Clinical Trial and Clinical Research

Clinical trials are experiments or observations done in clinical research? Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions or behavioral interventions, including new treatments such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received the health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean the therapy is safe or effective, only that the the trial may be conducted.

$179.00

 August 13 2021

 01 : 00 PM EST    

 60 Minutes

De Novo Classification Process

Unlike other countries in the world, the US uses a predicate-based system to classify its medical devices. For devices that have a predicate device in the marketplace, the classification process is quite straightforward. A predicate device is a legally marketed device, called a preamendments device, that was legally marketed prior to May 28, 1976, a device that has been reclassified from Class III..

$179.00

 August 25 2021

 01 : 00 PM EST    

 60 Minutes

Method Validation of HPLC/UPLC Methods

Instrumental liquid chromatography, either as HPLC or UPLC, are a common technique in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental liquid chromatography is an analysis that is widely used to determine purity, im..

$179.00

 September 15 2021

 01 : 00 PM EST    

 60 Minutes

How FDA Trains its Investigators to Review CAPA and What Should You do to Prepare

During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by the FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by wh..

$179.00

 September 1 2021

 01 : 00 PM EST    

 60 Minutes

The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handled by adjustments rather than the strict s..

$179.00

 September 10 2021

 01 : 00 PM EST    

 60 Minutes

Classifying Medical Devices in the US and the EU

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The determination pr..

$179.00

 September 14 2021

 02 : 00 PM EST    

 60 Minutes

Cosmetic cGMPs, Are You Complying?

It is common for personal care product manufacturers to dismiss the importance of applying strong GMP’s to cosmetic product manufacturing. Even the best-run firms are prone to FDA oversite due to shortcomings in their operations. On the scale of FDA regulatory responsibilities, cosmetics are as low as you can go. So why worry? It is easy to forget that all of the regulatory powers given to the FDA..

$179.00

 September 14 2021

 01 : 00 PM EST    

 60 Minutes

Guidance for Lubricant Use in Food Application

Over application or incorrect usage of lubricants can lead to insanitary conditions or contamination. Often condensate plays a big part in refrigerated foods and mixed with improper use of lubricants can spell potential problems in the environment. Proper application for lubricant use, examples of both good and poor practices will be covered, as well as watch-outs for industry, tracking recommendations, lub..

$179.00

 September 14 2021

 01 : 00 PM EST    

 60 Minutes

Objectionable Microorganisms in Pharmaceutical Manufacturing

Objectionable microorganisms are considered if discovered, harmful to the patient. By identifying and controlling these microorganisms, then putting the appropriate controls place early in the pharmaceutical manufacturing or medical device manufacturing process problems in the patient can be prevented. This webinar will review the regulations pertaining to objectionable microorganisms, agency expectations, ..

$179.00

 September 14 2021

 01 : 00 PM EST    

 60 Minutes

Risk Based Computer System Validation

FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than the validation of device software (embedded software). Validation is much more than testing. It is testing plus design control and configuration management.How to plan and conduct a risk-based validation will be explained. The overall risk for a com..

$179.00

 September 16 2021

 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, ..

$179.00

 September 17 2021

 01 : 00 PM EST    

 60 Minutes

Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage

This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need to understand the methodologies used by FDA during inspections. During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used ..

$300.00

 September 20 2021

 01 : 00 PM EST    

 180 Minutes

IEC 62304 and Demystifying Software Validation using the Principles of Lean Documents and Lean Configuration

This webinar is essential for Medical Device companies interested in submitting software-enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company’s face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and n..

$179.00

 September 21 2021

 03 : 00 PM EST    

 60 Minutes

Assessment of Drug-drug Interactions in Drug Development

During drug development, the in vitro drug metabolism and drug transporter interaction studies should allow understanding the need for and the timing of clinical drug interaction studies. These in vitro studies should be completed before the product is administered to patients who are likely to take concomitant medications that could interact with the investigational drug. These studies should assess the ef..

$179.00

 September 22 2021

 01 : 00 PM EST    

 60 Minutes

Validation of GC/ GC-MS Methodologies

Instrumental gas chromatography, either as GC or GC-MS, is a common technique in laboratories that do regulatory compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental gas chromatography is an analysis that is widely used to determine purity, impurities..

$179.00

 September 23 2021

 01 : 00 PM EST    

 60 Minutes

Conducting a Successful Supplier Audit

When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit its operation. This webinar is designed to provide the participants a working knowl..

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