Clinical Trial and Clinical Research

$199.00
Medical Device Cybersecurity and FDA Compliance

 October 16 2023
 01 : 00 PM EST    
 90 Minutes
Medical Device Cybersecurity and FDA Compliance

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection, software running on a medical device could cause severe injury or death to a patient.There are many forms of cybersecurity a..

$199.00
How to Ace Your Investigational New Drug Application: Prevent Clinical Holds

 October 19 2023
 01 : 00 PM EST    
 60 Minutes
How to Ace Your Investigational New Drug Application: Prevent Clinical Holds

The requirements for an IND submission can be complicated and can be hard to understand. Commercial IND applications must be submitted through the FDA’s Electronic Submissions Gateway, while Research IND applications can be submitted via CDER NextGen Portal. Casting aside the technical jargon and interpreting the regulations in 21 CFR 312, what does the road ahead of you look like? It is worth stating upfro..

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

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

 Recorded Webinar
 90 Minutes
 Refer a Friend
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
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities

 Recorded Webinar
 90 Minutes
 Refer a Friend
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities

This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in order to develop the appropriate strategy, policies and procedures to ensure compliance.Areas CoveredPros and cons of using social media venuesCompliant use of Social Media i..

$200.00
Implementing a Change Control Quality System Successfully

 Recorded Webinar
 60 Minutes
 Refer a Friend
Implementing a Change Control Quality System Successfully

This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..

$200.00
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

 Recorded Webinar
 90 Minutes
 Refer a Friend
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..

$200.00
21 CFR Part11 Compliance

 Recorded Webinar
 60 Minutes
 Refer a Friend
21 CFR Part11 Compliance

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants t..

$200.00
5S for Operators

 Recorded Webinar
 90 Minutes
 Refer a Friend
5S for Operators

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler..

$200.00
Advertising and Promotional Material Compliance and Review Process

 Recorded Webinar
 60 Minutes
 Refer a Friend
Advertising and Promotional Material Compliance and Review Process

The information obtained will enable the effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, strategies for mitigating risks, and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critica..

$200.00
An OSHA Inspection in the Laboratory

 Recorded Webinar
 60 Minutes
 Refer a Friend
An OSHA Inspection in the Laboratory

Do you know why OSHA would come to your lab? Do you know how to respond to an OSHA complaint or allegation? Join Dan the Lab safety Man as he discusses the steps to prepare your lab for an OSHA visit and how to properly respond when it actually happens.Areas CoveredReview the steps in OSHA’s inspection processDiscuss areas in the laboratory where potential OSHA violations are likelyCalculate possible fines ..

$200.00
Auditing Basics and Fundamentals for Medical Devices and Drugs

 Recorded Webinar
 100 Minutes
 Refer a Friend
Auditing Basics and Fundamentals for Medical Devices and Drugs

Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are also a fundamental tool of risk management. The auditor assures alignment with prescribed practices and is at the front line in evaluating control systems, testing, measurement and more. Auditors asses the acc..

$200.00
Auditing Quality Suppliers and Vendors

 Recorded Webinar
 90 Minutes
 Refer a Friend
Auditing Quality Suppliers and Vendors

The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.Learning Obj..

$200.00
Automating Assays for Clinical Diagnostics

 Recorded Webinar
 60 Minutes
 Refer a Friend
Automating Assays for Clinical Diagnostics

Laboratories need to transition technologies all of the time. From new ways to perform assays to outdated technology, to new equipment pushes to the various needs of end-users, assays need to switch between technologies on a regular basis. One needs to be able to easily and robustly transition assays from one technology to another. With this seminar, you will be able to fully understand how your essay is cu..

$200.00
Batch Record Review and Product Release

 Recorded Webinar
 60 Minutes
 Refer a Friend
Batch Record Review and Product Release

This webinar will analyze each of these necessary elements of the batch record review process.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 ord..

Showing 1 to 15 of 127 (9 Pages)