FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This session describes how to use the GAMP® standard to determine what has to be validated and explains how to create documentation that will meet regulatory requirements worldwide.

In this Good Laboratory Practices training on FDA warning letter learn how to avoid making the same mistakes in your study and to avoid having your company's name publically cited for inspection findings.

In this seminar, you will learn how to document unexpected situations accurately and completely. Are your investigations done haphazardly or in an inconsistent manner? Are your reports hard to understand? Is the discrepancy resolution process slowing your product release efforts unnecessarily?

This presentation will discuss the differences between qualifications and validations as they apply to shipping and packaging. The objective of a shipping qualification program is to verify that product can be shipped throughout the supply chain within required temperature ranges and without damage. To accomplish this companies must conduct operational and performance qualifications for their shipping configurations. The operational qualifications consisted of temperature mapping of test loads that are challenged with “worst case” temperature profiles under controlled laboratory conditions. The performance qualifications were performed concurrent with actual product shipments.

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. This session will be the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Participants will learn how to write CA reports that will be used as written & how a well maintained CAPA system will save the company time and money. This course summarizes the cGMP requirements for Corrective Action Preventive Action (CAPA) and prepares participants to complete CAPA investigations on their own.

An assessment of your people to determine who should be talking with the FDA and most importantly, who should not must be performed. This webinar will provide the process map for the compliance and quality staff to build their strategy and plans for preparing for and executing their preparation work for a PAI in the Pharmaceutical and Biotechnology world.

This regulatory training will provide benefits to companies’ required to have a process for collecting, assessing and documenting deviation and complaints and ensuring that corrective and preventive actions are compliant with GXP requirements.

This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of an inspector at your front door. This Webinar will provide valuable assistance to all regulated companies that face unscheduled inspections by regulatory agencies.

To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly. This Webinar will provide invaluable assistance to investigators and staff with regulatory/ legal responsibilities. It also delves into the complex ethical considerations in pharmaceutical product (drug or device) research involving human subjects.

This presentation covers all of the steps one should take when beginning the IDE process for a PMA.

This webinar will provide valuable assistance to all regulated companies that need to validate their systems In this session we will introduce basic control charting and statistical methods to determine if a process is capable of consistently producing product within specifications and how to make it capable if it is not

This presentation will cover laboratory-related warning letters that contain 483s related to regulatory issues that affect pharmaceutical companies. While recent warning letters will receive the heaviest scrutiny, we will also cover old warning letters that serve to illustrate important points.

This presentation will review the documentation requirements, the electronic navigation aids required for all the components of the electronic datasets package for a clinical study. This webinar will provide valuable assistance to all pharmaceutical and biotechnology that are conducting clinical studies with the intent of filing Investigational New Drug (IND) and New Drug Applications (NDA) or Biological License Applications (BLA) submissions.

This presentation explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.

This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.

The presentation will use examples taken from warning letters to illustrate some of these problems, and discuss possible solutions. As an example, we will discuss the process for accepting raw material.

This program will cover the remaining regulations excluding the QSR which was covered in Part 1. This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.

While simple to describe many companies fall into the trap of territoriality, and confusion of roles and responsibilities. This webinar will walk through the elements of a process validation program for biological products with an emphasis on the involvement of all functions especially process development.

ComplianceOnline brings you a pack of 2 courses covering two of the major compliance areas faced by Clinical Laboratories.