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Process Capability Analysis, and What to Do if it's Not a Bell Curve
William Levinson
60 Min
Product Id: 705157
This process capability analysis webinar will discuss the relationship between variation and accuracy, and process yield, short term versus long term variation, non-normal distributions and how to perform a process capability study.
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3-Hr Virtual Training: Introduction to Design of Experiments
Steven Wachs
3 hrs
Product Id: 704847
In this training program, attendees will understand when and why to apply DOE (design of experiments). They will also learn to identify and interpret significant factor effects and 2-factor interactions and develop predictive models to explain and optimize process/product behavior. Applying efficient fractional factorial designs in screening experiments will also be discussed.
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Understanding and Implementing a Technology Transfer Process
Steven Laurenz
60 Min
Product Id: 705031
This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.
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Bullet-Proof CAPA
John E Lincoln
60 Min
Product Id: 700818
In this CAPA training program attendees will learn how compliant CAPA require specific failure investigations, and are dependent upon timely and accurate determination of root cause(s) such as Correction, Corrective Action, Impact Analysis, and Preventive Actions required to meet regulatory expectations.
Surviving an FDA Sponsor Inspection - Training for Success
Stephen Schwartz
105 Min
Product Id: 704516
This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
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Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry
Robert J Russell
90 Min
Product Id: 702038
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
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Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
Charity Ogunsanya
90 Min
Product Id: 703885
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
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Analytical Method Validation Under Good Laboratory Practices (GLPs)
John Fetzer
60 Min
Product Id: 703561
This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.
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Understanding the FDA Compounding Pharmacies Guidance
Carl Patterson
60 Min
Product Id: 705348
This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.
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Understanding and Implementing a Quality by Design (QbD) Program
Steven Laurenz
60 Min
Product Id: 705001
This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.
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Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
Robert J Russell
90 Min
Product Id: 705370
This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.
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4-Hr Virtual Training: How to Respond to an FDA Investigation
Joy McElroy
4 hrs
Product Id: 704549
This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.
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Automating Assays for Clinical Diagnostics
Todd Graham
60 Min
Product Id: 703268
This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.
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You have a BI Positive or Product Sterility Positive - Now What?
Gerry O Dell
60 Min
Product Id: 703288
This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause and the follow up to the investigation.
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Where FDA Is Heading in Regulating Laboratory-Developed Tests
Dennis Weissman
60 Min
Product Id: 705335
The webinar will cover the federal regulatory approach to regulating laboratory-developed tests including the role of CLIA, the rationale for and opposition to direct FDA oversight, the goal of possible federal legislation and the prospects for future action by the FDA and/or Congress.
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Fishbone Diagramming
Michael Abitz
90 Min
Product Id: 705338
This webinar will teach you how to identify potential process problems and avoid process interactions through effective process mapping. It will cover steps to create a fishbone diagram including its purpose, advantages and how to present it.
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SOP's for Bioanalytical Methods Validation
Todd Graham
60 Min
Product Id: 704916
This webinar will help you learn how to validate bioanalytical methods. This session will teach you the pitfalls behind bioanalytical methods validation, allowing one to transition between assays with ease.
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Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971
Tanvir Mahmud
90 Min
Product Id: 702422
This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.
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Estimating Reliability Performance with Accelerated Life Tests
Steven Wachs
75 Min
Product Id: 702095
This webinar on Estimating Reliability Performance of products will show how you can use Accelerated Life Testing methods (ALT) to reduce costs, minimize risks and ensure adequate product performance prior to launch.
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CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE
Sunil Gupta
90 Min
Product Id: 704316
This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.