Boston, MA -- (SBWIRE) -- 10/22/2015 -- World Compliance Seminars announces for 2 Day Seminar How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach at Hilton Garden Inn Boston Logan Airport

Location 1 - Dec 3 to Dec 4 2015 at Boston MA ( Hilton Garden Inn Boston Logan Airport )

Location 2 - Feb 4 to Feb 5 2016 at San Diego CA Hilton

Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion

Attend this highly-interactive workshop that will teach you how know how to respond to and manage FDA observations (483s), or warning letters.

Early Bird Registration at $699 valid for only few attendees .Regular Price $1299 for 2 Day Pass

(Includes 12 RAC Recertification credits, 2 day workshop materials ,Certficate & Breakfast)

This two-day workshop will be led by Angela Bazigos, is the Chief Compliance Officer of Morf Media. She has 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices and 21 CFR 11 and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She has been on the board for UC Berkeley's Business School for Executive Education in Life Sciences and is now on the Stanford Who's Who Registry for contributions to the Lifesciences industry

What You Will Learn
Not only does this workshop provide you an opportunity to hear from an acknowledged expert in FDA Inspection, but you'll also share experiences and learn from your fellow attendees who are confronting the same issues as you.
Attend this critical workshop and you'll find out:

- Background about FDA inspection program.
- How to proactively assess quality system readiness for FDA inspection.
- How to identify compliance risks. - How to proactively mitigate before, during and after the inspection.
- How to respond to 483s and warning letters including templates based on industry best practices.

Course Objectives:
- To provide an overview of the FDA inspection program and key success factors for a manufacturer.
- To introduce the best practices on how to manage inspections including a template of game plan.
- To introduce the industry best practices on what information should be prepared ahead of inspection including a checklist.
- To introduce the best practices including templates on how to respond to and closeout FDA 483s and warning letters.
- To introduce the best practices and toolkit on how to assess readiness for a FDA inspection, and how to proactively identify and mitigate compliance risks.

This seminar will help you save your firm's significant efforts and resources, potentially saving millions of dollars by learning actionable approaches with improved awareness and familiarity.

Who Should Attend
This course will provide valuable assistance and guidance to all regulated companies that are preparing for FDA inspections. The following job titles/ positions will benefit from attending this seminar:
- Quality Engineers
- Managers - Directors
- VPs, Regulatory Affairs
- Auditors - Risk Managers
- Compliance Officers
- Management Representatives
- Management with Executive Responsibilities
- Members of Senior Management Team
- Validation Managers

But that's not all. There's one other way you'll benefit in a big way from attending WCS FDA Inspection Seminar .

There's no doubt what a challenge it is to know the correct way that work for your staff and are also compliant with FDA regulations.

That's why, in the workshop materials, we've provided the following essential "exclusive materials:"

12 credits towards a participant's RAC recertification upon full completion

A set of detailed handouts
Toolkit on how to assess a quality system's readiness, and identify and mitigate potential compliance risks.

A checklist of information that should be prepared prior to inspection.

A strategy template on how to manage a FDA inspection (front room, back room, role playing, dos and don'ts, etc.). Toolkit on how to prepare responses to 483 observations and warning letters.

Certificate Signed By the Top FDA Speaker

And more….

They'll help you prepare you streamline your FDA Inspection and with confidence.

This two-day workshop is a rare opportunity to learn from an acknowledged expert … to rub elbows with colleagues who daily encounter the same issues that you do … to pick their brains … absorb their knowledge … and develop contacts who'll be invaluable to you all through the year.

Email us support@worldcomplianceseminars.com or Call Us 844-267-7299 , 347-282-5400

https://worldcomplianceseminars.com/seminardetails/5