Subscribe to Events Feeds

225 Results Found

A Design Control Primer
8/13/2014 10:00 AM - 11:00 AM
Online Event Fremont, California United States
Event Listing
Summary:

This webinar will cover the basics of design controls, and provide recommendations for implementation of a compliant design control system. Also discussed will be deisgn control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well.

Customer Interactions Law Policies Ethics
8/6/2014 10:00 AM - 11:00 AM
Online Event Fremont, California United States
Event Listing
Summary:

The proliferation of legal requirements (law and regulation) governing the financial relationships between medical product companies and the doctors who order their products has led to what can only be described as a tangled mess. Many device companies have had to add personnel, or employ expensive consultants in order to have a hope of complying.

Excel Spreadsheet Validation for FDA 21 CFR Part 11
8/12/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
Event Listing
Summary:

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

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
Event Listing
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
Event Listing
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
Event Listing
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
Event Listing
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.

Events Map