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List of medicine conferences and seminars in Palo Alto : 24 results

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Medicine conference and seminar in Palo Alto

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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

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

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

Ref: 29604 Wednesday August 21st, 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 ...

Conference & Seminar: Hospital, Research

Health Canada Medical Device Regulations (SOR/98-202)

Ref: 30304 Thursday August 22nd, 2019 - Palo Alto US

Editorial Attend this webinar to get an overview of the Health Canada Medical Devices Regulations and its requirements. Also, get guidance on how to approach MDEL and Device Licensing, Renewals and Costs. Objectives Want to sell your device in Canada but don’t know how? Unsure if you ...

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

State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs

Ref: 30305 Tuesday August 27th, 2019 - Palo Alto US

Editorial This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-...

Conference & Seminar: Hospital

State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs

Ref: 30307 Tuesday August 27th, 2019 - Palo Alto US

Editorial
This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a ...

Conference & Seminar: Management

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?

Ref: 30309 Wednesday August 28th, 2019 - Palo Alto US

Editorial
This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2012 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device ...

Conference & Seminar: Hospital

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

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

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

How to Investigate Environmental Monitoring Excursions

Ref: 30028 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. Program Medical products are manufactured in environments that control the level of ...

Conference & Seminar: Research, 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

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

Ref: 30027 Wednesday September 18th, 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 ...

Conference & Seminar: Hospital, Management

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

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

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

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

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

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

Ref: 30029 Monday November 04th, 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 ...

Conference & Seminar: Management, Hospital, Nurses

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

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

Ref: 30030 Tuesday November 19th, 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 ...

Conference & Seminar: Research

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

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

Ref: 30031 Monday December 09th, 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 ...

Conference & Seminar: Hospital, Management, Nurses