Approaching Unknown Cause Laboratory Investigations Using Lean Tools
Barbara Berglund
60 Min
Product Id: 701905
Understand the requirements for investigations when dealing with pharmaceutical drug substances and products; to understand how to effectively control and conduct a laboratory investigation for unknown causes.
Does your QC lab do GMP and non-GMP activities?
Barbara Berglund
60 Min
Product Id: 701844
In this 1-hr webinar you will learn how to differentiate and draw boundaries for GMP and GLP practices if done in same laboratory and how to transition a procedure in development to one used routinely.
How to undergo an FDA Inspection Successfully
Marie Morin
90 Min
Product Id: 705170
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
How to Prepare for the New EU Medical Device Regulations
Richard Young
90 Min
Product Id: 705513
The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.
Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge
Jeff Kasoff
60 Min
Product Id: 701788
This Medical device complaints handling webinar will discuss the best practices of complaint handling and how to include it in your CAPA program and how to apply risk management to the complaint handling system.
Building a Vendor Qualification Program for FDA Regulated Industries
Jonathan M Lewis
60 Min
Product Id: 703467
This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.
Change Control Best Practices: Avoiding Unintended Consequences of Changes
Andrew Campbell
90 Min
Product Id: 703540
This webinar will provide an overview of regulatory requirements for change control. It will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc.
Laboratory Accreditation: Getting there is Just the Beginning
Michael Brodsky
60 Min
Product Id: 703285
This training on laboratory accreditation will focus on ISO/IEC 17025 requirements. Attendees will learn how to develop and maintain a quality management system to ensure compliance with the international laboratory accreditation standard.
Remediating Water System Biofilm - What to Do After It Gets Ahead of You
T.C Soli
90 Min
Product Id: 702860
This pharmaceutical water systems webinar training will discuss what you should do when your monitoring data tells you that you may have a significant biofilm problem. It covers how to verify that the data and your interpretation of the data are correct, as well as the location of the problem which gives you clues as to what caused the problem and its impact on manufacturing and product.
How to Analyze PQ Data with Multiple Populations/ Failure Modes using Minitab®
Jerry Phillips
90 Min
Product Id: 705281
This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.
Safe Drinking Water - Another Oxymoron?
Michael Brodsky
60 Min
Product Id: 703944
This training program will discuss the sources and causes of waterborne disease and what microbial options are available to assess and minimize the risk.
Understanding and Implementing USP <1058>: Analytical Instrument Qualification
Dr. Ludwig Huber
75 Min
Product Id: 700067
This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation.
Leadership in Manufacturing Contamination Control: The Microbiology Lab
T.C Soli
60 Min
Product Id: 701478
This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.
Sampling Plan for Quality Audits
Daniel O Leary
90 Min
Product Id: 702581
This webinar examines the issues in audit sampling and provides the answers one need to plan audit. It will help attendees understand the use of standard sampling plans in an audit including FDA’s QSIT sampling plans.
Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations
Jim Polarine
90 Min
Product Id: 701766
This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations.
You have a BI or Sterility Failure - Now What?
Gerry O Dell
90 Min
Product Id: 701503
This webinar on sterility or bioburden test for medical devices will discuss about the various items that should be investigated to determine the root cause, when a failure occurs during a sterility test, and the follow up to the investigation.
Classifying Medical Devices - US and EU
Charles H Paul
60 Min
Product Id: 705045
The Medical Device Classification webinar explains the classification system in US and the EU.
Nutrition and Health Claims Regulation (NHCR) in the European Union
Vicente Rodriguez
60 Min
Product Id: 705492
This webinar on Nutrition and Health claims (NHCR) will provide guidance to any food business operator intending to present food products as having nutritional or health benefits should be aware of the legal possibilities and limitations that the EU system offers.
Validation of Complex Cell-Based Potency Methods
Gwen Wise Blackman
60 Min
Product Id: 705172
Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation.
Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration
Jose Mora
90 Min
Product Id: 703373
This webinar will explain how to create, develop and manage Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods.