We invite you join us at 2 Day Seminar How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach taking place at Boston,MA on Dec 03-04 ,2015 or Feb 4-5 San Diego CA

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

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

World Compliance Seminars has designed this event to provide intensive, two-day training in Supplier Management for Medical Device Manufacturers at Hilton Garden Inn Boston Logan Airport on Dec 3 to Dec 4, 2015 at $799 only

Boston, MA -- (SBWIRE) -- 10/22/2015 -- We invite you join us at 2 Day Seminar Supplier Management for Medical Device Manufacturers place at Boston,MA on Dec 03-04 ,2015.

Attend this highly-interactive workshop that will teach you how know the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation for supplier management.

REGISTER AND HEAR BY TOP SPEAKER

This two-day workshop will be led by Betty Lane who has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, while having a cost-effective Quality Management System. Her background in digital systems engineering enables her to facilitate implementation of design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation. Betty's training experience includes over 25 years of training on all aspects of FDA Quality System Regulation (cGMP) and ISO 13485, the ISO standard for Medical Device - Quality Management Systems for ASQ, AAMI, and colleges.

Early Bird Registration at $999 valid for only few attendees. Regular Price $1299 for 2 Day Pass
(Includes 12 RAC Recertification credits, 2 day workshop materials, Certficate & Breakfast)

What You Will Learn

Not only does this workshop provide you an opportunity to hear from an acknowledged expert in the subject , 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:

How to prepare yourself and your contract manufacturer for unannounced manufacturing audit
Understand FDA QSR and ISO 13485 requirements for supplier management
Creating a Risk-based Multi-tier supplier classification system
Understand when suppliers have to register and list with the FDA
Explain the link between design control and purchasing data
Develop a risk-based supplier management process
Incorporating supplier regulatory and safety risk
Incorporating supplier business risk
Defining and using supplier Metrics for measuring and monitoring of suppliers
Supplier audits, what is required and what is good practice

One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers.

This seminar will not only review requirements and expectation of the FDA and European Notified Bodies for supplier management, but will guide you on how to incorporate these into your supplier management process.

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. The following job titles/ positions will benefit from attending this seminar:

Quality Managers
Quality Engineers
Supplier Managers
Supplier Engineers
Internal quality auditors
Supplier auditors

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

Two guidance documents referenced

GHTF Guidance document: Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

NBOG Guidance document: Guidance for Notified Bodies auditing suppliers to medical device manufacturers

Example Approved Supplier list

Example Supplier evaluation form

2 examples of Supplier QA Agreements

And more….

Building partnerships with your suppliers not only helps you meet FDA and ISO 13485 Notified Body requirements, but can add value to your quality management system and your company as well.

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.

Don't wait. Register TODAY or email us support@worldcompliancesemiars.com

Special Group discounts available call us on Toll Free 844-267-7299 to avail the same.

https://worldcomplianceseminars.com/seminardetails/6

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

World Compliance Seminars has designed this event to provide intensive, two-day training in HIPAA compliance, including what’s new in the regulations, what’s changed recently, and what needs to be addressed for compliance on Oct 22-23 , 2015.

Chicago, IL -- (SBWIRE) -- 09/25/2015 -- World Compliance Seminars announces for 2 Day HIPAA Seminar at Doubletree Chicago, Illinois Thursday, Oct 22 to Friday Oct 23, 2015. Attend this highly-interactive workshop and learn how to discover risk issues through the review of breaches, audits, and enforcement actions.

This two-day workshop will be led by Jim Sheldon-Dean Principal and Director of Compliance Services, Lewis Creek Systems, LLC. He has been providing information privacy and security regulatory compliance services to a wide variety of health care entities. Mr. Sheldon-Dean serves on the HIMSS Information Systems Security Workgroup, has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup, and is a recipient of the WEDI 2011 Award of Merit.

This Seminar will provide valuable assistance to personnel in Medical offices, practice groups, hospitals, pharmacies, academic medical centers, medical devices, insurers, healthcare business associates (shredding, data storage, systems vendors, billing services, lawyers, etc.)

Not only does this workshop provide you an opportunity to hear from an acknowledged expert in HIPAA compliance, 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:
- What has to be modified to meet the updated rules and how to interpret them
- Understand the structure of the HIPAA Regulations and how they work together
- Learn how Business Associates are now covered directly under the rules
- Understand what are the rights individuals have about their health information
- Learn about how to provide access to information properly
- Know what are the limitations on uses and disclosures by a healthcare entity

The cost for 2 Day Event is $999 . Attendees who complete the training will be awarded with Certificate of professional development with continuing education credits. Above reduced cost will be valid till 15th Oct.

Fore More Information you can contact us on PH 347-282-5400 or Toll Free 844-267-7299

https://worldcomplianceseminars.com/seminardetails/4

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm