Food, Drugs & Biologics
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Regulatory Issues in Pharmacogenomics
Description: This presentation will begin by giving an overview of Pharmacogenomics and how it is used in drug development. It will then identify the agencies that regulate Pharmacogenomics data, and explain what the regulations are. It will then go... -
Good Clinical Practices
Description: Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws... -
Incorporating Risk Management into Process Improvement
Description: CBS Newsman Eric Sevareid once said, “The chief cause of problems is solutions.” Every organization engages in process improvement activities, but too often, these activities also have unintended negative consequences. A small mistake can cost a company millions... -
Calibration and Assuring Accurate Measurements
Description: Assuring accurate measurements is important when establishing specifications during product design and development, during process validation and for assuring product performance while testing for lot release. Assuring accurate measurements accounts for a significant amount of time and resources... -
Verification vs Validation
Description: This webinar will focus on the difference between Verification vs Validation and how can we use them to improve the bottom line. If Verification &Validation are done right, the process and product should always conform unless there is... -
Clean Room Design and Operation
Description: Controlled environmental conditions are often used when making medical devices and pharmaceuticals. However, to make sure these clean rooms are continuously operating in a state of control can be a difficult task unless the appropriate controls are incorporated... -
Quality Auditing for Added Value and Continuous Improvement
Description: Oh no! The auditor is coming this week! Whether it is the FDA or an important customer or the Corporate Compliance Group, even pre-announced visits by these outside auditors can induce strain, apprehension and/or outright fear in many... -
Benchmark for Cleaning Validation and Control
Description: Cleaning validation is increasingly important in preventing cross contamination and interactions between active ingredients in subsequent batches run in the same equipment. This webinar will review principles of sterilization validation and using them as a benchmark for more... -
Root Cause Analysis – Shutting Down the Alligator Farm
Description: This webinar is applicable to all levels as it covers underlying principles (which are often overlooked in basic and intermediate courses) in a simplified format that does not require previous familiarity with using the tools. A well-functioning Corrective... -
Good Practices in Preparing for an FDA Inspection Preparation with Awareness: Do’s and Don’ts
Description: This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection in an actionable, sustainable manner with improved awareness. If a firm is subject to FDA regulations, they should be... -
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Investigator initiated trials- What are we doing to ensure human subject protection ?
Description: This 1 hour virtual seminar will help you understand the key issues and challenges associated with investigator initiated trials. Investigator initiated trials are very important as they are important connection for the translation of research from bench to... -
Risk Management and Risk Analysis Techniques in Clinical Trials
Description: If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this seminar will provide you with an overview of risk factors in clinical trials and possible ways to mitigate, control, assess... -
Quality Lean Auditing
Description: The competitive market and the business goal for growth are some of the variables that dictate optimization of resources, including an effective quality audit program (system, product or process). Audit findings that can trigger measurable action plan, measurable... -
Confidence / Reliability Calculations & Statistically Valid Sample Sizes
Description: All manufacturing and development companies perform testing and/or inspections that involve concluding whether or not a product or lot is acceptable vs. design or QC specifications. Such test/inspections may occur during design verification/validation or during incoming or final... -
Statistical Analysis of Gages
Description: The seminar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and “uncertainty ratios”. Several of the standard methods for analyzing measurement variation are then described and explained, as... -
Statistical Process Control (SPC)
Description: All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The...
