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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
8/27/2014 10:00 AM - 11:00 AM
Online Event Fremont, California United States
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Summary:

During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.

ICH GCPs and the Clinical Research Process Including Phase 0123 and Phase 4 trials
8/12/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
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Summary:

This webinar presents a comprehensive overview of the ICH GCP and other clinical requirements for conducting clinical trials. Learn about the ICH GCP, use of the ICH GCP during clinical trials and the general concepts upon which clinical trials are based. This webinar allows clinical professionals to prepare for and conduct clinical trials.

Key Concepts in Successful Water System Sanitization
8/5/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
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Summary:

This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches, but also be able to recognize the early symptoms of a sanitization failure and troubleshoot the process for better optimization.

Measurement Uncertainty in Microbiology
8/18/2014 11:00 AM - 11:00 AM
Online Event Fremont, California United States
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Summary:

Many microbiology laboratories are confused about what MU is, how to calculate it and how to apply it. We will discuss what is needed to meet the accreditation requirement for MU, including, what data to collect and how to analyze it. Also a practical step by step approach to data compilation specifically applicable to microbiology will be discussed.

Quality Management Systems Creating Implementing and Improving
8/14/2014 10:00 AM - 11:00 AM
Online Event Fremont, California United States
Event Listing
Summary:

All parts of the Pharmaceutical Quality System should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s). The basic concepts of Quality Management, Good Manufacturing Practice and Quality Risk Management are inter-related.

The Most Common Problems with Software Validation Processes
8/20/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
Event Listing
Summary:

This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.

Understanding Combination Products Requests for Designation and Product Jurisdiction
8/14/2014 10:00 AM - 11:00 AM
Online Event Fremont, California United States
Event Listing
Summary:

This webinar will provide a detailed discussion of understanding the definition of a combination product, the categories of combination products, how combination products are reviewed, how to assemble a request for designation (RFD) and how to work with FDA when submitting applications for combination products. To do this it will reference the extensive information provided by FDA's Office of Combination Products.

Marketing Made Lean
9/3/2014 1:00 PM - 9/24/2014 5:00 PM
FVTC Waupaca Regional Center Waupaca United States
Event Listing
Summary:

The FVTC Venture Center Team has developed a 4-part, 16 hour workshop series, Marketing Made Lean for micro and small businesses.Marketing Made Lean will enable you to gain and retain customers while increasing sales and profit.

Eseed Entrepreneurship Training
9/10/2014 6:00 AM - 12/8/2014 9:00 AM
FVTC Waupaca Regional Center Waupaca United States
Event Listing
Summary:

E-seed™ provides practical tools to prepare a business plan that can be applied immediately to your start-up or existing business. Gain awareness and expand your entrepreneurial and small business skills with these hands-on and interactive series.

Marketing Made Lean
9/4/2014 1:00 PM - 9/25/2014 5:00 PM
FVTC Oshkosh Riverside Campus Oshkosh United States
Event Listing
Summary:

The FVTC Venture Center Team has developed a 4-part, 16 hour workshop series, Marketing Made Lean for micro and small businesses. Marketing Made Lean will enable you to gain and retain customers while increasing sales and profit.

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