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FDA and Social Media - How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws and Regulations
Mark Gardner
90 Min
Product Id: 702907
This webinar on FDA social media regulations will discuss the best practices utilized by medical device, drug and other FDA and FTC regulated industries when using social media channels, i.e., Web 2.0, like Facebook, Twitter, YouTube and LinkedIn to promote products.
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Global Medical Device Laws and Regulations: US, EU, and Canada
David Lim
90 Min
Product Id: 702842
This training on global medical device regulations will discuss the regulatory framework for medical devices in US, EU and Canada. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these countries.
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FDA's Revised 510(k) Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions and Regulatory Compliance
Chris Cook
70 Min
Product Id: 702963
This medical device 510(k) training will help you understand the basics of 510(k) submissions and discuss how to develop and execute an approval strategy ensuring the fastest possible path to market.
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Medical Device Reporting for Manufacturers, Importers and Medical Device User Facilities
Kosta Makrodimitris
90 Min
Product Id: 702958
This webinar on Medical Device Reporting (MDR) will cover FDA requirements for importers, manufacturers and hospitals to report medical device adverse events. It will discuss current policies and guidances for Medical Device Reporting and provide update on upcoming regulations.
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The Sunshine Act Final Rule
Mark Gardner
120 Min
Product Id: 702825
This session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.
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Asian Medical Device Laws and Regulations: China, Hong Kong, Japan and Korea
David Lim
90 Min
Product Id: 702841
This training on Asian medical device regulations will discuss the regulatory framework for medical devices in China, Hong Kong, Japan and Korea. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these Asian countries.
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How to Make GMP Training Fun and Engaging
Grimoalda Botelho
60 Min
Product Id: 702808
This session on conducting effective GMP trainings will cover proven learning techniques for technical and compliance related trainings. It will answer key questions about how to make GMP training sessions more engaging and even fun for the learners in your organization.
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3-hr Virtual Seminar - The Interface Between Medicare and Medicaid, Anti-kickback Statute (AKS), Stark II and the Federal Civil False Claims Act (FCA): Is your Organization at Risk?
William Mack Copeland
3 hrs
Product Id: 702787
This healthcare compliance training will explain how the FCA, the AKS and the Federal Physician Self Referral Law (Stark II) work, the prohibitions, exceptions and safe harbors. It will review recent examples to show how they interface and can potentially impact you/ your organization.
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FDA Warning Letters - Stop Fumbling your Response and Effectively Demonstrate Compliance
Marc Sanchez
60 Min
Product Id: 702797
This training will outline the best practices in responding to a FDA Warning Letter so the consequences of the findings do not escalate beyond the current status.
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ISO 13485 - Medical Devices: Quality Management Systems
Peter Spath
90 Min
Product Id: 702743
This ISO 13485 requirements training will provide guidance to medical device companies in developing an adequate Quality Management System (QMS) in accordance with ISO 13485 and FDA expectations. This webinar will also benefit medical device companies that are planning to market their products in Europe.
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The Caronia Court Decision and Off-Label Promotion: What Does this Mean for FDA's Regulation of Pharmaceutical and Medical Device Off-Label Marketing and Promotion?
Karl M. Nobert
90 Min
Product Id: 702739
This webinar will provide an introduction to FDA’s regulation of product labeling and promotion; and the Agency’s position with regards to off-label promotion and how the Court’s decision in the Caronia case might affect the off-label promotion of Rx drug products and medical devices.
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Social Media: Using The Legal Guideposts to Create Social Media Success (for Healthcare/Lifescience Companies)
Kenneth N Rashbaum
60 Min
Product Id: 702596
This social media compliance training for healthcare companies will cover the legal and regulatory requirements governing the use of social media. A scenario-based learning approach will be used to show how to create a successful social media team by selecting members from relevant stakeholders, and prepare social medial policies and procedures.
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Process Validation for Medical Devices - The Regulatory Approach
Dan OLeary
90 Min
Product Id: 702673
This medical device process validation training will use recent warning letters to explain the regulatory requirements for process validation and what FDA Investigators look for. It will cover process validation components (IQ, OQ, and PQ), and the content of protocols and reports.
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510(k) Submissions: Your Path to the US Medical Device Market
Chris Cook
75 Min
Product Id: 702704
This medical device 510(k) training will explain the basics of 510(k) submissions and discuss tips, strategies and tools to develop and execute an approval strategy ensuring the fastest possible path to market.
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Using Electronic and Digital Signatures in Regulated Environments
Dr. Ludwig Huber
75 Min
Product Id: 702672
This webinar will familiarize you with FDA requirements for electronic and digital signatures, and the agency's inspection and enforcement practices. Particpants will recieve complimentary hand-outs for easy implementation.
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Essentials of Sterilizing Grade Filter Validation
Maik Jornitz
75 Min
Product Id: 701654
This webinar on sterilizing grade filter validation will describe the essential requirements and steps for process validation of sterilizing grade filters. It will discuss multiple guidance documents in regard to sterilizing grade filtration and their interpretation.
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Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries
Shahbaz Shahbazi,Ray Bandziulis
75 Min
Product Id: 702614
This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.
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Modifications to a Cleared Device - FDA's 510(k) Guidance
Daniel O Leary
90 Min
Product Id: 702595
This 90-minute webinar will explain FDA's 1997 guidance on 510(K) for device modifications and show how to integrate the evaluation into your design change program. The webinar uses numerous Warning Letters to illustrate the points, and helps you learn from others.
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Personnel Practices and Microbial Control in Pharmaceutical, Biotech, and Medical Device Manufacturing
Jim Polarine
90 Min
Product Id: 702446
This 90-minute webinar on personnel practices and microbial control in Pharmaceutical, Biotech, and Medical Device manufacturing will cover effective ways to train personnel on gowning and personnel practices in cleanroom operations to limit contamination. This webinar will also address controlling microorganisms on process equipment and product contact surfaces.
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Proposed Changes in the European Medical Device Directive 2012\0266 (COD): A Practical Approach to the New Regulations
Robert Packard
60 Min
Product Id: 702555
This EU MDD webinar will help you understand and recognize the most significant changes proposed for the new European Medical Device Regulations: 2012/0266 (COD). You will learn which procedural changes your company should be making now so that you stay in compliance throughout the transition period and reduce potential delays to new product introductions in the EU market.