All FDA Regulated Industry

$199.00
Corrective and Preventive Action (CAPA) and Root Cause Analysis

 March 13 2024
 01 : 00 PM EST    
 90 Minutes
Corrective and Preventive Action (CAPA) and Root Cause Analysis

Recognize that CAPA is arguably the most important process in the quality management system because so much else depends on it. CAPA is used to handle not only poor quality (the traditional application) but also audit findings, customer complaints, and outputs of the management review. It can even be deployed against the other six Toyota production system wastes by treating them as "nonconformances" or, mor..

$199.00
FDA Regulation of Artificial Intelligence and Machine Learning

 March 19 2024
 01 : 00 PM EST    
 60 Minutes
FDA Regulation of Artificial Intelligence and Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following d..

$199.00
Complying with 21 CFR 11 for Electronic Records/Electronic Signatures

 March 20 2024
 01 : 00 PM EST    
 60 Minutes
Complying with 21 CFR 11 for Electronic Records/Electronic Signatures

21 CFR Part 11 was promulgated in 1979 to address a gaping hole in the regulations regarding the use of electronic records and electronic signatures.  The rule was, by FDA’s admission later, confusing and challenging.  Learning ObjectivesOverview of 21 CFR Part 11Explain the concepts and rationale behind the rulesDiscuss the practical application of the rule Consider challenges with the ruleWho Sh..

$199.00
New FDA Draft Guidance Part 11 Compliance

 March 20 2024
 01 : 00 PM EST    
 90 Minutes
New FDA Draft Guidance Part 11 Compliance

This webinar describesAs part of the Case for Quality program US FDA noted how an excessive focus by the industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices. There has also been a lower-than-anticipated investment in automation and digital technologies, which could greatly improve..

$199.00
Good Documentation Guideline(Chapter <1029> USP)

 March 26 2024
 01 : 00 PM EST    
 60 Minutes
Good Documentation Guideline(Chapter <1029> USP)

Good Documentation Practices (GDP) are a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories, and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.This training session will cover the US Pharmacopeia Genera..

$199.00
FDA 483 or Warning Letter - Now What?

 April 01 2024
 11 : 00 AM EST    
 90 Minutes
FDA 483 or Warning Letter - Now What?

Regulatory compliance is a critical aspect of any industry governed by the U.S. Food and Drug Administration (FDA). Companies operating within these regulated industries strive to meet the FDA's stringent requirements to ensure product safety, efficacy, and consumer protection. However, even with robust compliance measures in place, there is always a possibility of FDA inspections uncovering deviations from..

$199.00
Understanding and Implementing a Technology Transfer Process

 April 04 2024
 01 : 00 PM EST    
 60 Minutes
Understanding and Implementing a Technology Transfer Process

Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However, the execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends on the careful development, m..

$199.00
How to Conduct a Human Factors / Usability Validation

 April 16 2024
 01 : 00 PM EST    
 60 Minutes
How to Conduct a Human Factors / Usability Validation

Following the implementation of the results of a Human Factors/Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain why the FDA required a number of validation participants from each "distinct user population". We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test..

$199.00
FDA 483s, Warning Letters and Enforcement Trends

 April 23 2024
 01 : 00 PM EST    
 90 Minutes
FDA 483s, Warning Letters and Enforcement Trends

Publicly available warning letters and inspection observation data provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities within your quality system. The fiscal year 2019 saw the most warning letters issued by the FDA to makers of finished pharmaceutical products in recent history During the last 12 months, a total of 81 warning letter..

$199.00
Most Common FDA Observations and How to Prevent Them

 May 01 2024
 01 : 00 PM EST    
 90 Minutes
Most Common FDA Observations and How to Prevent Them

The training program "Most Common FDA Observations and How to Prevent Them" offers a comprehensive and practical approach to address the challenges organizations face in maintaining compliance with U.S. Food and Drug Administration (FDA) regulations. Designed for professionals in regulated industries such as pharmaceuticals, medical devices, biotechnology, food and beverages, cosmetics, and dietary suppleme..

$199.00
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles of Lean Documents and Lean Configuration

 May 14 2024
 01 : 00 PM EST    
 60 Minutes
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles of Lean Documents and Lean Configuration

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents present a fresh departure from these practices while b..

$199.00
Software development for Medical Devices under IEC 62304

 May 23 2024
 01 : 00 PM EST    
 60 Minutes
Software development for Medical Devices under IEC 62304

IEC 62304 is both a recognized consensus standard by the FDA and a harmonized standard in the EU; therefore, being compliant with the standard is the most expedient path forward for medical device products that are or contain software. IEC 62304 is also called out as a standard under the IEC 60601-1 umbrella and thus compliance to 62304 is also the best path through product safety testing (if applicable to ..

$199.00
Medical Device Industry Trends- 2023 and Beyond

 June 03 2024
 01 : 00 PM EST    
 90 Minutes
Medical Device Industry Trends- 2023 and Beyond

The medical device industry is in a state of constant evolution, driven by advancements in technology, shifting market dynamics, and the ever-changing needs of patients and healthcare providers. Staying ahead of the curve and understanding the latest trends is crucial for professionals in this dynamic field. The training program on "Medical Device Industry Trends" offers a comprehensive and insightful explo..

$200.00
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

 Recorded Webinar
 90 Minutes
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21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.Areas CoveredCompu..

$200.00
5 Key Components of Good Manufacturing Practices to obtain cGMP certification

 Recorded Webinar
 60 Minutes
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5 Key Components of Good Manufacturing Practices to obtain cGMP certification

Pharmaceutical and other FDA-regulated industries are tasked with safely manufacturing products for people (or animals) around the world. The FDA has set specific requirements, known as cGMPs) for facilities to meet the standards for a product to be deemed safe, pure, and effective. Good Manufacturing Practices are critical to any organization that produces products for the public. This training will discus..

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