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Events

Seminar

Applied Statistics for Scientists and Engineers 2017

Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation
21 — 22 September 2017
United States, Baltimore, The DoubleTree Baltimore-BWI Airport
Seminar

Project Management for Non-Project Managers 2017

This two-day seminar will begin by laying the foundation for the subject by first defining what a project is and then discussing the unique roles that the project manager must assume along the length of any project
21 — 22 September 2017
United States, Baltimore, The DoubleTree Baltimore-BWI Airport
Seminar

Validation of Computer Systems for Quality and Software Embedded Medical Devices 2017

Understand Verification and Validation, differences and how they work together Develop a "Working Definition" of V&V, Qualification, and related terms
21 — 22 September 2017
United States, Baltimore, Baltimore, MD
Training

Writing and implementing effective SOP 2017

An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory
21 — 22 September 2017
United States, Baltimore, Baltimore, MD
Seminar

Leadership and Team Development for Managerial Success 2017

Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation
28 — 29 September 2017
United States, Boston, Embassy Suites Boston Logan Airport
Seminar

HIPAA Compliance for Small Healthcare Providers 2017

Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also
28 — 29 September 2017
United States, Tempe, Courtyard Tempe Downtown
Seminar

Design of Experiments (DOE) for Process Development and Validation 2017

Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed.
28 — 29 September 2017
United States, Las Vegas, DoubleTree by Hilton Las Vegas Airport
Seminar

What to Expect in a Federal HIPAA Audit & How to Avoid Audit 2017

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).
5 — 6 October 2017
United States, Richmond, Courtyard by Marriott Richmond Downtown
Seminar

FDA's Latest Regulations for Computer Systems Used in the Tobacco 2017

The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016,
5 — 6 October 2017
United States, Richmond, Courtyard by Marriott Richmond Downtown
Training

Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices 2017

Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations
5 — 6 October 2017
United States, Las Vegas, DoubleTree by Hilton Las Vegas Airport