Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Webinar defines the role of the CRO to ensure that each party is meeting its responsibilities. CRO audits ensure that the study data and results are credible and accurate, and that the rights and well-being of study subjects have been protected.

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.

This webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs.

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.

This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval.

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 webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.

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.

Emphasis is placed on conducting effective process auditing through an internal audit program within a company’s quality management system. This webinar is intended to review the requirements for determining if a company has its processes under control, with reviews of the requirements and description of the methods to determine which processes are expected to be audited.

This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries. This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

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.

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)

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device as well as track post market risks. Participants in this webinar will learn about techniques that will be useful in analysis of post market human factors design problems and in preventing these problems through pro-active use of post-market surveillance techniques and customer support data.