WEBINARS

 

Regulations & Guidances Compliance Training - Live Webinars, Recordings & CDs

Challenges of an Effective Change Control Program

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 704638

This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.

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

 

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

 

Stability Program for Pharmaceuticals and Biologics

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 705455

This webinar will provide an overview of the stability studies required for pharmaceuticals and biologics. It will also provide a summary of recent developments in the industry and regulatory requirements in this field.

Recording Available

 

Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 705081

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.

Recording Available

 

The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications

webinar-speaker   David Nettleton

webinar-time  

Product Id: 704734

This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.

Recording Available

 

Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 704770

Upon completion of this training program, attendees will learn key factors that would affect the shipping and distribution of drug products. One must understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping conditions in order to maintain quality of the drug product through expiry.

Recording Available

 

Establish an Effective Change Management Process for Stability Studies

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 704085

Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.

Recording Available

 

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

webinar-speaker   Phil Smart

webinar-time  

Product Id: 701292

This (JPAL) Japanese Pharmaceutical Affairs Law training will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese.

Recording Available

 

Current Regulatory Requirements for Aseptically Produced Products

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 704791

The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few. A weakness in any of these items can jeopardize the sterility assurance of the final product. This training program will highlight and summarize the following main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

Recording Available

 

Establish Change Control for Pharmaceutical Stability Program

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 702968

This webinar on pharmaceutical stability program will discuss the types of CMC changes in the life cycle of a pharmaceutical product and how it affects the stability program.

Recording Available

 

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