$200.00
Managing an FDA Foreign Inspection

 Recorded Webinar
 60 Minutes
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Managing an FDA Foreign Inspection

Agreeing to an FDA foreign inspection requires careful preparation on a firm’s part. If you do not manage your inspection wisely, you will set yourself up for disaster. We will cover fundamental issues, such as pre-inspection tasks, preparing your documents and having an interpreter before, during and after the inspection. We will also address how you should respond to inspectional problems noted by the FDA..

$200.00
Stability Studies and Estimating Shelf Life with Regression Models

 Recorded Webinar
 75 Minutes
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Stability Studies and Estimating Shelf Life with Regression Models

Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of their products so that customers know when the product can be expected to perform as intended. Many approaches are available to quantify the "shelf life" and the method(s) chosen often depend on the testing time available.This webinar discusses the steps to set-up a stability study and analyzes the results to ..

$179.00
Proper Management of Regulatory Agency Inspections

 February 21 2020
 01 : 00 PM EST    
 60 Minutes
Proper Management of Regulatory Agency Inspections

The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Many times, the arrival of a Regulatory Investigator is a daunting experience for some. In this webinar, ..

$200.00
Equipment Validation, Tracking, Calibration and Preventive Maintenance

 Recorded Webinar
 60 Minutes
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Equipment Validation, Tracking, Calibration and Preventive Maintenance

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces a product ..

$200.00
Laboratory Investigation of Out-of-Specification (OOS) Results

 Recorded Webinar
 60 Minutes
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Laboratory Investigation of Out-of-Specification (OOS) Results

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely. Specifically, there is a concern as to whether the laboratory and the company apply good science to the investigation of laboratory test results that ar..

$200.00
Verification, Validation, Master Planning for U.S FDA and ISO 13485 Compliance

 Recorded Webinar
 90 Minutes
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Verification, Validation, Master Planning for U.S FDA and ISO 13485 Compliance

How can companies address the U.S. FDA’s tougher stance and product, process and QMS V&V? One major failing is the lack of sufficient or targeted risk-based V&V Master Planning. Why do companies need a Validation Master Plan? What is it? How is it structured? Supporting systems/documents? How should each individual V&V plan be structured? Clarification of validation terms. Device, product, proce..

$200.00
Understanding Aseptic Technique and Cleanroom Behavior

 Recorded Webinar
 60 Minutes
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Understanding Aseptic Technique and Cleanroom Behavior

Aseptic technique, in sterile compounding, contributes to prevent microbiological contamination. Aseptic technique is being used to provide safety, efficacy, and sterility to the products that are sterile in nature, especially when it comes to various patient injections. This course by expert speaker Danielle DeLucy will benefit those Aseptic operators, Aseptic sample handlers, personnel who work in a Biolo..

$200.00
FDA Compliance and Clinical Trial Computer System Validation

 Recorded Webinar
 90 Minutes
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FDA Compliance and Clinical Trial Computer System Validation

The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of human clinical trials required for drug approval. FDA oversight is based on a Predicate Rule, known as “Good Clinical Practices,” or simply, “GCPs.” Computer systems subject to GCP requirements must be thoroughly and appropriately validated in accordance with FDA’s guidance on computer system valida..

$200.00
Step by Step Process for Successful Sterility Failure Investigations

 Recorded Webinar
 90 Minutes
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Step by Step Process for Successful Sterility Failure Investigations

There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, the environment and the like. As such, there is no one size fits all investigation.  Microbiological testing covers a wide range of products, processes, and..

$200.00
Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach

 Recorded Webinar
 90 Minutes
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Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach

This webinar will highlight difficulties in obtaining relevant and useful dissolution results based on current practices. This will be followed by the description of principles of drug dissolution testing leading to a simple and common set of experimental conditions reflecting a bio-relevant method. The discussion will be presented describing that the suggested bio-relevant method would become a QC method a..

$200.00
Writing Effective Standard Operating Procedures and Work Instructions

 Recorded Webinar
 60 Minutes
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Writing Effective Standard Operating Procedures and Work Instructions

Standard Operating Procedures and work instructions – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other tha..

$200.00
Pragmatic Approach to Pharmacovigilance/Drug Safety System Update Against the Latest New Requirements

 Recorded Webinar
 60 Minutes
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Pragmatic Approach to Pharmacovigilance/Drug Safety System Update Against the Latest New Requirements

In the last year/recent months, there have been a lot of changes in the pharmacovigilance requirements especially impacting the reporting to EudraVigilance, the Signal Detection Management (e.g. inclusion of EudraVigilance Data Analysis System as part of the Signal Detection Management, etc.) and the Risk Management activities. The course is aimed at providing some practical examples of the application of t..

$200.00
Modeling and Optimizing Process/Product Behavior using Design of Experiments

 Recorded Webinar
 75 Minutes
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Modeling and Optimizing Process/Product Behavior using Design of Experiments

Experimentation is frequently performed using trial and error approaches which are extremely inefficient and rarely lead to optimal solutions.  Furthermore, when it’s desired to understand the effect of multiple variables on an outcome (response), “one-factor-at-a-time” trials are often performed. Not only is this approach inefficient, it inhibits the ability to understand and model how multiple variab..

$200.00
Batch Record Review and Product Release

 Recorded Webinar
 60 Minutes
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Batch Record Review and Product Release

This webinar will analyze each of these necessary elements of the batch record review process.Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in ord..

$200.00
FDA Regulations Associated with the Detection, Correction and Prevention of Human Errors in GMP Manufacturing and Laboratory Processes

 Recorded Webinar
 90 Minutes
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FDA Regulations Associated with the Detection, Correction and Prevention of Human Errors in GMP Manufacturing and Laboratory Processes

We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information, you will be able to develop meaningful CAPAs that have a chance to remedy these proble..

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