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Tests for Outliers
Steven Wachs
60 Min
Product Id: 704404
This training program will address when to exclude outlying data points from an analysis. It will illustrate how best to apply sensitivity analysis to determine the impact of removing data. Participants will learn to perform and interpret hypothesis tests for outlier detection.
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Good Deviation Practice: What You Need to Know
John R Godshalk
60 Min
Product Id: 705293
This webinar explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations.
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Process Validation - Current Industry Practices and FDA Guidance Document Review
John R Godshalk
60 Min
Product Id: 705316
This webinar will cover basics of process validation along with current industry practices. It will also discuss recent FDA draft guidance document and the importance of good process validation.
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Drug Pharmacy Compounding
Rachelle D Souza
60 Min
Product Id: 704907
This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.
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Pharmaceutical Packaging - Regulations and Testing Standards
Thomas Feinberg
90 Min
Product Id: 705305
This webinar will present the current state of US and EU (pre-Brexit) regulatory policy with some insights into the CFDA (China) related to pharmaceutical packaging and testing. A unified risk assessment strategy will be presented to guide laboratory and eventual regulatory reporting activities.
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ICH Q11 - API Manufacturing
Peggy Berry
90 Min
Product Id: 705303
The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. By the end of this program, attendees will understand the requirements of the ICH Q11 guidance and learn skills for practical implementation of those requirements.
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Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
John R Godshalk
60 Min
Product Id: 704841
This webinar will cover what is important in facility design from the FDA and regulatory standpoint. You will understand what FDA looks for during a facility inspection. You will be able to minimize possible design errors which are difficult and expensive to fix post-build. Understand what FDA looks for in reviewing the facility design and the flow patterns.
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FDA vs Health Canada
Rachelle D Souza
60 Min
Product Id: 704862
This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.
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Creating and Maintaining an Effective and Efficient Technical Training Programs
Ginette M Collazo
90 Min
Product Id: 704373
This training program will analyze key elements of training programs in regulated environment. It will also list key performance indicators related to training and offer best practices for developing technical training programs to improve their effectiveness.
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Understanding the Basics of the FDA's New Labeling Requirements
Derrick Swint
90 Min
Product Id: 705235
The online training will offer food manufacturers a 360 degree approach to food nutritional labeling from a past, present, and future perspective.
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3-Hour Virtual Training: Lean and the Manufacturing Process
Charles H Paul
180 Min
Product Id: 705229
Lean implementation is not confined to just manufacturing. It can be appropriately applied throughout the organization in all functions. This virtual training program, however, focuses on manufacturing, where lean was born. The difference between this treatment of lean application and others is that we have imbedded the concept of GMP and compliance into our lean model to make it particularly applicable to the life sciences.
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Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies
Peggy Berry
90 Min
Product Id: 705255
This webinar will help attendees understand differences between GMP requirements for early and later stage clinical development. It will explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
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Overview of Changes in ISO 13485: 2016
Lena Cordie Bancroft
60 Min
Product Id: 704756
This training program will discuss changes from ISO 13485: 2003 to ISO 13485: 2016. Attendees will learn how to apply additional supplier controls and understand how improvement and corrective action clauses are strengthened.
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Understanding Disinfection and Cleanroom cleaning in a FDA Regulated Environment
Jim Polarine
90 Min
Product Id: 701767
This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.
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Preparing Stability Protocols for Development and Commercial Products
Peggy Berry
90 Min
Product Id: 704459
This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.
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How to Design and Implement a Dynamic Control Plan
William Levinson
90 Min
Product Id: 705171
Learn how the FMEA and control plan can be combined to create a dynamic control plan, a living document that helps to drive continual improvement.
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What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries
Rossano V Gerald
60 Min
Product Id: 705186
When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.
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GMP Training Practices to ensure Regulatory Compliance
Henry Urbach
90 Min
Product Id: 705077
By attending this webinar, you will gain a better understanding of the regulatory expectations for an effective and GMP-compliant training system. In this webinar your instructor will share with you what he has learned over the past decade of developing and delivering effective GMP training programs as well as from his 25 plus years of working in the Life Science industries.
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Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Joy McElroy
90 Min
Product Id: 704306
This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.
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Pet Food Nutrition Label Requirements
Derrick Swint
90 Min
Product Id: 705158
This course will review the basic requirements of pet food nutritional labeling, including the eight required items all pet food labels must have and the agencies that define and enforce the rules. The course will also cover frequently asked questions within the industry including guaranteed analysis and calculating calorie content. For pet food manufacturers wishing to ensure compliance to the latest nutritional labeling standard, this course offers an overview of the necessary elements to ensure compliance.