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Ten Keys for Maximizing the Benefits of your SPC Program
Steven Wachs
75 Min
Product Id: 705751
This Statistical process control webinar will discuss the 10 elements which will enable any company to improve their SPC and realize the benefit. It will discuss how to identify and use right systems, charts, controls limits, sampling and what process improvements required to achieve more from your SPC program.
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Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience
John R Godshalk
60 Min
Product Id: 704806
This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity
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Internal GMP Audit Program - Execution and Communication
Ronald Torlini
60 Min
Product Id: 705750
This webinar will discuss the steps to execute internal GMP Audit, how to get all departments for acceptance and how to communicate audit findings specifically when it is serious and quality needs confirmation of acceptance and resolution.
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Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions
Andrew Campbell
90 Min
Product Id: 703538
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
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Good Manufacturing Practices and Audit Best Practices
Rama Rao
90 Min
Product Id: 705745
This webinar will discuss the fundamentals requirements for system which gets audited during FDA inspection and how to conduct internal audit, report writing and audit follow ups.
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Setting Specifications for Drug Substances and Drug Products
Peggy Berry
90 Min
Product Id: 704859
This 90-minute training will discuss the requirements of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Attendees will also learn the requirements for changing specifications through the lifecycle of the product.
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Cybersecurity: Safeguard Your Organization Against Cybercrime
Angela Bazigos
90 Min
Product Id: 705642
This cybersecurity course will teach you how to safeguard your organisation against cybercrime. By attending this webinar you will understand the new technologies, challenges and cybersecurity trends. It will also discuss the future trends and expectations.
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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.
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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.
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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.
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FDA Communication Power Tools – Best Practices
Kwame Ulmer
60 Min
Product Id: 705667
This FDA communication best practices webinar will discuss the best practices for communication with FDA staff, general timing of communications, how to deal with deficiencies and key resources for premarket applications and post market communications.
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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.
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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.
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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.
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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.
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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.
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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.
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FSMA Foreign Supplier Verification
Bryan Armentrout
60 Min
Product Id: 704952
This webinar will teach you what is expected under the new requirements of the Food Safety Modernization Act. Every food company that manufactures or supplies food under FDA jurisdiction is now or will be required to have a Foreign Supplier Verification Program in place.
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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.
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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.