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Upcoming Events

GlobalCompliancePanel

Webinar Special Sale 2017 by GlobalCompliancePanel for just $10

Fremont, CA
Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory complian... read more

Learn how FDA faces constitutional constraints on enforcement decisions

Burlingame, CA
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescript... read more

How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud

Revere, MA
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.
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Past Events

Tougher Import Rules for FDA Imports in 2018 at Raleigh

Tougher Import Rules for FDA Imports in 2018 at Raleigh

Morrisville, NC
Description: FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their...
Thu, Dec 6 2018 9:00 AM Fri, Dec 7 2018 6:00 PM

How to be efficient and compliant with 21 CFR Part 11

How to be efficient and compliant with 21 CFR Part 11

San Diego, CA
Description: This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.It details the requirements for Part 11 and Annex 11: SOP...
Wed, Dec 5 2018 8:00 AM Thu, Dec 6 2018 5:00 PM

Compile a CE Marking Technical File 2018

Compile a CE Marking Technical File 2018

Fremont, CA
Description: Why you should attend Introductions and overview of the EU DirectivesIdentify the EU Directives and standards applicable to your productComply with the implementation details and requirements of the EU MDR & IVDRDesign a new product, or evaluate an existing product, for conformity ...
Thu, Nov 29 2018 9:00 AM Fri, Nov 30 2018 5:00 PM

Excel Spreadsheet Validation 2018 Tools and Techniques

Excel Spreadsheet Validation 2018 Tools and Techniques

Salt Lake City, UT
Description: Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regu...
Thu, Nov 15 2018 9:00 AM Fri, Nov 16 2018 6:00 PM

Introduction to Adaptive Design standard for clinical research

Introduction to Adaptive Design standard for clinical research

Philadelphia, PA
Description: This 2-day seminar includes an overview of Adaptive Design, and an emphasis in group sequential design, sample size re-estimation, and Phase II/III Adaptive Seamless Designs. The role of statistics in clinical trials incorporates the tools used to develop a robust study, minimize b...
Thu, Nov 15 2018 9:00 AM Fri, Nov 16 2018 6:00 PM

Clear, Complete, Step-by-Step

Clear, Complete, Step-by-Step

San Diego, CA
Description: Organizations of all types and sizes continue to struggle needlessly with HIPAA Compliance. For example, HIPAA Risk Analysis – Risk Management is the basis of the HIPAA Compliance Program of every Covered Entity and Business Associate. But mandatory HIPAA Compliance Audits conducted...
Mon, Nov 12 2018 9:00 AM Tue, Nov 13 2018 6:00 PM

Essential Techniques for Medical Devices

Essential Techniques for Medical Devices

San Diego, CA
Description: Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This two-day seminar will help you...
Mon, Nov 12 2018 9:00 AM Tue, Nov 13 2018 6:00 PM

OSHA Recordkeeping and Surviving an OSHA Audit

OSHA Recordkeeping and Surviving an OSHA Audit

New Orleans, LA
Description: The Occupational Safety and Health Administration (OSHA) has jurisdiction to protect the workers of America and its territories from harmful working conditions. They are a department under the US Department of Labor and was given the legal authority to create standards to regulate m...
Thu, Nov 8 2018 8:30 AM Fri, Nov 9 2018 4:30 PM

Applied Statistics for Scientists and Engineers seminar at Boston

Applied Statistics for Scientists and Engineers seminar at Boston

Revere, MA
Description: Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stab...
Mon, Nov 5 2018 9:00 AM Tue, Nov 6 2018 6:00 PM

HIPAA 2018 - Staying Competitive and Complying with HIPAA

HIPAA 2018 - Staying Competitive and Complying with HIPAA

Salt Lake City, UT
Overview: In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Compliance. Staying up to date on the newest health care information and acquiring new patients takes time. ...
Mon, Oct 29 2018 9:00 AM Tue, Oct 30 2018 6:00 PM

Mailing Address

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
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