Pharmaceutical

$199.00
Stability Testing Of Pharmaceutical Products From Regulatory Perspective

 March 29 2024
 01 : 00 PM EST    
 90 Minutes
Stability Testing Of Pharmaceutical Products From Regulatory Perspective

This webinar gives a fundamental knowledge of stability testing requirements for establishing storage conditions and expiration of pharmaceutical products.Stability data form an important element of pharmaceutical regulatory submissions. This webinar will provide participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements. Also, they will be able to de..

$199.00
Understanding and Implementing a Technology Transfer Process

 April 04 2024
 01 : 00 PM EST    
 60 Minutes
Understanding and Implementing a Technology Transfer Process

Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However, the execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends on the careful development, m..

$200.00
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

 Recorded Webinar
 90 Minutes
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Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..

$200.00
Effective Batch Record Review

 Recorded Webinar
 60 Minutes
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Effective Batch Record Review

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production an..

$200.00
Equipment Qualification and Validation of Processes

 Recorded Webinar
 90 Minutes
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Equipment Qualification and Validation of Processes

The course will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. This course will provide discussion on European and FDA regulations as well as global harmonization and expectations. The course will also cover specific aspects of equipment qualification and process validation, such as protocol writing, methodology and performance, report writ..

$200.00
FDA/ ICH Guideline Q9 (R1) on Quality Risk Management

 Recorded Webinar
 90 Minutes
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FDA/ ICH Guideline Q9 (R1) on Quality Risk Management

The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application of the risk management approach outlined in the guideline, and how it relates to the pharmaceutical industry. This session will discuss some potential..

$200.00
How to Write and Manage a Change Control System

 Recorded Webinar
 60 Minutes
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How to Write and Manage a Change Control System

This webinar 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 co-ordination of all change activities will also be discussed.Areas CoveredIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate how..

$200.00
Implementing a Change Control Quality System Successfully

 Recorded Webinar
 60 Minutes
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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 ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..

$200.00
Stability Studies And Estimating Shelf Life With Regression Models

 Recorded Webinar
 90 Minutes
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Stability Studies And Estimating Shelf Life With Regression Models

Participants will be able to plan/conduct a stability study and then analyze the results to predict shelf life. They will also be able to explain the results from a statistical perspective. They will learn different approaches for estimating shelf life and will be in a position to select an appropriate method given the situation and constraints. Participants will learn how to appropriately model the data en..

$200.00
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

 Recorded Webinar
 90 Minutes
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2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..

$200.00
5S for Operators

 Recorded Webinar
 90 Minutes
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5S for Operators

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. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler..

$200.00
Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics

 Recorded Webinar
 60 Minutes
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Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics

This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (SAE) reporting requirements for OTC Drugs, Cosmetics, and Dietary Supplements. It will also cover what to expect regarding reporting changes for Cosmetics when the Personal Care Products Safety Act is passed.All OTC drugs and Dietary Supplements are required to report Serious Advers..

$200.00
Advertising and Promotional Material Compliance and Review Process

 Recorded Webinar
 60 Minutes
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Advertising and Promotional Material Compliance and Review Process

The information obtained will enable the effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, strategies for mitigating risks, and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critica..

$200.00
Answering and Replying to an FDA 483

 Recorded Webinar
 60 Minutes
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Answering and Replying to an FDA 483

A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or..

$200.00
Audit Trail Generation and Review

 Recorded Webinar
 90 Minutes
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Audit Trail Generation and Review

Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.One of the requirements for such compliance is the g..

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