Compliance News Web-based Seminars

HIPAA and Electronic Health Records Meeting the new requirements and new regulations - Webinar By GlobalCompliancePanel The new and proposed HIPAA Privacy and Security regulations will be reviewed and their effects on the use of EHRs will be discussed. The proposed rules call for an ability to make an electronic copy of an individual's protected health information for any information held in an entity's designated record set.  more...

The Controls for Outsourcing Manufacturing and Testing - Webinar By GlobalCompliancePanel The Controls for Outsourcing Manufacturing and Testing" explores the use of outsourcing and how it impacts quality and compliance and the organization as a whole. The primary stakeholders and outsourcing include Quality, Research, Production, Laboratories, Purchasing/ Procurement, Finance, and Senior Management. This webinar will study the outsourcing lifecycle and its impact on the  more...

Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost GlobalCompliancePanel brings a new webinar on the topic of Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost. Webinar will be on April 6, 2010. Webinar will be presented by David Nettleton. This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software  more...

Specification Development GlobalCompliancePanel brings a new webinar on the topic of Specification Development. Webinar will be on March 23, 2010. Webinar will be presented by Melinda Allen. A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract. Specifications are a customers greatest tool for ensuring products received  more...

Design Planning and conducting Effective audits GlobalCompliancePanel brings a new webinar on the topic of Design, Planning and conducting Effective audits. Webinar will be on March 23, 2010. Webinar will be presented by Mark Roberts. Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and  more...

21 CFR Part 11 Auditing for Part 11 Compliance GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 18, 2010. Webinar will be presented by Jasmin NUHIC. 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.  more...

Update on Unique Device Identifier for Device Manufacturers FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely  more...

PCI Data Breaches What happened What may have prevented it What if it happens to you If your organization is struggling to meet compliance requirements for PCI, you're in good company. Unfortunately, in this case there is no safety in numbers. Criminals do not necessarily attack big companies; they go after whatever is easy. The cost of responding to a breach is getting more expensive each year. In this webinar you will learn about the current threat environment, how some of  more...

New Requirements for the Medical Device Directive MDD GlobalCompliancePanel brings a new webinar on the topic of New Requirements for the Medical Device Directive (MDD) Webinar will be on March 11, 2010. Webinar will be presented by Albert Cefalo. Mr. Cefalo has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career  more...

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems GlobalCompliancePanel brings a new webinar on the topic of Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems. Webinar will be on March 11, 2010. Webinar will be presented by Teri C. Soli. Mr. Soli has 25 years of diverse "Big Pharma" operating company experience. During his 30 year career he has lectured extensively at conferences, authored numerous papers and  more...

Excel Spreadsheet Validation To Eliminate 483s GlobalCompliancePanel brings a new webinar on the topic of Excel Spreadsheet Validation To Eliminate 483s. Webinar will be on March 10, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development,  more...

Foreign Material Control GlobalCompliancePanel brings a new webinar on the topic of Foreign Material Control. Webinar will be on March 9, 2010. Webinar will be presented by Melinda Allen. Ms. Allen is a Food Safety and Quality Consultant in the Food Industry. Melinda has had a long and dedicated career of Quality Assurance and Food Safety leadership with companies such as YUM Brands and Quiznos.  more...

Validating Radiation Sterilization for medical device industries GlobalCompliancePanel brings a new webinar on the topic of Validating Radiation Sterilization for medical device industries. Webinar will be on March 9, 2010. Webinar will be presented by Mark Roberts. Mr. Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the  more...

The 510k Submission Requirements Contents and Option GlobalCompliancePanel brings a new webinar on the topic of The 510(k) Submission: Requirements, Contents, and Option. Webinar will be on March 4, 2010. Webinar will be presented by Jeff Kasoff. Mr. Kasoff is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for  more...

Business, Project and Compliance Risk GlobalCompliancePanel brings a new webinar on the topic of Business, Project and Compliance Risk. Webinar will be on March 2, 2010. Webinar will be presented by Edwin L Bills. Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement.  more...