Health & Medical - Documentation & Proceedings

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures.

This Medical Device Directive training will discuss the recently implemented and currently planned changes to the Medical Device Directives across the EU. It includes specific insight from direct involvement.

This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.

This OSHA injury and illness recordkeeping training will teach you how OSHA analyzes recordkeeping scenarios by focusing on those concepts and rules that are most commonly misunderstood by recordkeepers and their bosses

This clinical trial audit webinar will help with preparing the site and the study team with how to successfully prepare for an audit, how to identify risk of noncompliance, what to do before, during and after an audit.

This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.

This webinar on Trial Master File (TMF) for clinical research sites will show how you can create an FDA compliant TMF to ensure that it will pass inspection by FDA investigators and QA Auditors.

This webinar will help you understand the application and requirements of OSHA Process Safety Management and the topics that have been interpreted and reviewed in the compliance guidelines.

Since the prosecution of off-label uses has intensified, companies need to revisit everything they do in the off-label arena. While off-label “sales” have never been illegal, because physicians can and do lawfully prescribe products for off-label uses, off-label “promotion” is illegal.

Understand what is the CER and how to prepare for and defend it and properly constructing a "bullet-proof Technical File and manage your documentation.

In this Clinical Statistics webinar/training all topics will be taught from a practical, non-theoretical perspective for non-statisticians & value and meaning of descriptive statistics including the use of normal vs. non-normal statistics.

Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Understand the structure of validation plan, documentation of ongoing performance, structure of validation report.

This webinar on Objectionable Micro-organisms will provide examples of objectionable microorganisms and will review specific actions to take when one is found. It will also review how to conduct an effective risk analysis to mitigate the risk they present.

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.