All FDA Regulated Industry

$199.00
Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data and FDA Compliance

 June 14 2024
 03 : 00 PM EST    
 90 Minutes
Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data and FDA Compliance

Computer system validation has been regulated by FDA for more than 40 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or rep..

$199.00
Performing Virtual Internal Audits

 June 17 2024
 01 : 00 PM EST    
 60 Minutes
Performing Virtual Internal Audits

Conducting a virtual internal audit has become increasingly common in today's digital age, especially with the widespread adoption of remote work and technological advancements. While traditional audits involve physical presence and face-to-face interactions, virtual audits leverage digital tools and platforms to achieve similar objectives efficiently. Whether due to pandemic-related restrictions or the nee..

$199.00
Software development for Medical Devices under IEC 62304

 June 26 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
Design Controls for Medical Devices under a Quality Management System

 July 09 2024
 01 : 00 PM EST    
 60 Minutes
Design Controls for Medical Devices under a Quality Management System

Design controls are a discipline that everyone in the medical device industry have to come to grips with. It encompasses systems engineering, risk management, mechanical/electrical/software design, usability engineering, and testing (verification and validation). The documentation of these activities is critical to both develop a good product but also to ensure a smooth regulatory clearance.Areas CoveredBac..

$199.00
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

 July 16 2024
 01 : 00 PM EST    
 90 Minutes
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, they have the ability to change behavior, drive quality culture, and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize t..

$199.00
COTS, Cloud, and SaaS Systems and FDA Validation Compliance

 August 05 2024
 03 : 00 PM EST    
 90 Minutes
COTS, Cloud, and SaaS Systems and FDA Validation Compliance

“How can we perform an Installation Qualification (IQ) when the server is completely under the control of a vendor?”“How do we know the vendor will be able to manage security, backups, disaster recovery, and other aspects required to ensure data is collected and maintained with integrity?”“What about change control?”“How will we handle compliance with 21 CFR Part 11, FDA’s guidance for electronic records an..

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

 Recorded Webinar
 60 Minutes
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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..

$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..

$200.00
Data Integrity 21 CFR Part 11 Compliance

 Recorded Webinar
 90 Minutes
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Data Integrity 21 CFR Part 11 Compliance

The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to..

$200.00
Effective Batch Record Review

 Recorded Webinar
 60 Minutes
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Effective Batch Record Review

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 order to properly document all critical processing parameters that go along with the production an..

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