Boston, MA, September 09, 2015 --(PR.com
)-- Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Each attendee will receive 2 Day workshop materials by the speaker Seminar Also Includes Complimentary Breakfast & High Tea/Coffee provided by WCS.
Seminar One Registration 03-04 Dec Boston Early Bird Valid for Limited attendees $999 Regular Price $1499.
Angela says "But if you prepare, proactively identify and mitigate the compliance risks, you can still achieve good inspection results and avoid or minimize negative impact on your business."
The seminar is designed to provide proactive guidance to quality engineers, regulatory affairs and validation auditors, risk managers, compliance officers and senior management. Angela Bazigos will present best practices and tools to empower participants to simplify management of the following:
-Assess quality system readiness for FDA inspection
-Identify compliance risks
-Mitigate before, during and after the inspection
-Follow up procedures to FDA Form 483, issued to at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
-Responses to warning letters
"The FDA inspection is one of the critical measures for success for your product and your organization as a whole," said Bazigos. "This proven course will provide participants with the knowledge and the tools to build a solid foundation for passing FDA inspections from the perspective of the FDA inspector-valuable information to share with your teams that will benefit your company today and in the future."
If you are looking for the answer to these questions, you will certainly benefit from attending this seminar on preparing for FDA inspections:
• Do you worry about an upcoming FDA inspection?
• Do you know how you should behave during the inspection?
• Do you know what an end to end FDA inspection process looks like?
• Do you know what an FDA investigator(s) will look for?
• Do you know how to proactively assess and mitigate FDA compliance risks?
• Do you know what information you should get ready ahead of an FDA inspection?
• Does your organization have a game plan for managing an FDA inspection?
• Does your organization know how to respond to and manage FDA observations (483s), or warning letters?
Additionally attendees will be provided with:
• 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.
Who will Benefit: This course will provide valuable assistance and guidance to all regulated companies that are preparing for FDA inspections. Meet the below titles
• Quality Engineers
• VPs, Regulatory Affairs
• Risk Managers
• Compliance Officers
• Management Representatives
• Management with Executive Responsibilities
• Members of Senior Management Team
• Validation Managers
WCS experts comes from all corners of the FDA Regulated industries will be onsite to lead presentations, case studies, workshops and panel discussions with Angela Bazigos who is the Chief Compliance Officer of Morf Media. She comes with 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.
Recently, Ms Bazigos was quoted in the Wall Street Journal on Using Training to Bring 4 to the Boardroom.
World Compliance Seminars provides innovative Continuous Professional Education and e-learning solutions and Consulting. Our clients range from SME's to Fortune 500 companies. Our training services set new benchmarks, as a result of which our customers get custom cost-effective, on-demand training solutions from us.