Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

This equipment cleaning validation webinar will explain cleaning validation program steps, cleaning agents selection, documentation, cleaning method set up and how to reproduce cleaning validation program and various simple but powerful tools for achieving an in-depth Cleaning Validation Program, and continuous monitoring that meets FDA expectations.

This GMP training will elucidate the key elements of world class QA and compliance practices specifically for animal health manufacturing companies. These practices support a robust quality system, ensure the firm’s quality standards remain current, and inform the GMP auditing and training processes.

This Medical device complaints handling webinar will discuss the best practices of complaint handling and how to include it in your CAPA program and how to apply risk management to the complaint handling system.

This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.

This project and alliance management webinar will present tools valuable for planning a project, identifying required outsourced activities, selecting a CDMO, monitoring/controlling an outsourced project, and communicating project performance to leadership.

This webinar will provide you with an Update on FDA’s judicious use strategy using antimicrobial drugs in Animal Feeds.

This pharmaceutical water systems webinar training will discuss what you should do when your monitoring data tells you that you may have a significant biofilm problem. It covers how to verify that the data and your interpretation of the data are correct, as well as the location of the problem which gives you clues as to what caused the problem and its impact on manufacturing and product.

This GMP webinar training will cover the design and implementation of a GMP surveillance program to ensure awareness of and compliance with ever-changing US and international GMP manufacturing regulations, guidance, inspection findings, trends, and related information, and how the process can be used to create GMP training and made even more valuable across the organization in the context of a quality knowledge management platform.

This is an advance level webinar that explains how to conduct identity testing of dietary components and what resources are required. It will benefit those who order, purchase, receive, inspect and analyze dietary components. It will also benefit those who have managerial and decision-making responsibilities.

This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.

This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations.

This webinar on Nutrition and Health claims (NHCR) will provide guidance to any food business operator intending to present food products as having nutritional or health benefits should be aware of the legal possibilities and limitations that the EU system offers.

This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data.

Microorganisms can be found in any aspect of pharmaceutical and, especially, biopharmaceutical manufacturing. Understanding where to look for microorganism and how these are introduced into your process will provide success when being reviewed by an auditor. It is not enough to identify microorganism in your process, but to understand, how, where, when, and why the microbes are in your process. These are questions regulatory auditors will ask when your facility is being inspected.

This VFD Final rule webinar is to give you better understanding what changes apply to you either as veterinarians, food animal producers or distributors.

This webinar will examine the rational use of biopharmaceutical principles to design a drug product that will optimize drug delivery to achieve the therapeutic objectives of the drug.

Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

This webinar will discuss the requirements for handling deviation based on GMPs, ICH guidance documents and other relevant guidance. It will also explain ICH Q8, Q9, and Q10 guidance documents and will provide best practices to ensure compliance with these documents in regards to handling deviations and nonconforming products.