All FDA Regulated Industry

$179.00
Effective Batch Record Review

 May 26 2022
 01 : 00 PM EST    
 60 Minutes
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 a..

$179.00
Work Organized - Manage Systems

 May 26 2022
 12 : 00 PM EST    
 60 Minutes
Work Organized - Manage Systems

I will discuss four important parts of a business process (clinical study); you will gain from my description of common issues and misconceptions, their basis and remedy, and also through real live stories I provide with the four areas I discuss.Is your work well organized, according to the business process?  Areas CoveredDefinitions of data, information, security, responsibility, and their meaning, wh..

$179.00
Management Controls Under QSR and ISO 13485

 June 03 2022
 01 : 00 PM EST    
 60 Minutes
Management Controls Under QSR and ISO 13485

The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together." Since it is individuals in top management that the FDA will typically seek to fine or ..

$179.00
Method Validation of HPLC/UPLC Methods

 June 08 2022
 01 : 00 PM EST    
 60 Minutes
Method Validation of HPLC/UPLC Methods

Instrumental liquid chromatography, either as HPLC or UPLC, are a common technique in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental liquid chromatography is an analysis that is widely used to determine purity, im..

$179.00
Biomarkers in Drug Discovery and Development

 June 09 2022
 03 : 00 PM EST    
 60 Minutes
Biomarkers in Drug Discovery and Development

The potential benefits of a biomarker in drug development are very significant. Careful identification of the context of use is necessary for the successful use of a biomarker. Biomarker use could benefit individual patients participating in clinical trials (e.g., earlier identification of toxicity with a safety biomarker) or general drug development and regulatory decision-making (e.g., a prognostic or pre..

$179.00
Trends in FDA Compliance and Enforcement for Regulated Systems

 June 09 2022
 01 : 00 PM EST    
 90 Minutes
Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage, and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. As a “GxP” system, following Good Manufacturing, Laboratory, and Clinical Practices, the ..

$179.00
Understanding Aseptic Technique and Cleanroom Behavior

 June 14 2022
 01 : 00 PM EST    
 60 Minutes
Understanding Aseptic Technique and Cleanroom Behavior

Compounding sterile products are made utilizing the aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. The procedure involves the use of specialized equipment, sterile apparel, meticulous processing, and continuous cleaning.In sterile compounding, the aseptic technique is contributing to the prevention of microbiological contamination. ..

$179.00
Using Kanban JIT Systems to Run a Startup Plant

 June 21 2022
 01 : 00 PM EST    
 90 Minutes
Using Kanban JIT Systems to Run a Startup Plant

A medical device or biotechnology startup plant needs to have products available yet be agile enough to respond quickly to demand and design changes without wasting excess inventory, especially from obsolete products that did not pan out. This webinar explains how to set up and use kanbans all the way from Purchasing and Procurement, to Receiving, Receiving Inspection, Component Stock, Work Order Picking/St..

$179.00
Lockdown: Curse or Blessing

 June 30 2022
 12 : 00 PM EST    
 60 Minutes
Lockdown: Curse or Blessing

Who is needing a QMS or who doesn’t want to document how this company is managing the quality? Can I find out if my QMS is up to date with outside help (outsourcing)? Does the top management really need to start this process? Or why policy #1 is that important. Did all your PA (preventive actions) worked out well for this lockdown? How about your contingency plans? Did they have working from home, on such a..

$179.00
How FDA Trains its Investigators to Review CAPA and What Should You do to Prepare

 July 08 2022
 01 : 00 PM EST    
 60 Minutes
How FDA Trains its Investigators to Review CAPA and What Should You do to Prepare

During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by the FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by wh..

$179.00
Best Practices for Deviation Training

 July 12 2022
 01 : 00 PM EST    
 60 Minutes
Best Practices for Deviation Training

Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees, or recalls.Learning ObjectivesDiscuss what to do when problems ..

$179.00
FDA’s Technology Modernization Action Plan (TMAP) And Impact On Regulated Computer Systems And Data

 July 13 2022
 01:00 PM EST    
 90 Minutes
FDA’s Technology Modernization Action Plan (TMAP) And Impact On Regulated Computer Systems And Data

This webinar will focus on the efforts by the FDA to modernize their own technology infrastructure, and what this means to the industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by the FDA for this purpose and discuss specific actions that are planned and in progress. We will also discuss FDA’s more recent push to Software Quality Assurance (SQA) and away from tra..

$179.00
Validation of GC/GC-MS Methodologies

 July 13 2022
 01 : 00 PM EST    
 60 Minutes
Validation of GC/GC-MS Methodologies

Instrumental gas chromatography, either as GC or GC-MS, is a common technique in laboratories that do regulatory compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental gas chromatography is an analysis that is widely used to determine purity, impurities..

$179.00
Software Validation Utilizing Principles of Lean Documents and Lean Configuration

 July 19 2022
 01 : 00 PM EST    
 90 Minutes
Software Validation Utilizing Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. New approaches to software validation will help avoid many of the structural costs with a major endeavor by removing legacy methods that applied to paper systems. This will also set the stage for further integratio..

$179.00
GMP Audits: Tools and Techniques

 July 28 2022
 02 : 00 PM EST    
 60 Minutes
GMP Audits: Tools and Techniques

The extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal and external GMP audits in order to find and correct areas where sites are not in full compliance with the GMP regulations before an FDA audit occurs. By providing proper tools and techniques to be used during a GMP audit. The auditor can begin to understand the areas wh..

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