WEBINARS

 

Compliance Training Webinars for Regulated Industries

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How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities

webinar-speaker   Michael C Redmond

webinar-time  

Product Id: 704991

This training program will discuss how to develop a great GRC program that ensures proper governance, risk management and compliance management of all IT systems and processes that support the business operations.

Recording Available

 

NCMR Simplified - A one-form, easy-to-complete, method for simplifying your NCMR Process

webinar-speaker   Denise Wrestler

webinar-time   90 Min

Product Id: 705876

In this presentation attendees will understand the FDA regulations (21 CFR Subpart I) regarding NCMR, how NCMR should be integrated into your CAPA system, how to best approach NCMR (including initiation, segregation, evaluation, investigation, notification, and disposition), examples of documentation you can use to fulfill the NCMR requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. It will also highlight additional tips and tricks on how to convey the importance of NCMR within your organization and ensure resources are provided to meet process needs.

Recording Available

 

Particulates in Biological Products - Evolving Regulations for Testing in Clinical and Commercial Stages

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 701600

This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates.

Recording Available

 

Designing Effective and Efficient Extractables or Leachables Studies for Biologics

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 701591

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.

Recording Available

 

Auditing Business Continuity Plans According to ISO 22301

webinar-speaker   Michael C Redmond

webinar-time  

Product Id: 704410

This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.

Recording Available

 

Basic Requirements for IQ, OQ and PQ Protocols

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 704591

This training program will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. It will highlight the importance of establishing specifications for all test challenges, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.

Recording Available

 

4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 704730

This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.

Recording Available

 

COMPLIMENTARY WEBINAR - How to Take Control of your Credit Card Processing Fees and Save Money Without Switching Processors

webinar-speaker   Jeremy Layton

webinar-time  

Product Id: 705207

If your company processes over $50,000 in credit card volume per month, this webinar will explain certain strategies that will help reduce the processing fees you are charged.

Recording Available

 

Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 704421

This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.

Recording Available

 

10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting

webinar-speaker   David Nettleton

webinar-time  

Product Id: 701583

Understand the 10-step risk based approach to validation, explore methods to decrease resource requirements, and learn how to make documentation more manageable and understandable.

Recording Available

 

Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 701748

This 90-minute training will provide you with an overview of a forced degradation study on a protein therapeutic and help you interpret and leverage the results to design stability studies required for registration of the BLA.

Recording Available

 

Why and How - Verification of Compendial Methods - USP <1226>

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 701752

This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. We will discuss FDA 483s on the subject of Method Verification to understand current FDA expectations.

Recording Available

 

Annual Analytical Laboratory Data Integrity Training

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 705326

This webinar will address the key elements of regulatory expectations for analytical laboratory data integrity. It will teach best practices to avoid 483s and warning letters issued by FDA related to data integrity issues.

Recording Available

 

Implementing Robust Supply Chains

webinar-speaker   Chris Tsai,Ron Crabtree,Buddy Baker,Betty Lane,Paula Shadle,Norman Katz,Edwin L Bills

webinar-time   8.5 hrs

Product Id: 702793

This comprehensive training package of 7 courses is aimed at helping companies to be compliant and streamline the robust supply chain planning, processes, risk management etc by maintaining regulatory guidelines.

Recording Available

* Per Attendee $1649

 

Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers

webinar-speaker   Edwin L Bills

webinar-time  

Product Id: 700957

This pack of 2 courses contains the essentials of FDA Medical Device regulations.

Recording Available

* Per Attendee $349

 

Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 703278

This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.

Recording Available

 

How to Buy COTS Software, and Audit and Validate Vendors

webinar-speaker   David Nettleton

webinar-time  

Product Id: 703820

This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.

Recording Available

 

Key Factors to Develop an Effective CAPA System

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 703320

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

Recording Available

 

Understanding the JPAL (Japanese Pharmaceutical Affairs Law): Comprehensive Training Package (5 Courses)

webinar-speaker   Phil Smart

webinar-time  

Product Id: 701294

This package of 5 training courses is meant to give an exhaustive and in-depth understanding of the Japanese Pharmaceutical Affairs Law (PAL) including the 2005 revisions which are now in force.

Recording Available

 

Understanding and Preparing for System Based Inspections: Comprehensive Training Package (6 Courses)

webinar-speaker   Robert Ferer

webinar-time  

Product Id: 701357

This System Based Inspections training will give you a comprehensive overview of all aspects of systems based inspections covering Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling and Laboratory Control.

Recording Available

 

 

 

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