FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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

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.

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.

This presentation will discuss the quality-related activities that are expected for different stages of the product development process. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for DMFs and NDAs (or BLAs) will be discussed.

Learn the appropriate and expected regulatory strategies and guidelines for your IDE. This webinar will provide valuable assistance and guidance to medical device firms that are currently preparing or will prepare for IDE submissions.

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 presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes. This webinar will be directed at workers with some experience who must now deal with the manufacturing of various biological products.

This webinar will describe the origins and rationale for the QbD program. It will describe the successes in the generic and drug areas and the opportunities in the biologics areas. The fruits of the program can bring a higher success rate in the commercial operations with its impact on cost of goods, reduced reporting requirements or at least a reduction in the level of reporting for supplements and less complex or stressful inspections.

Understand why the VMP is a project management tool and why it’s a living, breathing document. This webinar will provide valuable assistance and guidance to all life sciences manufacturers that are preparing to use or are currently using validation master plans to bullet-proof their validation programs.