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Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>
Gregory Martin
90 Min
Product Id: 705325
This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.
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Transfer of Analytical Methods According to the USP Chapter <1224>
Dr. Ludwig Huber
75 Min
Product Id: 701971
This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.
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Troubleshooting Ethylene Oxide (EO) Processes
Gerry O Dell
60 Min
Product Id: 701679
This EO sterilization training Webinar will discuss the important parameters to measure for the sterility assurance level and actions to take if they are not compliant to the process specification.
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ICH Stability Requirements and Challenges
Wayland Rushing
60 Min
Product Id: 704585
This training program will detail the requirements for ICH stability studies, discuss how to design stability programs for your drug product, and list analytical methods requirements. It will also focus on how to interpret the data generated by the stability programs.
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Understanding and Controlling Endotoxin in Water Systems
T.C Soli
60 Min
Product Id: 701301
This Water system compliance training cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water.
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5-hr Virtual Seminar: Qualification and Control of Suppliers and Contractors for Pharmaceutical and Medical Device Industries
Howard Cooper
5 hrs
Product Id: 702128
This training on qualification and control of suppliers and contractors in the medical devices and pharmaceutical industry will review compliance requirements, the qualification cycle, the key steps involved in it, including the audit process, use of audit tools and evaluation to decide on qualification/ disqualification.
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Gaining and Re-Establishing Control of Your Cleanroom
Jim Polarine
60 Min
Product Id: 702333
This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
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Computer System Validation: Step-by-Step
Dr. Ludwig Huber
75 Min
Product Id: 701673
Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, and structure of validation report.
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Medical Device Tracking Requirements
Vanessa Lopez
60 Min
Product Id: 705192
Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.
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Good Laboratory Practice Regulations
Dr. Ludwig Huber
75 Min
Product Id: 700204
This GLP webinar training will discuss the various US and International GLP regulations and the strategies to comply with them. Get practical recommendations from industry leading expert Dr. Ludwig Huber.
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Conducting Effective Quality Audits: Beyond Audit Checklists
Andrew Campbell
60 Min
Product Id: 703539
This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.
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How to Transition from Paper to Electronic Records in a Regulatory Environment
Charlie Sodano
75 Min
Product Id: 703576
This webinar will cover effective and efficient ways to transition from paper to electronic records in a regulated environment. It will address compliance issues, complexity in decision making and implications specific to the pharmaceutical industry.
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Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components
Howard Cooper
115 Min
Product Id: 701944
This training will help you understand FDA expectations for reduced testing of Pharmaceutical & Medical Device components and will develop your confidence in maintaining control of supplier quality.
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Laboratory Investigations for Out of Specification Results
Barbara Berglund
90 Min
Product Id: 702263
This 90-minute webinar on laboratory investigations will explore successful approaches to laboratory investigations of out of trend results and also explore approaches which may have potential for pitfalls.
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Understanding Disinfectant Qualification Studies - How to avoid errors
Jim Polarine
90 Min
Product Id: 702210
This 90-minute webinar on Disinfectant Qualification Studies will teach you disinfectant testing methodologies, provide examples of disinfectant efficacy tests and show how to troubleshoot problems related to disinfectant efficacy testing.
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Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?
Peggy Berry
60 Min
Product Id: 705349
This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.
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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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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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System Suitability Testing (SST) for USP and FDA Compliance
Dr. Ludwig Huber
75 Min
Product Id: 702512
Amid several other critical discussions, this training program will detail FDA and international requirements for system suitability testing; SST in comparison with equipment qualification and quality control sample analysis; critical parameters for SST in EP and USP; recommendations for implementing the updated <621>; and developing an SOP for system testing.
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Water System Investigation "How-To's" and Example Case Studies
T.C Soli
90 Min
Product Id: 701585
In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process.