All FDA Regulated Industry

$199.00
New FDA Draft Guidance Part 11 Compliance

 April 26 2024
 11 : 00 AM 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New FDA Draft Guidance Part 11 Compliance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
Complying with 21 CFR 11 for Electronic Records/Electronic Signatures

 May 03 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
GAMP®5, 2nd Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

 May 15 2024
 03 : 00 PM EST    
 90 Minutes
GAMP®5, 2nd Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Gain an understanding of how newer technology should be handled when performing validation work. A different approach will be covered during the session.We will also discuss best industry practices to ensure all systems, including technology that has been around for decades, yet until recently, these were rarely used in the life science industry. (e.g., cloud, Software-as-a-Service (SaaS), Electronic Record..

$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
Writing and Enforcing SOPs: Best Practices for Regulated Industries

 June 12 2024
 01 : 00 PM EST    
 90 Minutes
Writing and Enforcing SOPs: Best Practices for Regulated Industries

Writing and enforcing effective standard operating procedures (SOPs) can be challenging. Poorly written SOPs are one of the most common causes of deficiencies and observations cited in 483s and warning letters from the FDA. Companies in regulated industries must know how to organize and deliver information for the intended audience and the intended purpose. Participants will learn how to organize and delive..

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

 June 14 2024
 03 : 00 PM EST    
 90 Minutes
Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & 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
How to Conduct a Human Factors / Usability Validation

 June 18 2024
 01 : 00 PM EST    
 60 Minutes
How to Conduct a Human Factors / Usability Validation

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 10..

$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..

$199.00
Trends in FDA Compliance and Enforcement for Regulated Systems

 October 16 2024
 03 : 00 PM EST    
 90 Minutes
Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the ..

$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..

$199.00
Best Practices in Preparation for an FDA Computer System Audit

 November 13 2024
 03 : 00 PM EST    
 90 Minutes
Best Practices in Preparation for an FDA Computer System Audit

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it ..

$199.00
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

 December 11 2024
 03 : 00 PM EST    
 90 Minutes
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

FDA has substantial authority to oversee regulated companies and their operations.  The primary purpose for FDA is to assure safe and effective products that will protect public health.  Violations can have seriously adverse effects on products, and ultimately, on patients and consumers.The root of every company’s effort to defend their practices and products is through data and documentation, mea..

$199.00
Computer System Validation (CSV) Boot Camp (3-day intensive training)

 January 21 2025
 11 : 30 AM EST    
 180 Minutes
Computer System Validation (CSV) Boot Camp (3-day intensive training)

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.  We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also dis..

$199.00
Data Integrity and Privacy: 21 CFR Part 11, Annex 11, and General Data Protection Regulation (GDPR)

 February 06 2025
 03 : 00 PM EST    
 90 Minutes
Data Integrity and Privacy: 21 CFR Part 11, Annex 11, and General Data Protection Regulation (GDPR)

In this webinar, we will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.We will discuss traditional CSV vs. CSA, the draft guidance issued in September 2022 by FDA, indicating the differen..

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