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Past Events

3 Hours Virtual Seminar: Learning Design Controls Through Review of FDA 483 Observations

3 Hours Virtual Seminar: Learning Design Controls Through Review of FDA 483 Observations

10036, NY
DESCRIPTION: Meeting design control requirements is essential to the success of any medical device company. For those that need a primer on where to focus their efforts, the best way to learn about design controls is from the mistakes that other companies have made which resulted in cited FDA 48...
Thursday, October 4 2018 1:00 PM 4:00 PM

Legally Terminating Employees : 10 Complex Issues You Must Know

Legally Terminating Employees : 10 Complex Issues You Must Know

10036, NY
DESCRIPTION Employers must terminate employees from time to time in order to run their businesses effectively. In today’s litigious world, terminating employees is an emotional and legal minefield for managers and supervisors. Even subtle differences in preparing for and conducting terminations ...
Wednesday, September 12 2018 1:00 PM 2:00 PM

Demonstrated Techniques to a Successful 510k Submission

Demonstrated Techniques to a Successful 510k Submission

10036, NY
DESCRIPTION For most medical devices, the road to market includes a gate for 510(k) clearance before the device can be marketed.  Completing the product development process and creating the deliverables necessary for submission can take months if not year.   However, once development is complete...
Thursday, September 6 2018 1:00 PM 2:30 PM

3-Hour Virtual Seminar: Validation Challenges for Bioassays

3-Hour Virtual Seminar: Validation Challenges for Bioassays

10036, NY
Description: Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays have unique requirement...
Friday, August 31 2018 1:00 PM 4:00 PM

Can an Employee be Fired over a Social Media Posting?

Can an Employee be Fired over a Social Media Posting?

10036, NY
DESCRIPTION I posted it on line can I be fired for that comment? Some employees depending in their position may have more rights than others as to what they post on line. Some employees based upon content may have more protection. Does the law distinguish between online vs offline conduct? How i...
Thursday, August 30 2018 1:00 PM 2:00 PM

Creating a Good Design History File for Audit Success

Creating a Good Design History File for Audit Success

10036, NY
DESCRIPTION A Design History File (DHF) is a requirement of QSR 21 CFR Part 820. It is a certainty that in an audit from a regulatory body, information from the DHF will need to be provided. Manufacturer's would be well prepared for audits by regulatory agencies if they know the strengths and we...
Thursday, August 30 2018 1:00 PM 2:30 PM

5-hr Virtual Seminar: Qualification and Control of Suppliers and Contractors for Pharmaceutical and Medical Device Industries

5-hr Virtual Seminar: Qualification and Control of Suppliers and Contractors for Pharmaceutical and Medical Device Industries

10036, NY
Description: This training on qualification and control of suppliers and contractors in the medical devices and pharmaceutical industry will review compliance requirements, the qualification cycle, the key steps involved in it, including the audit process, use of audit tools and evaluation to de...
Thursday, August 30 2018 11:00 AM 4:00 PM

Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do

Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do

10036, NY
Description: This webinar will review not only the Anti-Kickback Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior..   Why Should You Attend: ...
Thursday, August 30 2018 11:00 AM 12:00 PM

3 Hours Virtual Seminar: Developing and Executing A Successful Performance Management Program and Administrating Counseling

3 Hours Virtual Seminar: Developing and Executing A Successful Performance Management Program and Administrating Counseling

10036, NY
Description: Building, developing and utilizing the people in your workforce is the job of every supervisor and the Human Resources and Talent Development professionals in your organization.. In many workplaces supervisors are not comfortable writing and giving performance evaluations and emplo...
Tuesday, August 28 2018 1:00 PM 4:00 PM

Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

10036, NY
Description: This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products..   Why Should You Attend: Current GMP requir...
Tuesday, August 28 2018 1:00 PM 2:30 PM
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