![](/images/products/large/702082.jpg)
Container Closure Systems for Liquid and Lyophilized Products
J. Jeff Schwegman
60 Min
Product Id: 702082
This webinar will discuss various container closure systems that are available for use with liquids and lyophilized products, the components that constitute a container closure system and also cover specialized delivery systems.
![](/images/products/large/700831.jpg)
Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements
John Chapman
60 Min
Product Id: 700831
This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.
![](/images/products/large/704317.jpg)
FDA Regulations and New Legislation for Marketing Cosmetics in the U.S
Norma Skolnik
60 Min
Product Id: 704317
The webinar training will cover FDA regulations for marketing cosmetics and help attendees learn about new proposed legislation which will place new requirements on cosmetic product marketing in the U.S.
![](/images/products/large/703644.jpg)
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer
Gregory Martin
90 Min
Product Id: 703644
This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.
![](/images/products/large/702429.jpg)
Writing Effective and compliant SOPs
Angela Bazigos
90 Min
Product Id: 702429
This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.
![](/images/products/large/704208.jpg)
CDISC Mapping 2: ODM, MindMaps and References
Sunil Gupta
90 Min
Product Id: 704208
This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.
![](/images/products/large/705052.jpg)
Risk Based Monitoring for GCP Compliance
Laura Brown
60 Min
Product Id: 705052
This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
![](/images/products/large/703443.jpg)
Process Challenge Device Development for EO Sterilization
Gerry O Dell
90 Min
Product Id: 703443
This webinar will discuss the role of Process Challenge Devices (PCDs) both during ethylene oxide (EO) validation and during routine processing. It will explain the difference in requirements for PCD during both the processes.
![](/images/products/large/704304.jpg)
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.
![](/images/products/large/704145.jpg)
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.
![](/images/products/large/704803.jpg)
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.
![](/images/products/large/702766.jpg)
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.
![](/images/products/large/701138.jpg)
Failure Modes and Effects Analysis - An effective Risk Management Tool
John Chapman
60 Min
Product Id: 701138
This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
![](/images/products/large/702534.jpg)
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.
![](/images/products/large/704377.jpg)
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.
![](/images/products/large/703739.jpg)
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.
![](/images/products/large/704152.jpg)
CDISC Mapping 1: Specifications and FDA Requirements
Sunil Gupta
90 Min
Product Id: 704152
This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
![](/images/products/large/705358.jpg)
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.
![](/images/products/large/703482.jpg)
Medical Device Employee Training - Requirements and Implementation Tips
Betty Lane
60 Min
Product Id: 703482
This webinar will review types of training requirements from the FDA and ISO 13485 for medical device employee. It will discuss techniques for monitoring and documenting training effectiveness.
![](/images/products/large/702493.jpg)
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.