Medical Devices

$179.00
Conducting a Successful Supplier Audit

 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 knowledge..

$300.00
Food Labeling In MX

 September 24 2021
 05 : 00 PM EST    
 180 Minutes
Food Labeling In MX

General Mexican labeling specifications for pre-packaged foods and non-alcoholic beverages have been submitted to different changes due to health policies in Mexico. In order to comply with the new guidelines, you’ll need to cover numerous rules, standards, and some other regulations.Receive the most up-to-date information first-hand from an industry expert that collaborated through the ICC in the most rece..

$179.00
Medical Device Software per IEC 62304

 September 28 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
Manufacturing Drugs and Cosmetics On Shared Equipment

 October 12 2021
 02 : 00 PM EST    
 60 Minutes
Manufacturing Drugs and Cosmetics On Shared Equipment

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 under the..

$179.00
Method Validation Under Good Laboratory Practices (GLP)

 October 20 2021
 01 : 00 PM EST    
 60 Minutes
Method Validation Under Good Laboratory Practices (GLP)

Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees the validity of results. If you work in pharmaceuticals, chemicals, and petrochemicals, and environmental analyses then you are mandated to be following GLP. One of the major tasks in GLP is the validation of an analytical method.The new pharmaceutica..

$179.00
How to Prepare a Standard Operating Procedure (SOP)

 October 21 2021
 01 : 00 PM EST    
 60 Minutes
How to Prepare a Standard Operating Procedure (SOP)

Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit. Technically, all FDA inspections include an SOP review and it is very important to ha..

$179.00
Proper Management of Regulatory Agency Inspections

 October 28 2021
 01 : 00 PM EST    
 60 Minutes
Proper Management of Regulatory Agency Inspections

The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Many times, the arrival of a Regulatory Investigator is a daunting experience for some. In this webinar, ..

$179.00
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

 November 12 2021
 01 : 00 PM EST    
 60 Minutes
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommendations to assure that in addition to being able to illustrate compliance, your firm’s CAPA system is useful and meaningful. CAPA is th..

$179.00
Manufacturing Non-sterile Products Intended For Use In Healthcare Settings

 November 16 2021
 02 : 00 PM EST    
 60 Minutes
Manufacturing Non-sterile Products Intended For Use In Healthcare Settings

Cosmetics and OTC products that are intended for use in healthcare settings are being used by individuals that are vulnerable to opportunistic pathogens. Products including lotions, creams, toothpaste, mouthwash and mouth moisturizers are commonly given to patients for their personal use while in the hospital. Other products like surgical preparations and shared hand creams for workers can become contaminat..

$179.00
Implementing a Change Control Quality System Successfully

 November 18 2021
 01 : 00 PM EST    
 60 Minutes
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 ObjectivesIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrat..

$179.00
GMPs for Cannabis Operations

 November 19 2021
 01 : 00 PM EST    
 60 Minutes
GMPs for Cannabis Operations

This webinar will provide a basic foundation for Good Manufacturing Practices essentially for any medical marijuana production operation. Medical marijuana growing and production is a regulated industry and is becoming more regulated every day. GMPs pertain to medical marijuana just as they do to pharmaceutical, medical device biologics, foods, etc. Unfortunately, there is no unified standard as to how they..

$179.00
Good Documentation Guideline (Chapter <1029> USP)

 November 18 2021
 01 : 00 PM EST    
 60 Minutes
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories, and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system. This training session will cover the US Pharmacopeia Genera..

$179.00
Proper Execution of Annual Product Reviews

 December 10 2021
 01 : 00 PM EST    
 60 Minutes
Proper Execution of Annual Product Reviews

Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize product defects and also the risks associated with the manufacturing of the pharmaceutical product.Areas Co..

$179.00
The FDA Inspection: Best Practices for Preparation, Management, and Follow-Up

 December 10 2021
 01 : 00 PM EST    
 60 Minutes
The FDA Inspection: Best Practices for Preparation, Management, and Follow-Up

This session will discuss how to prepare for the inspection, what to do during the inspection, and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.Areas CoveredTypes of InspectionsPrepa..

$149.00
FDA Best Audit Practices

 March 26 2021
 01 : 00 PM EST    
 60 Minutes
FDA Best Audit Practices

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors. A key component of this webinar is the discussion of the..

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