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Good Documentation Practices (GDPs) for FDA-Regulated Computer Systems
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s C ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jun 19, 2019
HIPAA Security Rule - Explained
This webinar will be addressing how practice/business managers (or compliance officers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the HIPAA Security Rule and any other applicable updates ...
- Basic & Intermediate
- 90 Mins
- Brian Tuttle
- Jun 19, 2019
Food Allergen Programs - Current Trends, Technologies and Risk Mitigation
An Allergen Control Plan is a critical component in your product safety initiatives. Your Allergen Control Plan is your company’s written document regarding the storage, handling, processing, packaging, and identification of allergenic foods and ingredients. ...
- Intermediate
- 60 Mins
- Michael Brodsky
- Jun 19, 2019
How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities
Including a management system into managing Enterprise Risk Areas of Enterprise Risk Management ISO standards family - for what purpose should each standard be used Implementation Tips- costs involved, hiring a consultant, how long does it take, using t ...
- Intermediate
- 60 Mins
- Michael C. Redm
- Jun 19, 2019
Medical Device Complaints & CAPA
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing. Post closing effectiveness evaluation is required and will be explained. Preventative Action is often neglected and will be disc ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Jun 19, 2019
Device Changes and the 510(k) – Hardware and Software
This webinar will evaluate two recently published U.S. FDA Guidance Documents on device changes: 1) “Deciding When to Submit a 510(k) for a Change to an Existing Device Final Guidance for Industry and FDA Staff”; and 2) “Deciding When to Submit a 510(k) for a ...
- Intermediate
- 90 Mins
- John E. Lincoln
- Jun 19, 2019
Unconscious Bias: Injustice In Healthcare!
Implicit, or unconscious bias, exists in society and in the workplace. When it occurs in healthcare, it can be dangerous in compromising the quality of care we give to patients. What does it look like? How can a provider and healthcare organization create an ...
- Basic & Intermediate
- 90 Mins
- Susan Strauss
- Jun 19, 2019
Commerce Control List (CCL) - Policy and Procedures
Your company likely is exporting technical data/technology and software more frequently and in more ways than ever before. The more you export, the more critical it is to make sure you have the accurate classification in the Commerce Control List (CCL). If you ...
- Basic & Intermediate
- 60 Mins
- Rossano Gerald
- Jun 19, 2019
Avoiding Death by CAPA – What you need to know
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. ...
- Basic & Advanced
- 90 Mins
- Susanne Manz
- Jun 20, 2019
Best practices of Drafting and Updating Job Descriptions in 2019: Why You Need Them, What to Include, and What to Leave Out
In this webinar learn how to write effective Job Descriptions and Person Specifications that identify all of the job requirements, and avoid discriminatory language. Writing effective Job Descriptions is one of the most effective ways to clarify expectations a ...
- Intermediate
- 60 Mins
- Stuart Silverma
- Jun 20, 2019