Particulates in Biological Products - Evolving Regulations for Testing in Clinical and Commercial Stages
Nanda Subbarao
Product Id: 701600
This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates.
Designing Effective and Efficient Extractables or Leachables Studies for Biologics
Nanda Subbarao
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.
Auditing Business Continuity Plans According to ISO 22301
Michael C Redmond
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.
Basic Requirements for IQ, OQ and PQ Protocols
Kenneth Christie
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.
4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs
Nanda Subbarao
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.
COMPLIMENTARY WEBINAR - How to Take Control of your Credit Card Processing Fees and Save Money Without Switching Processors
Jeremy Layton
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.
Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products
Kim Huynh-Ba
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.
10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting
David Nettleton
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.
Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
Nanda Subbarao
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.
Why and How - Verification of Compendial Methods - USP <1226>
Nanda Subbarao
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.
Annual Analytical Laboratory Data Integrity Training
Nanda Subbarao
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.
Implementing Robust Supply Chains
Chris Tsai,Ron Crabtree,Buddy Baker,Betty Lane,Paula Shadle,Norman Katz,Edwin L Bills
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.
Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers
Edwin L Bills
Product Id: 700957
This pack of 2 courses contains the essentials of FDA Medical Device regulations.
Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections
Kim Huynh-Ba
Product Id: 703278
This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.
How to Buy COTS Software, and Audit and Validate Vendors
David Nettleton
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.
Key Factors to Develop an Effective CAPA System
Kim Huynh-Ba
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.
Understanding the JPAL (Japanese Pharmaceutical Affairs Law): Comprehensive Training Package (5 Courses)
Phil Smart
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.
Understanding and Preparing for System Based Inspections: Comprehensive Training Package (6 Courses)
Robert Ferer
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.