Pharmaceutical

Pharmaceutical companies discover, develop, produce, and markets drugs or pharmaceutical drugs for use as a medication to be administered or self-administrated to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal with genetic or brand medications and medical devices. In the Unites States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves the submission of an investigational new drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III is a very large study of efficiency in the intended patient population. Following the successful completion of phase III a new drug, we submitted it to FDA. The FDA reviews the data and if the product is seen as having a benefit-risk assessment, approval to market the product in the US is granted.

$179.00

 July 30 2021

 01 : 00 PM EST    

 60 Minutes

Avoiding 483s Throughout Your Organization – Strategies, Risk, and Mitigating Approaches

Certainly, the most simplistic solution to achieving compliance excellence and 483 avoidance is “to do the right things right!” But what does this really mean?I have distilled the “doing the right things right” solution into 7 separate individual keys or actions that will provide a solid foundation for the establishment of any 483 avoidance program. Why should you attend this Webinar? Because as..

$179.00

 August 10 2021

 01 : 00 PM EST    

 90 Minutes

Avoid 483 Observations and Warning Letters

U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820), plus “current”. They are then required to translate those regulations into procedures and work instructions. Many companies who are successfully doing that are still failing audits, facing major recall, an..

$179.00

 August 10 2021

 02 : 00 PM EST    

 60 Minutes

Gray Areas in Cosmetic Regulation. Marketing Claims That Avoid Regulatory Issues

FDA has a history of avoiding discussion of popular issues and leaving the course of history to the imagination of industry to push the boundaries of regulatory compliance. The unwillingness by FDA to address issues like “natural”, “probiotic”, “CBD” and other popular issues, creates an opportunity to add market potential, but it also creates hazards to avoid for FDA-regulated products. Dietary ..

$179.00

 August 10 2021

 01 : 00 PM EST    

 60 Minutes

Transitioning FCPA and Other Temporary Regulations Under the New Normal for the Food Industry

The COVID-19 crisis has brought extraordinary strains to business practices and compliant supply chains. Ensure your organization is protected before and during an investigation. Join us by registering today. The current pandemic has forced regulators and industry to rethink how to achieve Food Safety surveillance and compliance for the industry with Supply Chain, Transportation, and Worker Safe..

$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 18 2021

 01 : 00 PM EST    

 60 Minutes

Best Practices for Deviation Training

Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees, or recalls.Learning ObjectivesDiscuss what to do when problems ..

$179.00

 August 18 2021

 01 : 00 PM EST    

 60 Minutes

Medical Device Software per IEC 62304

This course 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 no..

$179.00

 August 20 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

 August 24 2021

 01 : 00 PM EST    

 60 Minutes

Sterilization of Pharmaceutical Products and Medical Devices

Pharmaceutical products and medical devices are required to be sterile to be used in patients. Sterilization of these crucial products can be done in several ways depending on the characteristics of the product being sterilized. There are four typical ways a product can be sterilized. These are sterilization by Ethylene Oxide, Gamma irradiation, Steam and Pressure, and filtration. Knowing the characteristic..

$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

 August 30 2021

 01 : 00 PM EST    

 60 Minutes

Usability Engineering Under IEC 62366

ANSI/AAMI/IEC 62366 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance to it provides a presumption of conformity to the requirements within those jurisdictions. Compliance with the standard helps both ensure a smooth path to market clearance and drives a safer product.IEC 62366 is the recognized standard for Usability Engineering for m..

$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, ..

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