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.
Product Id: 703278
This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.
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.
Understanding the JPAL (Japanese Pharmaceutical Affairs Law): Comprehensive Training Package (5 Courses)
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)
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.
Product Id: 703041
This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.
John J Meola
Product Id: 705470
This webinar will review the most critical safety elements associated with planning for, surviving and recovering from natural disasters, such as Hurricane Harvey we have seen recently in Texas. Learn how to protect yourself, your family and your employees, what to expect, and how to minimize the disruption from severe weather events.
Barry A Friedman
Product Id: 705452
This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.
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.
Michael C Redmond
Product Id: 704821
This training program will provide an overview on how to create a business continuity audit plan that is effective and in line with the company's objectives. It will help attendees understand regulations, standards and requirements pertinent to business continuity audits as well. The webinar will define the risks or threats to the success of an audit plan and train attendees on how to test the controls in place to determine whether or not those risks are acceptable.
Michael C Redmond
Product Id: 704827
This webinar highlights the importance of an effective ERM program in project management and risk assessment. Attendees will learn how to implement a viable ERM program including documenting and testing it.
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.
Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to Meet ICH Requirements
Product Id: 701594
This webinar will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures.
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.
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.
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.
Webinars Series on Water System Compliance for Consumer Products, Medical Devices, Diagnostics, Pharmaceuticals, and Biologics
Product Id: 701351
This Water system compliance training will give you a comprehensive knowledge about water system compliance with relation to Microbial Quality Problems, Microbial Testing, Endotoxin control, Sanitization, Water system validation.