John E Lincoln Wednesday
20 February
, 2019
, 2019
10:00 AM PST | 01:00 PM EST
duration 90 Minutes
John E Lincoln
¤150.00
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

Angela Bazigos Wednesday
20 February
, 2019
, 2019
10:00 AM PST | 01:00 PM EST
duration 90 Minutes
Angela Bazigos
¤150.00
European Data Protection Regulation - Latest
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

John N. Zorich Wednesday
20 February
, 2019
, 2019
10:00 AM PST | 01:00 PM EST
duration 90 Minutes
John N. Zorich
¤150.00
Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Jose Mora Wednesday
20 February
, 2019
, 2019
10:00 AM PST | 01:00 PM EST
duration 90 Minutes
Jose Mora
¤150.00
Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration
The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries.

John C. Fetzer Thursday
21 February
, 2019
, 2019
10:00 AM PST | 01:00 PM EST
duration 60 Minutes
John C. Fetzer
¤150.00
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.

Salma Michor Thursday
21 February
, 2019
, 2019
10:00 AM PST | 01:00 PM EST
duration 60 Minutes
Salma Michor
¤150.00
The New EU Medical Device Regulation
Regulation proposals of the European Commission

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John Ryan
Recorded
View Anytime
¤190.00
John Ryan
Artificial Intelligence (AI) in the Food Supply Chain - Current and Future Potential
From robotic planting and harvesting systems through self-driving trucks, inspection systems, traceability, robotic pick and place loading systems, robotic grading systems, food processing systems, pick and place, inventory control and other areas, Artificial Intelligence (AI) is planning major changes that will impact the food supply chain in ways we can only imagine.

Ginette Collazo
Recorded
View Anytime
¤190.00
Ginette Collazo
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
This training program will offer attendees an understanding of human error, its factors and causes.

Steven Wachs
Recorded
View Anytime
¤190.00
Steven Wachs
Statistical Hypothesis Tests: Concepts and Applications
This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes.

Steven Wachs
Recorded
View Anytime
¤190.00
Steven Wachs
Fractional Factorial Experiments for Screening Studies
In this webinar attendees will learn the key concepts behind Design of Experiments (DOE) and the use of DOE for Process and Product Optimization.

Steven Wachs
Recorded
View Anytime
¤190.00
Steven Wachs
Estimating Reliability Performance with Accelerated Life Tests
This webinar on Estimating Reliability Performance of products will show how you can use Accelerated Life Testing methods (ALT) to reduce costs, minimize risks and ensure adequate product performance prior to launch.

Joy McElroy
Recorded
View Anytime
¤190.00
Joy McElroy
Writing Validation Master Plans; Best Practices for Writing a Compliant Document
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs.

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