Audits & Inspections Training - Live Webinars, Recordings & CDs

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

This webinar will discuss in detail key auditing elements of an Active Pharmaceutical Ingredient (API) facility/operation. It will cover selection, designation and documentation of starting materials; qualification of analytical methods; control requirements for multi-product/multi-processing API production facility; QA review and release of API and much more.

This training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

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 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 Pharmaceutical compliance training will outline actions to take to ensure the microbiological wellness of your facility and will introduce the concept of "Thinking like a Bug".

This Pharmaceutical compliance training will demonstrate how to implement an effective audit program for both manufacturing and the laboratory and the ability to maintain GMP/GLP/GCP compliance with all suppliers and/or vendors.

The presentation covers the requirements of the Code of Federal Regulations for drugs, biologics, and medical devices, as well as key FDA Guidance Documents including the International Conference on Harmonization (ICH) E6. This program is essential for management of clinical trial sponsors and vendors.

This (JPAL) Japanese Pharmaceutical Affairs Law training will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese.