$179.00
How to Certify Reprocessing Surgical Instruments According the Risk Class Ir in Europe?

 March 05 2020
 01 : 00 PM EST    
 90 Minutes
How to Certify Reprocessing Surgical Instruments According the Risk Class Ir in Europe?

The EU MDR 745/2017 is a complete game-changer to the old law of the MDD 93/42/EEC since 1993 with a couple of updates. The time is very short and the number of requirements and required changes is high. The training will show, how to conduct a gap analysis, an action plan and how to be on track until May 2020.  Learn, what to do into the quality management department and what to do in the regulatory a..

$179.00
US National Bioengineered Food Disclosure Act (GMO Labeling)

 March 06 2020
 01 : 00 PM EST    
 60 Minutes
US National Bioengineered Food Disclosure Act (GMO Labeling)

The new rule was highly anticipated by industry and will hopefully bring clarity to the long-standing GMO questions, cover financial and risk impact to businesses as well as helping consumers with educated food choices based on science, in short session encapsulates everything industry needs to know on launching the NBFDSA.Areas Covered     Background on US GMO (Genetically Modified Organism)..

$179.00
Essentials of Root Cause Analysis for CAPA

 March 09 2020
 01 : 00 PM EST    
 90 Minutes
Essentials of Root Cause Analysis for CAPA

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We’ll also cover the essentials of doing a failure investigation.Areas covered This 90-minu..

$179.00
Monitoring a Quality Laboratory to Prevent Non-Compliance

 March 09 2020
 01 : 00 PM EST    
 60 Minutes
Monitoring a Quality Laboratory to Prevent Non-Compliance

Everyone in a laboratory under compliance knows about 3-sigma out-of-control issues. Can the operation be monitored to avoid these? How? This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation to ensure that it is under control and to see when a problem is arising, but before it is outside of 3-sigma.Data quality and compli..

$179.00
Critical Planning for Exporting Devices to the EU

 March 17 2020
 01 : 00 PM EST    
 60 Minutes
Critical Planning for Exporting Devices to the EU

Exporting devices to the EU has new EU legal requirements. A device must have a valid CE mark. You must renew your CE mark certification every three years.  If you do not, your products cannot be marketed legally in the EU. If your product is not marketed in the U.S. Many U.S. devices are legally marketed in the EU, not the U.S., renewing your CE certification takes planning, a lot of planning. It is n..

$179.00
Human Error Reduction Techniques for Floor Supervisors

 March 18 2020
 01 : 00 PM EST    
 90 Minutes
Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the ..

$179.00
Developing a Strategic Approach to FDA Compliance for Computer Systems

 March 19 2020
 01 : 00 PM EST    
 90 Minutes
Developing a Strategic Approach to FDA Compliance for Computer Systems

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is ma..

$179.00
Managing the Transportation of Perishable Food Products

 March 19 2020
 01 : 00 PM EST    
 90 Minutes
Managing the Transportation of Perishable Food Products

This session is designed for any food industry supply chain players who rely on transportation delivery controls. Air Cargo, trucking, rail, freight forwarders, shippers and others in the food supply chain are key players in the transportation of temperature and humidity-controlled food goods and can benefit financially from offering sanitary and value-added sensor technology to their service packages. The ..

$179.00
PK/PD Studies in Drug Discovery and Development

 March 25 2020
 02 : 00 PM EST    
 60 Minutes
PK/PD Studies in Drug Discovery and Development

The webinar reviews the general concepts and basic elements of pharmacokinetics, pharmacodynamics, and their correlation. The use of PK/PD for dose selection during drug development will be described also with the presentation of a case study. The use of PK/PD will be described for the evaluation of both drug efficacy and safety. This will illustrate how the model-based drug development and, in particular, ..

$179.00
Developing an Effective CAPA Management and Root Cause Analysis System

 March 27 2020
 01 : 00 PM EST    
 60 Minutes
Developing an Effective CAPA Management and Root Cause Analysis System

In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which..

$179.00
Tobacco Industry Trends for Computer Systems Regulated by FDA

 March 27 2020
 01 : 00 PM EST    
 90 Minutes
Tobacco Industry Trends for Computer Systems Regulated by FDA

The Tobacco Control Act went into effect by the FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (..

$179.00
Hands-on help and Know-how Transfer

 March 30 2020
 12 : 00 PM EST    
 120 Minutes
Hands-on help and Know-how Transfer

The three main points of learning (I guess the goal for you is to learn). When writing down one’s own requirements, the understanding of what actually is going on is the first big learning step. Questioning and discussing possible ways forward is a major learning process. A lecture in the form of know-how transfer, prepared on the object of your specific situation, must be the highest quality of learning. T..

$179.00
Fundamental of Pharmacokinetics

 April 01 2020
 02 : 00 PM EST    
 60 Minutes
Fundamental of Pharmacokinetics

The webinar reviews the general concepts and basic elements of pharmacokinetics. The webinar will describe the processes that a drug undergoes after administration such as the absorption (when not administered intravenously), the distribution, including plasma protein binding, the metabolism (the biotransformation of the drug into its metabolites) and the excretion (via the bile in faces and via the kidney ..

$179.00
2020 Safe Food for Canadians Regulations

 April 03 2020
 01 : 00 PM EST    
 60 Minutes
2020 Safe Food for Canadians Regulations

Safe Food for Canadians Regulation (SFCR) kicked off January 2019 after several long gazette comment periods by the CFIA (Canadian Food Inspection Agency). This session delivers a broad overview of the standard and covers resources for compliance. Under this regulation, many food companies are now required to register for a license, with many aspects mimicking the new FDA FSMA requirements. The new portal, ..

$179.00
EU Medical Devices Regulation: The Practice

 April 06 2020
 01 : 00 PM EST    
 90 Minutes
EU Medical Devices Regulation: The Practice

The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class participants will be introduced to the new requirements in the Medical Device Regulation (MDR), incl..

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