All FDA Regulated Industry

$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New FDA Draft Guidance Part 11 Compliance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New FDA Draft Guidance Part 11 Compliance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
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
Effectively Managing CMO / CDMO

 May 21 2024
 01 : 00 PM EST    
 90 Minutes
Effectively Managing CMO / CDMO

Regulatory expectations are clear about manufacturers’ 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 to regulatory requirements and consistently meet established expectations. Therefore, it is essential pharmaceutical and medi..

$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
Good Documentation Practice and Record Keeping Regulations (FDA and EMA)

 October 17 2024
 01 : 00 PM EST    
 60 Minutes
Good Documentation Practice and Record Keeping Regulations (FDA and EMA)

Good documentation Practices (GDP) are an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general r..

$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..

$200.00
Analytical Method Validation and Transfer

 Recorded Webinar
 90 Minutes
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Analytical Method Validation and Transfer

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of thi..

$200.00
Basic Validation Statistics for Non - Statisticians

 Recorded Webinar
 60 Minutes
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Basic Validation Statistics for Non - Statisticians

In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the c..

$200.00
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

 Recorded Webinar
 90 Minutes
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Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..

$200.00
Corrective and Preventive Action (CAPA) and Root Cause Analysis

 Recorded Webinar
 90 Minutes
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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..

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