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Webinar On FDA Inspection Readiness
Pam Dellea Giltner
90 Min
Product Id: 705974
This FDA inspection webinar will show you what it means to be “Inspection Ready” and how a Quality System in place at your company will ensure ongoing quality measures to be ready at any time for an audit, review by a Sponsor or any regulatory agency inspection.
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Technical Writing for Medical Products: SOPs, Investigations and Change Records
Regina Fullin
60 Min
Product Id: 704304
In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
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FDA Regulations for Marketing OTC Drugs and New Legislation
Norma Skolnik
60 Min
Product Id: 704145
This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.
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Risk Analysis in Medical Device Design
Charles H Paul
60 Min
Product Id: 704803
This webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective risk and hazard analysis for medical devices as per FDA, FTA, FMEA, and FMECA guidelines.
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The Most Serious FDA 483s - How to Avoid Them
John E Lincoln
90 Min
Product Id: 702766
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
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How to Write Effective 483 and Warning Letter Responses
Kelly Thomas
90 Min
Product Id: 705918
In this regulatory inspection webinar attendees will learn the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response. Also attendees will learn the proper structure of the response to ensure the regulatory agency’s expectations are met and the submission process is properly understood.
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Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory
Gregory Martin
90 Min
Product Id: 702534
This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
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FDA Regulations for Environmental Monitoring (EM) Program
Joy McElroy
90 Min
Product Id: 704377
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
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Current Concepts and Challenges in Cloud Compliance
Angela Bazigos
90 Min
Product Id: 703739
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
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FDA Compliance and Clinical Trial Computer System Validation
Carolyn Troiano
60 Min
Product Id: 705358
This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.
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Project Management for Computer Systems Validation
Angela Bazigos
90 Min
Product Id: 702493
This computer system validation training will highlight the principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show how you can use project management tenets to deliver on time and on budget, while meeting FDA regulatory compliance requirements.
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Pharmacokinetics/Biopharmaceutics for Chemists/Analysts
Saeed Qureshi
120 Min
Product Id: 705271
This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Dr. Ludwig Huber
75 Min
Product Id: 701242
This excel validation training / webinar will demonstrate how to design spreadsheets for Part 11/GxP /SOX/HIPAA compliance. And how to document planning, specifications, installation, testing and changes to meet FDA requirements.
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Winning Strategies for Successful US FDA Inspections: Conducting an Effective Mock Pre-Approval Inspection & Implementing Robust Remedial Measures
Nada Kuganathan
90 Min
Product Id: 705925
In this Webinar, attendees will learn the winning strategies for successful FDA inspections and as how to conduct robust mock audits during pre-submission and post submission stages of drug product applications. This webinar will also include strategic approaches to implement robust remedial measures to mitigate the potential quality and compliance risks identified during the mock pre-approval inspection in a proactive manner.
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Complaint Handling, MDR's & Recalls
John Chapman
60 Min
Product Id: 700830
This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.
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Achieving Success and Compliance in the Supply Chain
Danielle DeLucy
60 Min
Product Id: 705907
This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.
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ASTM 2500: Lessons Learned Through a Decade of Implementation
Kelly Thomas
90 Min
Product Id: 705911
This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach.
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Effective Training Practices for FDA Compliance
Dr. Ludwig Huber
75 Min
Product Id: 701243
This FDA compliance webinar will help the attendees develop an effective training program and training plans for an organization. Attendees will learn GxP training requirements in US and EU.
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Data Governance for Computer Systems Regulated by FDA
Carolyn Troiano
60 Min
Product Id: 704745
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
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Cell Based Assays: Development and Validation
Michael Simonian
60 Min
Product Id: 704528
This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.