New Finalized HITECH Amendments to HIPAA - How Policies and Practices Must Be Changed
Jim Sheldon-Dean
90 Min
Product Id: 702457
This 90-minute webinar will help you review your HIPAA compliance policies, and procedures to see if you are prepared to meet the changes in the HIPAA privacy and security regulations that were finalized by the end of Summer, 2012 and went into effect just 60 days later.
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.
Third Party Information Security Assessment
Alexandro Fernandez
60 Min
Product Id: 702674
This webinar on information security assessment will highlight the principal steps/ methodology for performing a third party information security assessment.
3-hr Virtual Seminar: Overview of New Risk Oversight Expectations and Reporting Rules
Tim J. Leech
3.5 hrs
Product Id: 702705
This 3-hr virtual seminar will present an overview of new risk oversight expectations and reporting rules in place, and show how companies, risk managers and internal auditors can meet these regulatory expectations.
How to Create Repair Station Manuals in Compliance with Title 14 Code of Federal Regulations (CFR) Part 145
Greg Fredenburg
60 Min
Product Id: 702468
This webinar will show how to easily interpret the FAA guidance material to create the manuals - Repair Station Manual (RSM), Quality Control Manual (QCM), and Training Program Manual (TPM) - that form the basis for the approval of new repair station certificates and continuing compliance for current repair station certificate holders.
Microbiological Sampling of Foods
Jim Dickson
60 Min
Product Id: 702659
This webinar on microbiological sampling for foods will address fundamental approaches to sampling, from raw materials to finished products. Topics will include sampling plans, sample collection methods and chain of custody issues. A primary focus will be on interpretation of results, based on the limitations of sampling plans and microbiological methods.
Bad Debt Forecasting: Two Methods to Accurately Calculate Future Trade Credit Losses
Pam Krank
90 Min
Product Id: 702573
This webinar highlights the evolution in methodologies for forecasting trade credit bad debts. Many companies have relied on historical data or a flat percentage of sales to help forecast future credit losses. However, these methodologies don’t allow for changing markets, customer growth, or even increasing geographical diversity. A more accurate measure of future bad debt would examine your existing customer risk and determine what these risk elements tell you about the future possibility of credit losses.
Implementing Risk-based Verification for Pharmaceutical Manufacturing Companies
Daniel Franklin
90 Min
Product Id: 702598
This webinar will help you understand the industry background to the current transition to Risk-based Verification processes and the current trend in implementation by industry. You will learn the regulatory foundations, industry guidance, and primary components of risk-based verification as it relates to an overall specification, design, and verification program as outlined in ASTM E-2500-07; “Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment;” ASTM, 2007. Key implementation considerations and initial steps will be discussed.
Fall Protection - Federal OSHA Requirements
Edward R Bulakites
80 Min
Product Id: 702628
This webinar will help you to understand OSHA’s fall protection requirements and which ones apply to you. It will also guide you in selecting the best option, for the work being done, from among the various approaches to fall protection.
Make your Electronic Health Records HIPAA Compliant
Paul R Hales
60 Min
Product Id: 702603
This training will cover HIPAA compliance requirements for Electronic Health Records (EHR) including Stage 1 and Stage 2 Meaningful Use Attestation.
Optimal Clinical Supply Planning for Global Drug Development
Vladimir Shnaydman
60 Min
Product Id: 702552
This webinar will discuss how to manage supply chain risk to optimize clinical trial supply and also manage demand side requirements, risk of stock out, cost management etc using novel tools and technologies.
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.
3-hr Virtual Seminar: Why and How to Go Global - 5 Foreign Market Entry Techniques
Douglas Cohen
3 hrs
Product Id: 702643
This training on foreign market entry techniques will cover the process and procedures in entering new global markets, while avoiding export fines, violations and denial of export privileges by being compliant.
Fraud in Social Media and How to Protect Yourself and Your Organization
Peter Goldmann
60 Min
Product Id: 702606
This fraud in social media webinar will discuss various types of frauds that can happen in social media and how to protect your and your organization’s interests from it. Policies or essential information need to be in place to reduce risk of fraud victimization via social media.
Gluten-Free Labeling Under the Current Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 and Beyond
Katherine Giannamore
60 Min
Product Id: 702597
This webinar on gluten-free labeling will detail the efforts made by the USFDA pursuant to the obligations mandated by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). It will show how foods manufacturers and labelers may use the term “gluten-free” in product labeling and what this distinction means. This webinar will highlight the Agency’s action with respect to developing gluten-free regulations and the current status of these requirements.
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.
Healthcare Data Breach - Have you secured your patient data?
Alan Roth
60 Min
Product Id: 702680
This webinar on securing ePHI data will discuss best practices in healthcare data security, compliance, and legal issues regarding patient data. It will help you mitigate the risks of a breach and show what needs to be done in the event of a security incident.
Regulatory Readiness in 2013 - Comprehensive Compliance Training Package for Pharma Companies (8 Courses)
James Russell ,Robert J Russell,T.C Soli,Gregory Martin,Mukesh Kumar,Sandra N. Whetstone,Karl M. Nobert
15 hrs
Product Id: 702721
This comprehensive training package of 8 courses is aimed at helping pharma/drug companies avoid the most cited regulatory pitfalls and ensure their compliance initiatives for 2013 are on the right track.
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.
Compliant Supply Chain & Manufacturing for Medical Devices - Comprehensive Training Package (8 Courses)
Rob Braido,Gerry O Dell,Betty Lane,Jeff Kasoff,John E Lincoln
10 hrs
Product Id: 702706
This comprehensive training package of 8 courses is aimed at helping medical device companies ensure that their supply chain controls and manufacturing processes comply with existing regulations.