Similar Events |
FL: 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 management of a product in the pharmaceutical, biotechnology, medical device, tobacc
Date Posted: 26-Apr-18
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Houston: FDA?s New Endotoxin Test Guidance for Human Parenteral Drugs, Biologic
DESCRIPTION
Topic Background:
FDA current thinking regarding Endotoxin testing has changed. Industry needs to adopt this new thinking in order to prevent observations, which lead to further scrutiny by the agency.
Description:
The curren
Date Posted: 15-Apr-16
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Houston: Current Regulatory and Compliance Trends in the Area of Consent Decree
DESCRIPTION
Topic Background:
Many Years Ago Schering Plough underwent the first Consent Decree.
Since, then many years elapsed and the term Consent Decree was foreign to many employees and employers and to Industry overall.
Over the last Sev
Date Posted: 18-Feb-16
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Houston: Preparing for Regulatory Audits by Carlson E. Patterson
DESCRIPTION
This seminar will provide an overview of water systems used for pharmaceutical manufacturing. We will cover validation, monitoring, and analyzing data results. What data collected means, how excursions should be handled, and what acti
Date Posted: 15-Apr-16
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Houston: Proper CAPA Management by Danielle DeLucy
DESCRIPTION
In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal
Date Posted: 18-Apr-16
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DC / U.S. Capitol : 2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018
Description
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customiz
Date Posted: 17-May-18
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DC / U.S. Capitol : 2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018
Location 1: Washington DC
Jun 28 - 29
Description
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including wides
Date Posted: 04-May-18
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FL: 3-hrs Webinar-Deciding When to Submit a 510(k)
3-hrs Webinar-Deciding When to Submit a 510(k) for a Change to an Existing Device – FDA’s Final Guidance
Description
A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is about to b
Date Posted: 11-May-18
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FL: 3-hrs Webinar-Deciding When to Submit a 510(k) for a Change to an Exis
3-hrs Webinar-Deciding When to Submit a 510(k) for a Change to an Existing Device – FDA’s Final Guidance
Description
A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is about to be
Date Posted: 30-Apr-18
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Oakville: Excusive (No Cost) FEA/CFD Simulation Seminar for Designers/CAD Users
re you a Designer/Drafting Professional/CAD User/Technologist? Are you little hesitant to do Design Validation/Simulation? and do you often ask yourself these questions :
•Will I be able to do simulation to test designs without prior experience?
Date Posted: 16-Jul-13
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DC / U.S. Capitol : 2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018
Location 1: Washington DC
Jun 28 - 29
Description
GxP records generated by spreadsheet calculations are electronic records and should comply with FDA’s 21 CF
Date Posted: 21-May-18
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Houston: Understanding the Regulatory Requirements for the Over the Counter
DESCRIPTION
The US FDA?s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs.
To introduce OTC (nonprescription) drug products into the U.
Date Posted: 15-Apr-16
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FL: 3-hrs Virtual Training 2018 Latest FDA thinking on deciding when
3-hrs Virtual Training 2018 Latest FDA thinking on deciding when to Submit a 510(k) for a Change to an Existing Device – FDA’s Final Guidance
Description
A premarket notification (510(k)) is required when a legally marketed device subject
Date Posted: 31-May-18
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Houston: Hypothesis Testing for Means ? A Practical Approach
DESCRIPTION
One common statistical technique, especially useful in quality engineering and manufacturing, is the hypothesis test. While it is common, it can be confusing and not well understood. In addition, some instances can involve complicated
Date Posted: 18-Apr-16
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Houston: Introduction to Risk Management: Medical Devices
DESCRIPTION
This webinar will cover Risk Management per ISO 14971 throughout the product lifecycle. Risk Management is an important process to methodically and effectively identifying and mitigating risks in the product design and manufacturing p
Date Posted: 18-Apr-16
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