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Liste des conférences et séminaires santé à Palo Alto : 25 résultats

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Technical Writing in the Pharmaceutical Industry

Réf: 30201 Mardi 20 Août 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 ...

Conférence & Séminaire: Pharmacie

Surviving an FDA Sponsor Inspection - Training for Success

Réf: 30202 Mardi 20 Août 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 ...

Conférence & Séminaire: Management

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

Réf: 30293 Mardi 20 Août 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 ...

Conférence & Séminaire: Hôpital

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

Réf: 30294 Mardi 20 Août 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 ...

Conférence & Séminaire: Management

Cdisc Mapping 5: Adam Models - Adsl, Bds and Adae

Réf: 29604 Mercredi 21 Août 2019 - Palo Alto US

Editorial This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide ...

Conférence & Séminaire: Hôpital, Recherche

Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

Réf: 30280 Lundi 26 Août 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...

Conférence & Séminaire: Management

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

Réf: 30206 Mardi 27 Août 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, ...

Conférence & Séminaire: Pharmacie

Proper Execution of Annual Product Reviews

Réf: 30207 Jeudi 05 Septembre 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 ...

Conférence & Séminaire: Management

Effective Time Management in Clinical Trials

Réf: 30291 Mardi 10 Septembre 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 ...

Conférence & Séminaire: Hôpital

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

Réf: 30215 Jeudi 12 Septembre 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 ...

Conférence & Séminaire: Pharmacie

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

Réf: 30261 Jeudi 12 Septembre 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...

Conférence & Séminaire: Management

How to Investigate Environmental Monitoring Excursions

Réf: 30028 Mardi 17 Septembre 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. Program Medical products are manufactured in environments that control the level of ...

Conférence & Séminaire: Recherche, Management

How to Investigate Environmental Monitoring Excursions

Réf: 30262 Mardi 17 Septembre 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 ...

Conférence & Séminaire: Recherche

Cdisc Mapping 5: Adam Models - Adsl, Bds and Adae

Réf: 30027 Mercredi 18 Septembre 2019 - Palo Alto US

Editorial This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide ...

Conférence & Séminaire: Hôpital, Management

Project Management for FDA-Regulated Companies

Réf: 30263 Mercredi 18 Septembre 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 ...

Conférence & Séminaire: Management

Management of the Data Safety Management Committee for Clinical Trials

Réf: 30292 Mercredi 18 Septembre 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 ...

Conférence & Séminaire: Management

FDA's Ambitious Regulation of Social Media

Réf: 30264 Mardi 24 Septembre 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 ...

Conférence & Séminaire: Gestion & Fiscalité

FDA's Ambitious Regulation of Social Media

Réf: 30275 Mardi 24 Septembre 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 ...

Conférence & Séminaire: Management, Diététique & Nutrition

EU ISO 13485:2016 Medical Device Quality Management System

Réf: 30265 Mercredi 02 Octobre 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 ...

Conférence & Séminaire: Management

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

Réf: 30266 Mercredi 23 Octobre 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 ...

Conférence & Séminaire: Management, Recherche

Confidentiality of Substance Use Disorder Patient Records; Complying with the New Federal Law 42 CFR Part 2

Réf: 30029 Lundi 04 Novembre 2019 - Palo Alto US

Editorial This webinar will cover the new law on confidentiality of substance use disorder patient records under 42 CFR part 2. This law was previously known as the confidentiality of drug abuse and alcohol abuse records. The new law was effective in 2017. Anyone or any facility that is ...

Conférence & Séminaire: Management, Hôpital, Infirmiers

Powerful Closed-loop CAPA - Meeting FDA Expectations

Réf: 30267 Mercredi 06 Novembre 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 ...

Conférence & Séminaire: Hôpital, Management

You have a BI Positive or Product Sterility Positive - Now What?

Réf: 30030 Mardi 19 Novembre 2019 - Palo Alto US

Editorial This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause ...

Conférence & Séminaire: Recherche

Validation Master Plan - The Unwritten Requirements

Réf: 30274 Mercredi 20 Novembre 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 ...

Conférence & Séminaire: Management

Contracted Services: Ensuring Compliance with the CMS Hospital CoP Standards, Joint Commission and DNV

Réf: 30031 Lundi 09 Décembre 2019 - Palo Alto US

Editorial This webinar will cover all of the contract requirements for hospitals accredited by the Joint Commission. This standard has been amended every year for the past three years. The CMS telemedicine standard also updated a section in the Joint Commission contract ...

Conférence & Séminaire: Hôpital, Management, Infirmiers