Validation of Bioanalytical Methods and Procedures for FDA Compliance

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 702229

This Validation of Bioanalytical Methods and Procedures training will demonstrate how to validate bioanalytical methods and procedures, in analytical laboratories, for FDA compliance.

Recording Available

* Per Attendee $149

 

Dissolution Instrument Qualification to Meet Requirements and Minimize Product OOS Dissolution Results

webinar-speaker   Gregory Martin

webinar-time   120 Min

Product Id: 701917

This 2-hr Dissolution Instrument Qualification webinar will discuss recent FDA requirements for dissolution instrument qualification and provide practical suggestions to avoid pitfalls in performance of the tests, minimize Performance Verification Test and product failures.

Recording Available

* Per Attendee $249

 

4-hr Virtual Seminar: Using the USP Effectively

webinar-speaker   Gregory Martin

webinar-time   3.2 hrs

Product Id: 702019

This 4 hour virtual seminar will provide a solid understanding of the USP, its sections and how they are inter-related. Attendees will also learn how to be aware of changes to the USP, and how to influence them.

Recording Available

* Per Attendee $999

 

Avoiding Failure to Investigate - Observations by Conducting Effective Investigations

webinar-speaker   Felicia Ford-Rice

webinar-time   49 Min

Product Id: 701933

This webinar will focus on the key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Failure to Investigate" Observations by FDA.

Recording Available

* Per Attendee $449

 

Auditing Analytical Laboratories for FDA Compliance

webinar-speaker   Michelle Sceppa

webinar-time   60 Min

Product Id: 701325

This Analytical laboratory audit training/webinar will show how to implement a GXP program and how to audit this program.

Recording Available

* Per Attendee $199

 

Ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities

webinar-speaker   Frank Settineri

webinar-time   90 Min

Product Id: 701145

This Microbiology training/webinar will provide a new approach in ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities.

Recording Available

* Per Attendee $199

 

Good Laboratory Practices (GLP): Documenting Deviations & Unexpected Circumstances

webinar-speaker   Celeste Rose

webinar-time   60 Min

Product Id: 701246

This Good Laboratory Practice training defines deviations and unexpected events, the similarities and differences between deviations and amendments, and will present strategies to minimize the occurrence of unnecessary deviations.

Recording Available

* Per Attendee $249

 

Maintenance and Calibration of Equipment

webinar-speaker   Michelle Sceppa

webinar-time   60 Min

Product Id: 701188

This Pharmaceutical compliance training will provide instruction on how to establish and maintain a Maintenance & Calibration program for pharmaceutical instrumentation & equipment.

Recording Available

 

Analytical Instrument and Equipment Qualification in GXP and EPA Laboratories: USP 1058 and Beyond

webinar-speaker   Richard Poser(PhD)

webinar-time   90 Min

Product Id: 701120

This Laboratory compliance training will review the regulations that cover each environment and present simple and effective strategies for satisfying the requirements. The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP (Good Laboratory Practices) labs supporting animal toxicology studies and GCP (Good Clinical Practices) labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated.

Recording Available

* Per Attendee $299

 

Clearing up Roles and Responsibilities in the GLPs

webinar-speaker   Anne E Maczulak

webinar-time   60 Min

Product Id: 701092

This GLP (Good Laboratory Practices) webinar presents a straightforward summarization of the roles and responsibilities of all the people that contribute to a GLP study.

Recording Available

* Per Attendee $299

 

Contamination Control 101 in Pharmaceutical, Biotech, and Medical Device Clean rooms

webinar-speaker   Jim Polarine

webinar-time   90 Min

Product Id: 701023

This Contamination-Control training will provide valuable assistance to companies that need to validate their cleaning and disinfection programs.

Recording Available

* Per Attendee $299

 

Investigating Out of Specification Guidance (OOS) in the Laboratory

webinar-speaker   Michelle Sceppa

webinar-time   60 Min

Product Id: 701127

This Pharmaceutical training provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits.

Recording Available

* Per Attendee $249

 

Deviations and Process Failures within a CAPA program

webinar-speaker   Michelle Sceppa

webinar-time   40 Min

Product Id: 701096

This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements. Many regulated companies still do not have a robust Failure Investigation and/or CAPA programs. Failure investigations and Corrective and Preventive actions (CAPA) are amongst the most frequently found deviations in FDA warning letters. Companies have procedures but either they are not adequate or are not followed. This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements.

Recording Available

* Per Attendee $149

 

Best Practices in GLP Final Reporting and Study Closure

webinar-speaker   Anne E Maczulak

webinar-time   60 Min

Product Id: 701091

This GLP (Good Laboratory Practices) webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. The GLP final study report represents the last chance for a study team to present their results in a clear and compelling manner. The report may also be a place where difficulties can be explained so that the study provides meaningful and trustworthy information. This webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. It provides two areas of concentration: (1) the best practices in final report writing and (2) the step-by-step process of closing studies.

Recording Available

* Per Attendee $299

 

Small GMP problems which cause the biggest enforcement headaches: how to tackle them

webinar-speaker   Steven S Kuwahara

webinar-time   75 Min

Product Id: 700950

The presentation will use examples taken from warning letters to illustrate some of these problems, and discuss possible solutions. As an example, we will discuss the process for accepting raw material.

Recording Available

* Per Attendee $249

 

ISO 17025 - The elements of good management system for the competence of testing and calibration in laboratories

webinar-speaker   Lawrence Mucha

webinar-time   60 Min

Product Id: 700919

This presentation will cover sections 4 and 5. These contain the requirements for accreditation. ISO 17025 “describes” the elements of a good management system for a laboratory. It also details the principles for a laboratory to ensure technical competence.

Recording Available

* Per Attendee $249

 

The CAPA Trap or Common Problems and Pitfalls

webinar-speaker   Jeff Phillips

webinar-time   60 Min

Product Id: 700914

The following webinar will cover common CAPA problems across industries and how to avoid them. This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA.

Recording Available

* Per Attendee $249

 

GLP Compliance Audits: What to look out for at a New Nonclinical CRO

webinar-speaker   David Pepperl

webinar-time   60 Min

Product Id: 700853

This webinar will discuss how to perform pre-study GLP compliance audits and what to look for at candidate nonclinical CRO This webinar will be valuable for any member of a pharmaceutical or biotechnology organization charged with placing or monitoring nonclinical GLP safety studies.

Recording Available

* Per Attendee $249

 

Introduction to statistical Design and Analysis of Experiments (DOE)

webinar-speaker   Lawrence Mucha

webinar-time   60 Min

Product Id: 700344

This statistical Design and Analysis of Experiments webinar will introduce DOE and process modeling.

Recording Available

* Per Attendee $249

 

Training Requirements and Practices to Assure QSR and ISO Compliance

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700316

This Medical device training will instruct on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training. To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them.

Recording Available

* Per Attendee $249

 

 

 

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