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Upcoming Events

Compliance4all

Turn a Culture of Quality Into a Competitive Advantage

Fremont, CA
Overview:A culture of quality is a powerful tool for creating an effective and efficient Quality Management System. A culture of quality is not accidental but can be purposefully nurtured and developed.

Quality Risk Management Overview 2019

Fremont, CA
Overview:Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM.Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is use... read more

Quality Control for Microbiological Media and Reagents

Fremont, CA
Overview:This webinar will help you develop a quality control program that fits your microbiological laboratory's needs. We will explicitly not cover any serological, immunological or molecular tests.

Architect and Implement Solution 2019

Fremont, CA
Overview:We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization.

Statistical Hypothesis Tests: Concepts and Applications

Fremont, CA
Overview: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 sampl... read more

How to Create a Medical Software Development File - ISO 6230

Fremont, CA
Overview:You will learn, how to apply the ISO 62304 in the medical software development process and how to create a medical software development file.

Third-Party Sender Registration - Are you in Compliance?

Fremont, CA
Overview:The ODFI is responsible for the registration process for any Third-Party Senders and nested TPS; registration is also necessary even if there is no TPS relationship.

FDA's Quality Metrics - Latest Advances

Fremont, CA
Overview:This is a very important webinar for the FDA who is planning to use the quality metrics as part of their risk based inspection process.

How to conduct a Compliance Gap Analysis for ERM

Fremont, CA
Overview:This webinar will explain how to conduct a compliance gap analysis for Enterprise Risk Management (ERM). Attendees will learn best practices to ensure ERM compliance.

Overcoming Obstacles of the Canadian Drug Regulatory Landscape

Fremont, CA
Overview:Through this presentation, you will develop a comprehensive understanding of the Drug Approval Process and in parallel examine major misconceptions and misunderstandings.

Annual ACH Rules Compliance Audit- a Step-by-Step Guide

Fremont, CA
Overview:The NACHA Operating Rules and Guidelines require that all participating depository financial institutions, third-party senders and third-party service providers that provide ACH services conduct an annual ACH audi... read more
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Past Events

Controlled Document System for a Life Sciences Manufacturing Plant

Controlled Document System for a Life Sciences Manufacturing Plant

Fremont, CA
Overview:Life science manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained b...
Thursday, April 18 2019 10:00 AM 11:00 AM

How to Implement MDSAP Requirements into your ISO 1348

How to Implement MDSAP Requirements into your ISO 1348

Fremont, CA
Overview:How a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working. Why should you Attend:Your implementation time should be short and need smart ideas to reach the ...
Monday, April 15 2019 10:00 AM 11:30 AM

Data Integrity: Compliance with 21 CFR Part 11

Data Integrity: Compliance with 21 CFR Part 11

Fremont, CA
Overview:This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. Areas Covered in the Session:What 21 CFR Part 11 means todayPurpose of Part 11What does Part 11 mean?SOPsSystem featuresInfrastruct...
Thursday, April 11 2019 10:00 AM 11:30 AM

Strategies To Prevent Manufacture And Distribution Of Substandard Medications

Strategies To Prevent Manufacture And Distribution Of Substandard Medications

Fremont, CA
Overview:In this webinar we will provide you with best practices that have been proven effective, and equip you with the means to advocate for these ideas within your organization. Why should you Attend:If a legitimate product is not manufactured according to quality standards or becomes degrade...
Wednesday, April 10 2019 10:00 AM 11:30 AM

FDA's New Import Program for 2019

FDA's New Import Program for 2019

Fremont, CA
Overview:In this interactive session author will discuss about the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS). Why should you Attend:The new import entry filing requirements became effective in 2016 and are posing pr...
Tuesday, April 9 2019 10:00 AM 11:00 AM

Best Mastering Excel Formulas and Functions 2019

Best Mastering Excel Formulas and Functions 2019

Fremont, CA
Overview:Functions are built-in formulas that have been programmed to perform a specific calculation. They range from the simple such as SUM and AVERAGE (used to calculate the total and average of numbers in a range of cells) to the powerful IF and VLOOKUP.  Why should you Attend:How to create f...
Monday, April 8 2019 9:00 AM 12:00 PM

Test Method Validation to Verify the Performance of a Medical Device

Test Method Validation to Verify the Performance of a Medical Device

Fremont, CA
Overview:Those who work with process optimization and validation focus on optimizing a process and reducing variability. Those working on Test Method Validation, on the other hand, focus on discerning between process variation and measurement error from the test method itself. Why should you Att...
Thursday, April 4 2019 10:00 AM 11:30 AM

FDA's 21 CFR Part 11 for US jurisdictions and Eudralex

FDA's 21 CFR Part 11 for US jurisdictions and Eudralex

Fremont, CA
Overview:These electronic records must be maintained according to regulatory requirements contained within FDA's 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions. Why should you Attend:Attendees will learn how to review audit trails, using a risk based appr...
Wednesday, April 3 2019 10:00 AM 11:30 AM

Supply Chain Traceability is Going Digital [What You Can Do to Prepare]

Supply Chain Traceability is Going Digital [What You Can Do to Prepare]

Fremont, CA
Overview:Recall requires traceability data that tells what food is in the stream, where it is located and recall systems must be able to provide such information in real time. Reducing recall time means reducing illness, the loss of life and damage to the industry's reputation. Why should you At...
Wednesday, April 3 2019 10:00 AM 11:15 AM

Compliance with the New ICH GCP Revision 2 Addendum

Compliance with the New ICH GCP Revision 2 Addendum

Fremont, CA
Overview:This will enable you to meet the new international GCP standard to ensure regulatory compliance and the acceptance of clinical trial data by the regulatory authorities internationally. Why should you Attend:With the new ICH GCP E6 Revision 2 Addendum now finalised the changes should hav...
Monday, April 1 2019 10:00 AM 11:00 AM
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