All FDA Regulated Industry

$200.00
Data Governance for Computer Systems Regulated by FDA

 Recorded Webinar
 90 Minutes
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Data Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st..

$200.00
De Novo Classification Process

 Recorded Webinar
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De Novo Classification Process

Unlike other countries in the world, the US uses a predicate-based system to classify its medical devices. For devices that have a predicate device in the marketplace, the classification process is quite straightforward. A predicate device is a legally marketed device, called a preamendments device, that was legally marketed prior to May 28, 1976, a device that has been reclassified from Class III to Class ..

$200.00
Developing an Effective CAPA Management and Root Cause Analysis System

 Recorded Webinar
 60 Minutes
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Developing an Effective CAPA Management and Root Cause Analysis System

In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which..

$200.00
Developing and Managing an Effective Change Control Program

 Recorded Webinar
 90 Minutes
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Developing and Managing an Effective Change Control Program

Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur. This Change Control training cour..

$200.00
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

 Recorded Webinar
 60 Minutes
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Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.Learning ObjectivesDiscuss what to do when problems o..

$200.00
Deviation Management – Investigations to Root Cause Analysis

 Recorded Webinar
 60 Minutes
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Deviation Management – Investigations to Root Cause Analysis

The fundamental failure identified by regulators evolves from companies not knowing how to conduct investigations, how to identify the root cause, and how to select actions to correct the problems such that they never recur. The key to performing effective investigations is the timely gathering of all the facts necessary to understand what happened, and more importantly, what is wrong before we can begin to..

$200.00
Device and Software Changes and The 510(k)

 Recorded Webinar
 90 Minutes
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Device and Software Changes and The 510(k)

This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results-driven 510(k) / change analysis activities, based on the U.S. FDA has its current two recent “Final Guidance for Industry and FDA Staff”: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device..

$200.00
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

 Recorded Webinar
 60 Minutes
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Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how Disaster Recovery and Business Continuity Planning should be carried out. This is necessary to protect against the onslaught of threats and attacks, both from natural disasters ..

$200.00
Domestic and Foreign Medical Device Regulatory/Reimbursement Strategies

 Recorded Webinar
 90 Minutes
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Domestic and Foreign Medical Device Regulatory/Reimbursement Strategies

In general, all commercial medical devices require regulatory approval, for obvious reasons. Of equal importance, is to have a reimbursement pathway in each country where the device sale is targeted. One must get a reimbursement assessment early--while still in the product design phase. One must understand how your device may or may not fit within current payment methodologies such as DRGs, resource-based r..

$200.00
Drug or Cosmetic? Promoting Health Benefits in Personal Care Products

 Recorded Webinar
 60 Minutes
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Drug or Cosmetic? Promoting Health Benefits in Personal Care Products

FDA has a history of avoiding discussion of popular issues and leaving the course of history to the imagination of the industry to push the boundaries of regulatory compliance. The unwillingness by FDA to address issues like “natural”, “probiotic”, “CBD” and other popular issues, creates an opportunity to add market potential, but it also creates hazards to avoid for FDA regulated products. Assuming that di..

$200.00
Drug Product Performance, In Vivo: Bioavailability and Bioequivalence

 Recorded Webinar
 90 Minutes
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Drug Product Performance, In Vivo: Bioavailability and Bioequivalence

Drug product performance, in vivo, is defined as the release of the drug substance from the drug product leading to the bioavailability of the drug. The evaluation of drug product performance relates bioavailability to the therapeutic response and adverse events. Bioavailability and bioequivalence studies are measurements of drug product performance and can be used to evaluate new drug formulations, changes..

$200.00
Effective and Practical use of FMEA for Risk-Based Approach to Computer Systems Validation

 Recorded Webinar
 90 Minutes
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Effective and Practical use of FMEA for Risk-Based Approach to Computer Systems Validation

Validation of computer systems is a regulatory requirement within the life sciences. "How much to validate" is one of the biggest challenges validation teams face. The struggle to balance time and available resources with compliance requirements often leads to insufficient testing and/or project overruns, which in turn can lead to significant regulatory and safety risks. One way to avoid these issues is to ..

$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
Essentials of Root Cause Analysis for CAPA

 Recorded Webinar
 90 Minutes
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Essentials of Root Cause Analysis for CAPA

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We’ll also cover the essentials of doing a failure investigation.Areas Covered This 90-minu..

$200.00
Establishing a Robust Supplier Management Program

 Recorded Webinar
 90 Minutes
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Establishing a Robust Supplier Management Program

Regulatory expectations are clear about manufactures’ responsibility regarding supplier quality oversight. All regulatory agencies agree that pharmaceutical and medical device manufacturers are responsible for ensuring their suppliers adhere to quality standards, maintain compliance with regulatory requirements and consistently meet established expectations. Therefore, it is essential pharmaceutical and med..

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