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    Live Webinar Analytical method validation

    Ref: 27014 Monday April 23rd, 2018 - Online

    Live Webinar Analytical method validation   Description Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods
    Many analytical methods, ...

    Education: Pharmacy

    Label Promotion of Drugs and Medical Devices

    Ref: 26604 Tuesday April 24th, 2018 - Online

    Overview: This session sets the context for the off-label promotion of medical    products starting with early history and moving to the most recent history    of FDA's decision on guidance documents.   Why should you Attend: This class presents the latest ...

    Education: Pharmacy, For the general public

    Live webinar: U.S. Export Documentation and Procedures

    Ref: 27025 Tuesday April 24th, 2018 - Online

    Live webinar: U.S. Export Documentation and Procedures       Description This webinar will assist U.S. companies who export goods around the world to understand the Bureau of Industry and Security U.S. export procedures and regulations and the Foreign Trade Regulations ...

    Education: Pharmacy

    Live Webinar Successful FDA Meeting Preparation and Conduct

    Ref: 27015 Wednesday April 25th, 2018 - Online

    Live Webinar Successful FDA Meeting Preparation and Conduct     Description The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting.  However, the guidance tend to be general and ...

    Education: Pharmacy

    How to Comply with 21 CFR 11 Requirements

    Ref: 26773 Wednesday May 02nd, 2018 - Online

    What are future expectations for EMRs (FDA Draft Guidance) and the impact on sponsors and sites.

    Education: Pharmacy, Management, National Health

    Live Webinar FDA Compliance and Mobile Applications

    Ref: 27022 Wednesday May 02nd, 2018 - Online

                    Live Webinar FDA Compliance and Mobile Applications     Description Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and ...

    Education: Pharmacy

    FDA 21 CFR Part 11 Compliance - Validation Seminar 2018

    Ref: 26911 05/03/2018 -> 05/04/2018 - Zurich DE

      Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-...

    Education: Biology, Pharmacy

    HIPAA Security 2018 and Beyond - HIPAA Denver Seminars

    Ref: 26912 05/03/2018 -> 05/04/2018 - Denver US

      Overview: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any ...

    Education: Medicine, Pharmacy

    Does your CAPA Program Need a CAPA | Seminar CAPA 2018

    Ref: 26913 05/03/2018 -> 05/04/2018 - Las Vegas US

      Course "Death by CAPA - Does your CAPA Program need a CAPA?" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-day seminar will help you establish an efficient and effective CAPA ...

    Education: Medicine, Pharmacy

    Risk Management Standard in Medical Devices Seminar 2018

    Ref: 26914 05/03/2018 -> 05/04/2018 - Denver US

      Course "Risk Management in Medical Devices Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Gaps, incorrect or incomplete implementation of software can delay or make the ...

    Education: Medicine, Pharmacy

    Fundamentals of Risk Management in Clinical Research 2018

    Ref: 26774 Friday May 04th, 2018 - Online

    Practical aspects of developing key performance and quality indicators at all stages of clinical trials will be discussed.

    Education: Pharmacy, Management, National Health

    Computer Systems Validation Conference 2018 - 21 CFR Part11 Compliance

    Ref: 26915 05/07/2018 -> 05/08/2018 - Switzerland US

      Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-...

    Education: Medicine, Pharmacy

    Ten-Step Process for COTS Risk-Based CSV | Course 2018

    Ref: 26916 Tuesday May 08th, 2018 - Salt Lake City US

      Course "How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This interactive two-day course explores proven ...

    Education: Medicine, Pharmacy

    Live Webinar Understanding and Applying the New EU Medical Device Regulations (EMDR)

    Ref: 27023 Tuesday May 08th, 2018 - Online

    Live Webinar Understanding and Applying the New EU Medical Device Regulations (EMDR)     Description The European Parliament just adopted the Medical Devices (MDR) and In vitro Diagnostic Medical Devices (IVDR) regulations. The adoption marks another hallmark event in the global ...

    Education: Pharmacy

    3 hrs Webinar - Tools for Human Error Reduction: Developing Metrics and KPI's (Key Performance Indicators) to minimize Human error rates

    Ref: 27024 Tuesday May 08th, 2018 - Online

    3 hrs Webinar - Tools for Human Error Reduction: Developing Metrics and KPI's (Key Performance Indicators) to minimize Human error rates       Description Human error is known to be the primary cause of quality and production losses in many industries. Although it is ...

    Education: Pharmacy

    Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485

    Ref: 27010 Wednesday May 09th, 2018 - Online

    Live webinar Good Clinical Practices: Regulations and Compliance     Description Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research ...

    Education: Pharmacy

    Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485

    Ref: 27021 Wednesday May 09th, 2018 - Online

        Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485     Description The FDA CGMPs (21 CFR 820.30) and ISO QMS’ (ISO 13485:2016 7.3) expect companies to perform meaningful, results driven Design Control activities as defined in the regulations / st...

    Education: Pharmacy

    Training for Small Healthcare Providers | HIPAA Seminar 2018

    Ref: 26917 05/10/2018 -> 05/11/2018 - Ut US

      Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a ...

    Education: Medicine, Pharmacy

    Phase I Investigational Drug Products | USA Seminar 2018

    Ref: 26918 05/10/2018 -> 05/11/2018 - Salt Lake City US

      Course "Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?" has been pre-approved by RAPS as eligible for up to 12 credits towards a ...

    Education: Medicine, Pharmacy

    Biostatistics for Non-Statistician | Salt Lake City Seminar 2018

    Ref: 26919 05/10/2018 -> 05/11/2018 - Salt Lake City US

      Course "Biostatistics for the Non-Statistician" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.   Why should you attend: Statistics is a useful decision making tool in the clinical research arena. ...

    Education: Pharmacy, Medicine

    ISO 13485:2016 Implementation Workshop | Conference 2018

    Ref: 26920 05/10/2018 -> 05/11/2018 - Ut US

      Course "ISO 13485:2016 Implementation Workshop" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The medical device industry is in the midst of major change, with the publication of the FDA's ...

    Education: Medicine, Pharmacy

    2 Day Workshop: Human Error: Why Human Error is the biggest downtime problem in the manufacturing sector and how to investigate, control, ...

    Ref: 27106 05/10/2018 -> 05/11/2018 - , Usa US

    2 Day Workshop: Human Error: Why Human Error is the biggest downtime problem in the manufacturing sector and how to investigate, control, reduce, and prevent to improve results    Description Small mistakes can lead to big disasters—just ask the scientists and engineers who worked ...

    Education: Pharmacy

    C-TPAT - Trade Partnership Against Terrorism 2018

    Ref: 26775 Monday May 14th, 2018 - Online

    How to develop a standard approach to complying with the voluntary C-TPAT guidelines, and Strategies for reducing the cost and complexity of compliance with C-TPAT.

    Education: Pharmacy, Bio-Technologies, Management, National Health

    Combination Products Regulations Course | USA & EU Seminar 2018

    Ref: 26921 05/15/2018 -> 05/16/2018 - Switzerland US

      Course "Combination Products Regulations: Drug and Device Combinations in the USA and EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This seminar provides Professionals working in this ...

    Education: Medicine, Pharmacy

    Live Webinar NAFTA Rules of Origin and Documentation (with Updates on Renegotiations)

    Ref: 27026 Tuesday May 15th, 2018 - Online

    Live Webinar NAFTA Rules of Origin and Documentation (with Updates on Renegotiations)     Description NAFTA is the largest free trade agreement between the United States, Mexico, and Canada. The NAFTA provides for the entry of goods duty-free into each of the countries provided ...

    Education: Pharmacy

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