Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. Live
Thursday,
May 17, 2012
10:00 AM PDT | 01:00 PM EDT,
Duration:90 Minutes
Water System Biofilm Control and Microbial Monitoring Myths It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? Live
Tuesday,
May 22, 2012
10:00 AM PDT | 01:00 PM EDT,
Duration:90 Minutes
Update on Unique Device Identifier for Device Manufacturers Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions. Live
Tuesday,
May 22, 2012
10:00 AM PDT | 01:00 PM EDT,
Duration:90 Minutes
Hazard Analysis vs. FMECA – Differences and Commonalities The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. Live
Tuesday,
May 22, 2012
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals. Live
Wednesday,
May 23, 2012
10:00 AM PDT | 01:00 PM EDT,
Duration:90 Minutes
Lyophilization Process Development and Cycle Design with a Case Study This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. In the past, a "trial and error" approach was routinely used as the means of cycle design, often resulting in products that were substandard or cycles that were prohibitively long and expensive. Live
Thursday,
May 24, 2012
10:00 AM PDT | 01:00 PM EDT,
Duration:90 Minutes
Validation of Analytical Methods for FDA Compliance: Step-by-Step Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. Live
Thursday,
May 24, 2012
10:00 AM PDT | 01:00 PM EDT,
Duration:75 Minutes
Using Statistics to Determine Sample Size This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered. Live
Tuesday,
May 29, 2012
12:00 PM PDT | 03:00 PM EDT,
Duration:60 Minutes
Risk-Based Monitoring of Clinical Trials: Say Goodbye to 100% Source Document Verify The presentation reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data. Live
Tuesday,
May 29, 2012
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. Recorded
View Anytime
Duration:90 Minutes
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Recorded
View Anytime
Duration:75 Minutes
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Recorded
View Anytime
Duration:60 Minutes
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Recorded
View Anytime
Duration:75 Minutes
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. Recorded
View Anytime
Duration:75 Minutes
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Recorded
View Anytime
Duration:60 Minutes
This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. Recorded
View Anytime
Duration:60 Minutes