... Learn about: Product Development, Risk Management, Medical training... More


Rs 84,191
*Guide price
Original amount in USD:
$ 1,295
  • Course
  • Schiller Park (USA)
  • Different dates available
  • 2 Days
Express online course

..." and just as quickly disappear is the question that the industry is eager to have answered. The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated traditional... Learn about: Marketing Advertising, IT Law, Social Media... More


Rs 84,191
*Guide price
Original amount in USD:
$ 1,295
  • Course
  • San Diego (USA)
  • Different dates available
  • 9h - 2 Days
Express online course

...This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications... Learn about: Communication Skills, Medical training, Device administration... More


Rs 97,193
*Guide price
Original amount in USD:
$ 1,495
  • Course
  • Philadelphia (USA)
  • Different dates available
  • 9h - 2 Quarters
  • Internship
Quality Directors and Managers

...Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate... Learn about: Quality management, IT risk, Medical training... More


Rs 84,191
*Guide price
Original amount in USD:
$ 1,295
Save 15%
  • Course
  • Washington, D. C. (USA)
  • Different dates available
  • 9h - 2 Quarters
  • Internship
Specific documents required for an FDA submission

...When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes... Learn about: Quality Testing, Medical training, IT risk... More

Special Emagister price

Rs 84,191 Rs 71,188
*Guide price
Original amount in USD:
$ 1,295  $ 1,095
  • Course
  • Morrisville (USA)
  • Different dates available
  • 2 Days
Express online course

...This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered... Learn about: Quality Training, Medical training, IT risk... More


Rs 84,191
*Guide price
Original amount in USD:
$ 1,295
  • Event
  • Raleigh (USA)
  • Different dates available
  • 9h - 2 Quarters
  • Internship
Scientific and Engineering / Product Development

.... Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with... Learn about: Product Development, IT Law, Quality Training... More


Rs 84,191
*Guide price
Original amount in USD:
$ 1,295
  • Course
  • Los Angeles (USA)
  • Different dates available
  • 2 Days
Express online course

...The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents. Additionally, strategic... Learn about: Human Factors, Communication Skills, Human Behaviour... More


Rs 84,191
*Guide price
Original amount in USD:
$ 1,295
Save 15%
  • Course
  • Washington, D. C. (USA)
  • Different dates available
  • 9h - 2 Quarters
  • Internship
Quality Professionals

...Gaps and/or incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct... Learn about: Compliance Professionals, Usability training, Product Development... More

Special Emagister price

Rs 84,191 Rs 71,188
*Guide price
Original amount in USD:
$ 1,295  $ 1,095
  • Course
  • Philadelphia (USA)
  • Different dates available
  • 2 Days
Express online course

... Medical Device An Overview of U.S. FDA Medical Device Regulation Regulations for Design and Product Development Premarket Notification - 510(k) and Premarket Approval (PMA) Regulations for Production & Process Control Readiness for FDA Facility Inspection The complex network of multilayer... Learn about: Process Control, Product Development, Medical training... More


Rs 97,193
*Guide price
Original amount in USD:
$ 1,495
  • Course
  • Philadelphia (USA)
  • Different dates available
  • 2 Days
Express online course

... across the product quality lifecycle. According to the Quality System Regulation (QSR) for medical devices, "Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, verifying the acceptability... Learn about: Quality Training, Data analysis, Process Control... More


Rs 84,191
*Guide price
Original amount in USD:
$ 1,295
Save 15%
  • Course
  • Morrisville (USA)
  • Different dates available
  • 2 Days
Express online course

... them. The workshop uses extensive examples and exercises to help clarify the concerns. Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. The EU is not participating... Learn about: Quality Training, Medical training... More


Rs 84,191 Rs 71,188
*Guide price
Original amount in USD:
$ 1,295  $ 1,095
Save 15%
  • Course
  • Schiller Park (USA)
  • Different dates available
  • 9h - 2 Quarters
  • Internship
Quality Management System

... them. The workshop uses extensive examples and exercises to help clarify the concerns. Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. The EU is not participating... Learn about: Manufacturing Technology, Regulatory Compliance, Medical training... More

Special Emagister price

Rs 84,191 Rs 71,188
*Guide price
Original amount in USD:
$ 1,295  $ 1,095