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How to Develop, Implement and Manage an Effective Change Control Program - Webinar (Recorded)

  • Webinar

  • 120 Minutes
  • January 2019
  • Compliance Online
  • ID: 4899544
Why Should You Attend:

The HITECH Act and the 2013 publication of the HIPAA Omnibus Rule, a set of final regulations modifying HIPAA privacy, security, and enforcement rules, have reshaped the privacy landscape and created additional responsibilities for Privacy Officers.

This course will provide a comprehensive overview of the HIPAA Privacy Officers responsibilities and an in-depth road map of best practices. The Privacy Officer training will include all HIPAA required privacy policies and procedures needed for compliance. You will walk away with a thorough understanding on how to administer a successful privacy program.

Areas Covered in the Webinar:

Protected Health Information Breach Risk Assessment and Notification
Community Clergy Access to Patient Listings Under the HIPAA Privacy Standards
Designated Record Set
Determination, Uses and Disclosures of De-Identified Information
Fundraising Under the HIPAA Privacy Standards/HITECH
Hybrid Entity
Privacy Complaint Process
Sanctions for Privacy and Information Security Violations
Uses and Disclosures for which an Authorization or an Opportunity to Agree or Object
Uses and Disclosures of PHI to Other Covered Entities and Health Care Providers Under
Uses and Disclosures of Protected Health Information for Involvement in the Patient's Care and Notification Purposes
Uses and Disclosures Required by Law
Verification of Requestor

Speakers

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.