Coping with a Difficult Compliance Officer when Responding to a 483, Warning Letter, Import Alert or Recall

webinar-speaker   Marc Sanchez

webinar-time   60 Min

Product Id: 703044

This webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions.

Recording Available

* Per Attendee $229

 

Essential Last Minute Preparation for an Imminent FDA Inspection

webinar-speaker   Chris Cook

webinar-time   60 Min

Product Id: 703004

This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.

Recording Available

* Per Attendee $229

 

Analytical Test Methods Validation: FDA, ICH and USP Requirements

webinar-speaker   Richard Poser(PhD)

webinar-time   90 Min

Product Id: 701122

This method validation training will address the regulatory requirements which apply at the various stages of product development, and suggest proven strategies for compliant and phase-appropriate analytical method validation.

Recording Available

* Per Attendee $159

 

FDA and Social Media - How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws and Regulations

webinar-speaker   Mark Gardner

webinar-time   90 Min

Product Id: 702907

This webinar on FDA social media regulations will discuss the best practices utilized by medical device, drug and other FDA and FTC regulated industries when using social media channels, i.e., Web 2.0, like Facebook, Twitter, YouTube and LinkedIn to promote products.

Recording Available

* Per Attendee $229

 

New QC Based on Risk Management: A Collaboration between CLIA and CLSI

webinar-speaker   Pamela Tayon Colker

webinar-time   60 Min

Product Id: 702385

This lab quality compliance training will provide a comprehensive overview of the Clinical and Laboratory Standards Institute (CLSI) Laboratory Quality Control Based on Risk Management; Approved Guideline, EP-23-A, produced in partnership with the Clinical Laboratory Improvement Amendment (CLIA).

Recording Available

* Per Attendee $229

 

The Sunshine Act Final Rule

webinar-speaker   Mark Gardner

webinar-time   120 Min

Product Id: 702825

This session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.

Recording Available

* Per Attendee $249

 

How to Make GMP Training Fun and Engaging

webinar-speaker   Grimoalda Botelho

webinar-time   60 Min

Product Id: 702808

This session on conducting effective GMP trainings will cover proven learning techniques for technical and compliance related trainings. It will answer key questions about how to make GMP training sessions more engaging and even fun for the learners in your organization.

Recording Available

* Per Attendee $50

 

Auditing the QC Microbiology Laboratory for FDA Compliance

webinar-speaker   Chitra Edwin

webinar-time   75 Min

Product Id: 701364

This microbiology laboratory training will provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance, test failures and resolution of audit findings.

Recording Available

* Per Attendee $349

 

FDA Warning Letters - Stop Fumbling your Response and Effectively Demonstrate Compliance

webinar-speaker   Marc Sanchez

webinar-time   60 Min

Product Id: 702797

This training will outline the best practices in responding to a FDA Warning Letter so the consequences of the findings do not escalate beyond the current status.

Recording Available

* Per Attendee $229

 

GLP and Compliance for a Clinical Laboratory's Incident Management Plan

webinar-speaker   Pamela Tayon Colker

webinar-time   60 Min

Product Id: 702752

This GLP training will guide you in developing your laboratory's incident management plan to ensure that your laboratory policies and procedures are in compliance and your patients, visitors and staff are protected from accidents or unexpected events.

Recording Available

* Per Attendee $229

 

Using Electronic and Digital Signatures in Regulated Environments

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 702672

This webinar will familiarize you with FDA requirements for electronic and digital signatures, and the agency's inspection and enforcement practices. Particpants will recieve complimentary hand-outs for easy implementation.

Recording Available

* Per Attendee $229

 

Microbiological Sampling of Foods

webinar-speaker   Jim Dickson

webinar-time   60 Min

Product Id: 702659

This webinar on microbiological sampling for foods will address fundamental approaches to sampling, from raw materials to finished products. Topics will include sampling plans, sample collection methods and chain of custody issues. A primary focus will be on interpretation of results, based on the limitations of sampling plans and microbiological methods.

Recording Available

* Per Attendee $229

 

Personnel Practices and Microbial Control in Pharmaceutical, Biotech, and Medical Device Manufacturing

webinar-speaker   Jim Polarine

webinar-time   90 Min

Product Id: 702446

This 90-minute webinar on personnel practices and microbial control in Pharmaceutical, Biotech, and Medical Device manufacturing will cover effective ways to train personnel on gowning and personnel practices in cleanroom operations to limit contamination. This webinar will also address controlling microorganisms on process equipment and product contact surfaces.

Recording Available

* Per Attendee $229

 

Test Article Management and Characterization for Drugs and Devices

webinar-speaker   Anne E Maczulak

webinar-time   90 Min

Product Id: 702337

This 90-minute webinar will clarify your confusion about Test Article Characterization for GLP drug studies. You will learn the correct way to use GMP characterization data in a GLP study, understand how to characterize a medical device as a test article, learn the common mistakes made in test article characterization and the basic requirements for drug and device stability testing.

Recording Available

* Per Attendee $229

 

Eliminate the Confusion - Analytical Method Qualification and Validation

webinar-speaker   Melissa Smith

webinar-time   60 Min

Product Id: 702314

This webinar will help you understand the significant differences between qualification and validation of an analytical method, the expectations and requirements of each, and their place in the analytical method lifecycle.

Recording Available

* Per Attendee $149

 

Understanding and Implementing ISO 17025

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 700989

This webinar will provide a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation. You will learn steps towards laboratory accreditation and how to prepare for an ISO 17025 audit.

Recording Available

* Per Attendee $50

 

Good Laboratory Practices for Bioanalytical Laboratories

webinar-speaker   Anne E Maczulak

webinar-time   90 Min

Product Id: 702338

This 90-minute webinar will help you to develop a sound bioanalytical process to ensure quality data. It will cover techniques for bioanalytical data management for the purpose of assuring a regulatory agency that the data have been collected, managed, and archived to the highest standards of quality assurance. You will understand the aspects of bioanalysis that can be run according to GLPs and the aspects in which GLPs do not apply.

Recording Available

* Per Attendee $229

 

Ethics and Scientific Misconduct in Regulated Studies

webinar-speaker   Anne E Maczulak

webinar-time   60 Min

Product Id: 702343

This webinar discusses the high risks of scientific misconduct in regulated studies. You will understand the main issues in producing study results of the highest integrity, learn how managers can implement a system for ensuring accurate and reliable data, understand the "red flags" of questionable data or reporting and develop a plan for identifying the high-risk steps in your operation.

Recording Available

* Per Attendee $229

 

HPLC Method Development and Validation

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 702269

This webinar on HPLC Method Development and Validation will outline similarities and differences in validations, and regulatory requirements, outline approaches specific to HPLC and to the various hyphenated detections systems.

Recording Available

* Per Attendee $149

 

Archiving GLP Records: How Archiving Makes or Breaks the Audit

webinar-speaker   Anne E Maczulak

webinar-time   60 Min

Product Id: 701505

This webinar on archiving GLP records will discuss the options for managing large archiving facilities to small facilities with one-room archives. You will receive practical tips on how to correct mistakes that agencies have cited regarding archiving.

Recording Available

* Per Attendee $349

 

 

 

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