Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

We all want to have a great generic portfolio, but all our competitors also want the same thing - so how do you make sure that you get the winners to market before they do? Do you go for supergenerics, OTCs, smaller volume niches that you can exploit at higher prices - or should you stick to higher volume staples even though margins might be tight? The webinar looks at product selection and who else in the organisation you need to involve to ensure that you get there on time – is it regulatory? production planning? purchasing? strategic planners? The answer is – all of them!

As far as biosimilars are concerned, Europe led the way and the rest of the world, including the US, followed - but how did this happen? The webinar will explain how Europe’s EMA developed the first regulatory environment that allowed multiple competitors to enter the market and start to take market share away from the originators. It also looks at the effect of the increased competition, the moves to include biosimilars in tenders, the resultant impact on prices, how the originators fought back and where we are now.

This webinar will provide an overview of FDA and Health Canada, their organizational structure, regulatory and compliance oversight, agency interactions and implications for your organization and your regulatory and compliance obligations.

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.

This Water system compliance training/webinar 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.

This Water system compliance training will guide you through the changes to implement to Validate Water system and better understanding of quality specifications and process control levels, as well as the microbiology of water systems.

This Objectionable Microorganism training will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

This JPAL (Japanese Pharmaceutical Affairs Law) training will go into the unique post-market challenge of change management facing the Foreign Manufacturer when dealing with its MAH counterpart in Japan.

This Microbiology training/webinar will provide a new approach in ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities.

This JPAL (Japanese Pharmaceutical Affairs Law) QMS training/webinar will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.

This JPAL training will describe requirements, common mistakes & best practices while dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder).

This Water System Compliance training will review what biofilm is and how it grows and will cover how it affects just about every kind of unit operation used in today's water systems.

This JPAL training will emphasize on Japanese Pharmaceutical Affairs law with respect to - Classification, device approvals, clinical data, MAH (Marketing Authorization Holder),foreign manufacturer accreditation,QMS,post-market complaints & vigilance

This FDA audit training will review the fundamental aspects of auditing biopharmaceutical API facilities to ensure their compliance with current regulatory guidelines.

This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication. One of the most common inspection findings is a failure by the Investigator "…to conduct the studies or ensure they were conducted according to the investigational plans". Often, the citation isn't just that the protocol wasn't followed but that documentation surrounding management of the issue is insufficient. Therefore, Sponsors are well served by having an effective process to identify, document, and communicate departures from the investigational plan. This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication.

This Pharmaceutical compliance training will provide instruction on how to establish and maintain a Maintenance & Calibration program for pharmaceutical instrumentation & equipment.

This Biotech training will provide valuable assistance to all regulated companies that need to investigate product issues.

This Quality management training will review processes for integrating a reasonable level of risk management into the quality management system.