Live Webinar on Optimal Capacity Planning and Resource Allocation for a Portfolio of Clinical Trials by Compliance2go
To become familiar with newest development in optimal capacity planning and resource allocation for a portfolio of clinical trials - June 20, 2013
Live Webinar on Shared Facilities and the Move to Science Based Risk Assessments by Compliance2go
The lecture covers the topic of perception and reality. To be able to show science in risk assessment it has been necessary to design experiments to gather data to allow occurrence to be set in a risk assessment. This use of data has revealed some very interesting anomalies which are discussed. - May 05, 2013
LiveWebinar : 510(k): Format and Contents by compliance2go
This webinar is intended to demonstrate how to prepare a 510(k) in a manner with increased submission quality with awareness for the successful review and clearance. - September 30, 2012
Live Webinar on US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus by Compliance2go
This 90 minute webinar will help you gain a detailed overview of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will help prepare you for regulatory inspections in these countries. Why Should You Attend? This ICH GMP training course will provide your... - August 16, 2012
Live Webinar on FDA Compliant Good Laboratory Practice (GLP) for Drugs, Biologics, Biosimilars and Medical Devices by Compliance2go
This webinar is intended to help you get familiar with the relevant and applicable US regulations, regulatory requirements and guidance necessary for good laboratory practice (GLP) and GLP compliance. - August 02, 2012
Live Webinar on Effective SOP Writing to be FDA Compliant by Compliance2go
Learn and understand the regulatory expectations for, and the proper design and maintenance of effective and compliant Standard Operating Procedures (SOPs). - July 26, 2012
Live Webinar on Best Practices for Complaint Handling in Compliance with FDA and ISO Regulations by Compliance2go
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is... - July 25, 2012
Live Webinar on FDA Regulation of Mobile Medical Apps by Compliance2go
The number of mobile applications or “apps”, including mobile medical apps, is ever increasing and an undeniable mainstay of medicine moving forward. - July 24, 2012
Live Webinar on Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA by Compliance2go
The FDA, with assistance from the FTC, has become increasingly aware of the large amount of dietary supplements that have come onto the market since the passage of the Dietary Supplement Health and Education Act in 1994. A growing public demand for supplements, along with a relatively relaxed... - July 14, 2012
Live Webinar on NAFTA Rules of Origin and Documentation by Compliance2go
Understand how to meet the rules that are required to qualify your imports/exports between the three NAFTA countries (United States, Canada, and Mexico) - July 14, 2012
Live Webinar on Harmonized Tariff Schedule Classification by Compliance2go
The World Customs Organization made its 5 year update to the Harmonized Tariff Schedule (HTS) in 2012 with 220 sets of amendments at the international level. - July 13, 2012
Live Webinar on SOP and FDA Compliance by Compliance2go
Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet there is no guidance on how to write, - July 13, 2012
Live Webinar on Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming, in-process and finished products. Is... - July 12, 2012
Live Webinar on FDA’s Part 11 – Enforcement Trends and Affordable Steps to Take Today by Compliance2go
Since 2010, FDA has embarked on a special enforcement and training of its investigators on 21 CFR 11. - July 12, 2012
Live Webinar on Understanding FDA Expectations for Reusable Medical Devices by Compliance2go
According to FDA, there have been notable advances in recent years in the knowledge and technology related to reprocessing/processing reusable and user-sterilized single use medical devices. - July 12, 2012