Albert A. Ghignone

Drug Approval: The FDA IND-NDA System

This webinar presents an overview of the entire FDA Drug Approval Process. The webinar addresses FDA requirements from discovery to USA marketplace. The webinar begins by developing a molecule, testing it, going through the IND process, human clinical testing and then the NDA process.

David Nettleton

Efficient Computer System Validation - 10 Easy Steps

This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project.

John E Lincoln

Product Hazard Analysis and Risk Management Under ISO 14971 and FDA, ICH Q9

This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a "living document".

David R. Dills

Webinar on Medical Device Tracking

The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so.

Heath Rushing

Using Design of Experiments (DOE)for Product-Process Development

Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product.

John N. Zorich

Confidence-Reliability Calculations and Statistically Valid Sample Sizes

Next, detailed descriptions are given for how to calculate confidence/reliability for data that is either pass/fail (i.e., "attribute" data), normally-distributed measurement data, non-normally distributed measurement data that can be transformed into normality, or non-normally distributed measurement data that cannot be transformed into normality.

Anna Longwell

Customer Interactions: Law, Policies, Ethics

The proliferation of legal requirements (law and regulation) governing the financial relationships between medical product companies and the doctors who order their products has led to what can only be described as a tangled mess. Many device companies have had to add personnel, or employ expensive consultants in order to have a hope of complying.

Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Lawrence F Muscarella  PhD

Solutions for Improving Infection Prevention in the Endoscopy Suite

This lecture focuses on the contribution of quality to patient safety and the practice of cost-effective medicine. Failure to properly clean and disinfect GI endoscopes and their accessories has been directly linked to disease transmission, with associated patient morbidity and mortality, increasing a GI endoscopy suite's legal exposure.

Albert A. Ghignone

The FDA Drug Development Process

This webinar provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations.

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