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List of medical conferences and educations - cme in Palo Alto : 201 results

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Supplier Management with the new Medical Device Regulation EU MDR 745/2017

Ref: 30294 Tuesday August 20th, 2019 - Palo Alto US

Editorial In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or ...

Conference & Seminar: Management

Risk-based Design Control - The New Paradigm for Medical Device Design

Ref: 30293 Tuesday August 20th, 2019 - Palo Alto US

Editorial In this webinar, learn about the 2019 approach to compliant design control, how to create, manage, and maintain the information found in the various Risk Management documents and files. Get insights about how to shrink documentation time to provide enough time for actual risk ...

Conference & Seminar: Hospital

Management of the Data Safety Management Committee for Clinical Trials

Ref: 30292 Wednesday September 18th, 2019 - Palo Alto US

Editorial Join this webinar to receive instructions on the uses of, need for, setup of, and management of a Data Safety Management Committee for an FDA regulated clinical trial.
  Objectives You will gain current, practical knowledge about the responsibilities, functions, and ...

Conference & Seminar: Management

Effective Time Management in Clinical Trials

Ref: 30291 Tuesday September 10th, 2019 - Palo Alto US

Editorial Attend this webinar to learn how to shorten the timeline for key deliverables such as case report form Design, database build, and duration between last patient out and database lock without negatively impacting data quality or putting data integrity at risk.It will cover useful tips ...

Conference & Seminar: Hospital

Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

Ref: 30280 Monday August 26th, 2019 - Palo Alto US

Editorial This Webinar will focus on how to use SMART goals as a framework to draft submission-ready GCP and/or GVP CAPAs that not only adequately address observations but are also practical given your organization’s unique goals and challenges. Anecdotes and examples will be provided to lend co...

Conference & Seminar: Management

FDA's Ambitious Regulation of Social Media

Ref: 30275 Tuesday September 24th, 2019 - Palo Alto US

Editorial FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and ...

Conference & Seminar: Management, Diet & Nutrition

Validation Master Plan - The Unwritten Requirements

Ref: 30274 Wednesday November 20th, 2019 - Palo Alto US

Editorial This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a ...

Conference & Seminar: Management

Powerful Closed-loop CAPA - Meeting FDA Expectations

Ref: 30267 Wednesday November 06th, 2019 - Palo Alto US

Editorial This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just ...

Conference & Seminar: Hospital, Management

US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

Ref: 30266 Wednesday October 23rd, 2019 - Palo Alto US

Editorial Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas ...

Conference & Seminar: Management, Research

EU ISO 13485:2016 Medical Device Quality Management System

Ref: 30265 Wednesday October 02nd, 2019 - Palo Alto US

Editorial Learn the basic overview of the international medical device Quality Management System -- EU’s Quality Management System under ISO 13485:2016. Implementation, training requirements, content and annual internal audit / inspection ...

Conference & Seminar: Management

FDA's Ambitious Regulation of Social Media

Ref: 30264 Tuesday September 24th, 2019 - Palo Alto US

Editorial FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and ...

Conference & Seminar: Management & Taxation

Project Management for FDA-Regulated Companies

Ref: 30263 Wednesday September 18th, 2019 - Palo Alto US

Editorial This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management ...

Conference & Seminar: Management

How to Investigate Environmental Monitoring Excursions

Ref: 30262 Tuesday September 17th, 2019 - Palo Alto US

Editorial This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.   Objectives Medical products are manufactured in ...

Conference & Seminar: Research

Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability

Ref: 30261 Thursday September 12th, 2019 - Palo Alto US

Editorial This training program will list and enumerate relevant laws, regulations and standards required for health equity and patient-centered care of LGBT patients. It will discuss opportunities to collect LGBT–relevant data and information during the healthcare encounter and help chart st...

Conference & Seminar: Management

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

Ref: 30215 Thursday September 12th, 2019 - Palo Alto US

Editorial This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a ...

Conference & Seminar: Pharmacy

Proper Execution of Annual Product Reviews

Ref: 30207 Thursday September 05th, 2019 - Palo Alto US

Editorial This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.   Objectives Annual ...

Conference & Seminar: Management

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

Ref: 30206 Tuesday August 27th, 2019 - Palo Alto US

Editorial This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, ...

Conference & Seminar: Pharmacy

Surviving an FDA Sponsor Inspection - Training for Success

Ref: 30202 Tuesday August 20th, 2019 - Palo Alto US

Editorial This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will ...

Conference & Seminar: Management

Technical Writing in the Pharmaceutical Industry

Ref: 30201 Tuesday August 20th, 2019 - Palo Alto US

Editorial In this webinar, learn how to write technical documents in a highly specialized, highly regulated field like the pharmaceutical industry. It will teach you the techniques that that are easy to understand and help in creating high quality documents with the least amount of ...

Conference & Seminar: Pharmacy

CGMP controlled Raw Materials

Ref: 30200 Thursday August 15th, 2019 - Palo Alto US

Editorial This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, ...

Conference & Seminar: Pharmacy

ICH Q7 FDA Guidance – Its Structure, History, Application and Writer's Intent

Ref: 30199 Thursday August 15th, 2019 - Palo Alto US

Editorial In this webinar attendees will learn the background of all sections of ICH Q7 guidance, key critical section contents, the authors intent when writing critical parts of this guidance and how to apply Q7 in an Active Pharmaceutical Ingredient (API) ...

Conference & Seminar: Pharmacy

The Impact of ICH E6 R2

Ref: 30196 Tuesday August 13th, 2019 - Palo Alto US

Editorial This webinar will discuss the overall impact of the updated GCP ICH E6 (R2) Addendum and what this means for you, your company and selected vendors.   Program Review of ICH E6 R2 Addendum: Why were these changes made? Overall Addendum ...

Conference & Seminar: Research

Current Regulatory Requirements for Sterile Products

Ref: 30195 Tuesday August 13th, 2019 - Palo Alto US

Objectives This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the ...

Conference & Seminar: Management

Orphan Drug Development History & Overview

Ref: 30192 Friday August 09th, 2019 - Palo Alto US

Editorial This program will provide foundational knowledge of orphan drug development, including the history, leading to today’s standards and requirements. You will get an overview of current regulatory and legal requirements. This basis will serve to advance understanding of your role in th...

Conference & Seminar: Pharmacy

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Ref: 30188 Wednesday August 07th, 2019 - Palo Alto US

Editorial This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).   Objectives This webinar describes exactly what ...

Conference & Seminar: Management

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