FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

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.

How do you create and blend the Risk Management File findings into your annual audit plan? How is it established, maintained, formally updated, and documented? Structured, defined and scheduled internal CGMP compliance audits are a specific requirement of US FDA 21 CFR 820 and ISO 13485 (devices), implied in 21 CFR 210, 211 (pharma)

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.

This program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices. This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.

Using a reliable process to meet current quality standards to determine the verifiable causes of problems. Root cause analysis is a systematic method to determine the causes of non-conformances. To meet current quality standards, medical device companies must use a reliable process to determine the verifiable causes of problems.

This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).

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.