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What are future expectations for EMRs (FDA Draft Guidance) and the impact on sponsors and sites.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

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

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

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

Root Cause Analysis: Foundation of Investigations and CAPA

Ref: 26922 05/16/2018 -> 05/17/2018 - Philadelphia US

  Course "Root Cause Analysis: Foundation of Investigations and CAPA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Why you should attend: What do the regulations say? Four Phases of ...

Education: Medicine, Pharmacy

New EU Medical Device Regulation | Updated Regulation 2018

Ref: 26923 05/17/2018 -> 05/18/2018 - Switzerland US

  Course "The New EU Medical Device regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.   Overview: Regulation proposals of the European Commission Background In 2012, the Commission ...

Education: Medicine, Pharmacy

Promotion & Advertising Practices 2018 under FDA Observation

Ref: 26924 05/17/2018 -> 05/18/2018 - Philadelphia US

  Course "FDA Scrutiny of Promotion and Advertising Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: If you go "off label" with advertising and promotion, FDA's hammer can hit hard and ...

Education: Medicine, Pharmacy

Process Validation General Principle and Practices - Philadelphia 2018

Ref: 26925 05/17/2018 -> 05/18/2018 - Philadelphia US

  Course "Applied Statistics for FDA Process Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In Guidance for Industry Process Validation: General Principle and ...

Education: Medicine, Pharmacy

Clinical Data Management - Benefits of Standardization in Establishing CDM Processes

Ref: 26931 05/17/2018 -> 05/18/2018 - Philadelphia US

  Course "Clinical Data Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: When new drugs or devices are tested in humans, the data generated by, and related to, these trials is known ...

Education: Medicine, Pharmacy

Investigator Reporting Responsibilities - OHRP

Ref: 26776 Friday May 18th, 2018 - Online

A comparison will be provided for the AE reporting requirements for drugs and devices.

Education: Pharmacy, Bio-Technologies, Management

Manufacturing Safety - What you don't Know can Harm you

Ref: 26777 Friday May 18th, 2018 - Online

In this webinar, we will explore the hazards related to the manufacturing facility on many fronts.

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

Managerial Success Practices 2018 | Making Leadership 2018

Ref: 26926 05/21/2018 -> 05/22/2018 - Boston, MA US

  Overview: Inspire and influence your team members to achieve your goals as a team! Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation.. apply a consistent theory in ...

Education: Medicine, Pharmacy

Drug Substances and Drug Products - Specifications

Ref: 26778 Wednesday May 23rd, 2018 - Online

Learn requirements for changing specifiations through the lifestyle of the product.

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

A Risk Based Approach to IT Infrastructure Seminar 2018

Ref: 26928 05/24/2018 -> 05/25/2018 - Minneapolis, MN US

  Course "A Risk Based Approach To IT Infrastructure & Cloud Qualification, Compliance & Control" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: GxP Regulated companies are dependent on ...

Education: Pharmacy, Medicine

Learning Management Systems | LMS Seminar 2018

Ref: 27093 06/04/2018 -> 06/05/2018 - Seattle US

Course "Learning Management Systems (LMS)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will describe the development of job position curricula in the pharmaceutical industry using a ...

Education: Medicine, Pharmacy

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