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List of medicine events in Palo Alto : 19 results

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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

The Regulation of in-house IVDs and accreditation of laboratory users in Australia

Ref: 30337 Wednesday September 25th, 2019 - Palo Alto US

Editorial Attend this webinar to understand the definitions of in-house IVDs, the regulatory requirements including classification & essential principles, the NATA requirements related to how and when IVDs can be used as a research or diagnostic tool and the current laboratory supervision ...

Conference & Seminar: Hospital

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

EU ISO 13485:2016 Medical Device Quality Management System

Ref: 30328 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 expectations.
  Objectives In the U. S., the ...

Conference & Seminar: Management

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, ...

Ref: 30326 Tuesday October 08th, 2019 - Palo Alto US

Editorial This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device ...

Conference & Seminar: Management

Root Cause Analysis - The Heart of Corrective Action

Ref: 30329 Tuesday October 08th, 2019 - Palo Alto US

Editorial This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis. Objectives Reviewing CAPA The difference between Correction, Corrective Action and Preventive ...

Conference & Seminar: Management

Recognizing and Responding to "Red Flags" in Clinical Operations

Ref: 30418 Tuesday October 08th, 2019 - Palo Alto US

Editorial Sponsors need to comply with various legal requirements for drug product development. These include communications with Federal and State Regulatory agencies. The post-marketing requirements include more functional areas of the company such as sales and marketing, medical affairs, and ...

Conference & Seminar: Hospital

Compliance Rules and Regulations for Hospital RN Case Managers, Social Work Case Managers, Case Management Leaders and Physician Advisors: ...

Ref: 30346 Wednesday October 09th, 2019 - Palo Alto US

Editorial This webinar will review the compliance issues that most greatly impact on your practice such as the 2-midnight rule, the NOTICE Act, HINNs, and many others. It will help you to identify where you may have compliance practice gaps as well as how to fix ...

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

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

Ref: 30330 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 of ...

Conference & Seminar: Management

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

Powerful Closed-loop CAPA - Meeting FDA Expectations

Ref: 30334 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: 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

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

Ref: 30335 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 and ...

Conference & Seminar: Hospital

Best Practices for an Effective Cleaning Validation Program

Ref: 30384 Tuesday November 19th, 2019 - Palo Alto US

Editorial This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory ...

Conference & Seminar: Hospital

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