Laboratory

$200.00
New FDA and EMA Labeling Requirements for Regulated Industries

 Recorded Webinar
 90 Minutes
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New FDA and EMA Labeling Requirements for Regulated Industries

This webinar will help you understand in detail the new requirements for labeling from FDA and EMA, including a set of rules for electronic submission of labeling content, and strategies and actions for meeting the new challenges posed.Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as ..

$200.00
PK/PD Studies in Drug Discovery and Development

 Recorded Webinar
 60 Minutes
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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, ..

$200.00
Qualification and Control of Contract Manufacturers (CMO) Based on Practical Experience

 Recorded Webinar
 60 Minutes
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Qualification and Control of Contract Manufacturers (CMO) Based on Practical Experience

CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements and the author’s personal experience in qualifying over 40 CMO’s in the medical device industry. The control of changes is one such topic that is complex. Lessons from practical experience show methods that will prevent a development program from becoming uncompli..

$200.00
Qualification of Suppliers and Contract Manufacturing Organizations

 Recorded Webinar
 60 Minutes
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Qualification of Suppliers and Contract Manufacturing Organizations

Suppliers and CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements. Phases of supplier and CMO selection from initial telephone inquiry to the quality survey to qualification audit will be explained. The qualification audit will be described with key points to evaluate explained. How to deal with uncooperative suppl..

$200.00
Quality Control for Analytical Materials used in Microbiology Laboratories

 Recorded Webinar
 60 Minutes
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Quality Control for Analytical Materials used in Microbiology Laboratories

Many laboratories are unsure about which QC practices are needed and what criteria to use to assess the acceptability of the performance of analytical materials, to meet not only their requirements but also to meet the requirements of ISO/IEC 17025. During this webinar, we will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits, and reagents specifically app..

$200.00
Quality System Management Effectiveness

 Recorded Webinar
 90 Minutes
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Quality System Management Effectiveness

Quality management training will cover principles of QMS that will help your organization implement a QMS that is repeatable and efficient. A good QMS consists of standards and guidelines relating to their everyday business practices including but not limited to policies/procedures (or a Quality Manual), SOPs, and Work Instructions.It’s the common, centralized culture of quality that many people struggle wi..

$200.00
Regulatory Affairs Project Management

 Recorded Webinar
 90 Minutes
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Regulatory Affairs Project Management

This program will address approaches to regulatory affairs project management for clinical trial applications, marketing authorization applications, and ongoing management of regulatory obligations. The information obtained will enable effective management and tracking of time and resources to complete the project objectives and ensure regulatory compliance.Learning ObjectivesSetting tasks focused on projec..

$200.00
Step by Step Process for Successful Sterility Failure Investigations

 Recorded Webinar
 90 Minutes
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Step by Step Process for Successful Sterility Failure Investigations

There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, the environment, and the like. As such, there is no one size fits all investigation.  Microbiological testing covers a wide range of products, processes, an..

$200.00
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements

 Recorded Webinar
 60 Minutes
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Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your par..

$200.00
Technology Transfer 101

 Recorded Webinar
 60 Minutes
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Technology Transfer 101

This session explores the elements required for a successful technology transfer between various sites. It is intended for anyone who may be involved in the transfer of information between groups or sites. This includes both internal transfers as well as transfers to a third party. Upon completion of this session, the attendee will have a greater understanding of the process and what is required to ensure a..

$200.00
Test Method Validation – The Lifecycle Approach

 Recorded Webinar
 90 Minutes
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Test Method Validation – The Lifecycle Approach

This webinar will help personnel in the Analytical Method Development Laboratory, Quality Control Laboratory and Quality Assurance understand the evolving expectations for analytical method validation. The paradigm that test method validation is one experiment performed just before method transfer must be replaced with a proactive, lifecycle approach that includes the three stages of Analytical Method Proce..

$200.00
The Cost of Quality: How to Determine Financial Loss Through Sigma Scores

 Recorded Webinar
 60 Minutes
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The Cost of Quality: How to Determine Financial Loss Through Sigma Scores

Cost Justification: What is Your Organization’s Sigma LevelSigma Level versus dollars lost as a percent of sales is explained. By understanding your processes sigma and addressing risk properly your organization will benefit considerably. Improvement Team Selection The success of quality improvement projects will come down to the quality of the team members working on the project. Responsibilities of t..

$200.00
The FDA Inspection: Preparation, Performance and Follow-Up

 Recorded Webinar
 60 Minutes
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The FDA Inspection: Preparation, Performance and Follow-Up

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discu..

$200.00
The Human Error Tool Box: a Practical Approach to Human Error

 Recorded Webinar
 90 Minutes
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The Human Error Tool Box: a Practical Approach to Human Error

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. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrenc..

$200.00
The New Hazardous Waste General Standards

 Recorded Webinar
 90 Minutes
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The New Hazardous Waste General Standards

The hazardous waste rules including the generator standards have been in existence since 1980. In 2016, EPA recently revised the standards with the intent of simplifying the generator rules. This training will summarize new requirements, address which states the requirements are currently effective, and review the other requirements for hazardous waste generators.BackgroundHazardous Waste IdentificationChar..

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