Biotechnology

$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..

$179.00
Quality Systems Inspection Technique (QSIT), And How to Use It To Your Advantage

 August 05 2022
 01 : 00 PM EST    
 60 Minutes
Quality Systems Inspection Technique (QSIT), And How to Use It To Your Advantage

This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need to understand the methodologies used by FDA during inspections. During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used ..

$179.00
Method Validation Under Good Laboratory Practices (GLP)

 August 10 2022
 01 : 00 PM EST    
 60 Minutes
Method Validation Under Good Laboratory Practices (GLP)

Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees the validity of results. If you work in pharmaceuticals, chemicals, and petrochemicals, and environmental analyses then you are mandated to be following GLP. One of the major tasks in GLP is the validation of an analytical method.The new pharmaceutica..

$179.00
Conducting a Successful Supplier Audit

 August 16 2022
 01 : 00 PM EST    
 60 Minutes
Conducting a Successful Supplier Audit

When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge..

$179.00
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

 August 18 2022
 01 : 00 PM EST    
 90 Minutes
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..

$179.00
Medical Device Software Per IEC 62304

 August 23 2022
 01 : 00 PM EST    
 60 Minutes
Medical Device Software Per IEC 62304

This course is essential for medical device companies interested in submitting software-enabled medical devices or software as a medical device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and no..

$179.00
Best Practices in Preparation for an FDA Computer System Audit

 September 05 2022
 01 : 00 PM EST    
 90 Minutes
Best Practices in Preparation for an FDA Computer System Audit

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it ..

$179.00
Monitoring a Quality Laboratory to Prevent Non-Compliance

 September 07 2022
 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
Objectionable Microorganisms in Pharmaceutical Manufacturing

 September 08 2022
 02 : 00 PM EST    
 60 Minutes
Objectionable Microorganisms in Pharmaceutical Manufacturing

Objectionable microorganisms are considered if discovered, harmful to the patient. By identifying and controlling these microorganisms, then putting the appropriate controls place early in the pharmaceutical manufacturing or medical device manufacturing process problems in the patient can be prevented. This webinar will review the regulations pertaining to objectionable microorganisms, agency expectations, ..

$179.00
Proper Management of Regulatory Agency Inspections

 September 13 2022
 01:00 PM EST    
 60 Minutes
Proper Management of Regulatory Agency Inspections

The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Many times, the arrival of a Regulatory Investigator is a daunting experience for some. In this webinar, ..

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