Apr 12, 2011
Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing.
Apr 11, 2011
This webinar will address these complexities and break them down into their simple elements. Then these elements will be rebuilt into a practical system that will enhance understanding of the requirements.
Apr 11, 2011
CAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM.
Apr 11, 2011
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
Apr 08, 2011
Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
Apr 08, 2011
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
Apr 07, 2011
This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints.
Apr 07, 2011
This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
Apr 07, 2011
21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.
Apr 07, 2011
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical