Filings Web-based Seminars

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Webinar By GlobalCompliancePanel This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...icial review, resulting in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. Companies are outsourcing more; with some thinking they can also outsource some of their cGMP compliance as well. Thus, the U. S. FDA has indicated that a key area gaining attention is a company's suppliers, for services and products / components.  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...e to comply will result in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area for maintaining cGMP compliance is Change Control. Yet it often is a companya ™s weakest link in compliance - proven by recent high-profile failures. Why so? FDA expectations? How are successful companies meeting this challenge?  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...gulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information being reported and the timeliness. Some at FDA are concerned that  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP's Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical.  more...

Do I E-Shred This This webinar is a primer on handling electronic information. Learn how it's stored (not too technical, I promise!) and where it resides. Learn the 10 privacy principles that form the basis for most privacy legislation and how to use them as part of your or your client's environment. If you or your clients store electronic information, and almost all do, it's critical to include handling  more...