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What You Need to Do to Prepare for a Successful Inspection


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Who should attend?

Compliance Specialist Clinical Affairs Quality Assurance Management Marketing & Sales

Details

Description:

Senior management takes responsibility for Quality and GXP compliance. It is not something delegated to the Quality unit or to the Regulatory Affairs group. Developing and implementing an effective Inspection readiness plan will help ensure better results, as well as a less stressful inspection. Planning strategically ahead will reduce document turn-around time, improve presentation skills from SMEs, and increase inspector confidence in the Quality System. Successfully completing an FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. 

Why you should attend:

This seminar will offer learning on the following:

How a firm should prepare for an FDA inspection
Ways to train employees in view of the inspection
Field Management Directives
Sub-Systems for Pharmaceutical and Medical Devices
The emphasis on systems-based inspections...and the IOM, QSIT, CPGM and other crucial FDA reference documents
How to ensure that required documentation is in place

Agenda:

Day 1 Schedule

Lecture 1: Introductions and Background

Lecture 2: FDA's Inspectional Authority and History

Lecture 3: FDA Inspection Program Overview

Lecture 4: Key factors for a successful FDA inspection

Lecture 5: Quality System Readiness

Lecture 6: Organization Readiness

Lecture 7: Manage Inspection Outcomes

Lecture 8: Information and Documentation

Lecture 9: How should a firm prepare for an FDA inspection?

Lecture 10: Ways to train employees in view of the inspection

Lecture 11: How to ensure that required documentation is in place

Lecture 12: How to interact with the investigator-DO's and DON'T's

Lecture 13: What companies should do when the inspection ends

Lecture 14: How to reply to 483's and Warning Letters

Lecture 15: Legal implications of non-compliance

Lecture 16: Why inspections are conducted and by what statutory authority

Lecture 17: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents such as QSIT

Lecture 18: What is subject to FDA purview and what's off-limits

Lecture 19: Understand and apply the do's and don'ts and comprehend that preparation is the key to success

Lecture 20: What are the prohibited "Acts" and the enforcement categories that you need to deal with?

Lecture 21: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key

Lecture 22: The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel

Lecture 23: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure

Lecture 24: Define clear responsibilities, roles and goals for personnel involved in FDA inspections and SOP development

Lecture 25: Exit Interview

Lecture 26: FDA interviewing employees and personnel

Lecture 27: Management Controls, Production and Process Controls, Design Controls, CAPA, and sub-systems

Day 2 Schedule

Lecture 1: Quality System, Facilities and Equipment System, Materials System, Production System, Laboratory Controls and Operations, Packaging and Labeling System

Lecture 2: Maintain, or return to, regulatory compliance and minimize downtime

Lecture 3: Establish a risk management plan in place to proactively manage compliance, including a crisis-management plan

Lecture 4: Set post-inspection deadlines and working closely with FDA's regulatory partners

Lecture 5: Compliance remediation is the process of recognizing problems, creating a plan to correct and prevent them from occurring in the future, and executing to that plan to helps with your GxP Compliance Strategy.

Lecture 6: Guidance outlining clear recommendations for sponsors and for FDA staff and managers as well for Pre-Submission meetings as expected timeframes for scheduling meetings

Lecture 7: Mechanics of requesting any FDA meeting and what you need to know to be successful with communication style, approach and tactics

Lecture 8: Prioritize follow-up on warning letters and other enforcement actions

Lecture 9: Develop and implement a formal warning letter "close-out" process

Lecture 10: Untitled Letter and the Warning Letters

Lecture 11: Recent Trends and Enforcement Actions

Lecture 12: Mock Inspections and Mock Audits and why role playing is important

Recap of Day 1 and Day 2

Exercise on Day 2

Interactive Discussions
Review Regulatory and Compliance Documentation
Recent Enforcement Actions and Emerging FDA Trends
Classroom Project: Prepare for and Host an FDA Mock Inspection and Prepare Effective Company Response to FDA 483 and/or Warning Letter

Speaker:

David R. Dills
Global Regulatory Affairs & Compliance Consultant and President, NovaQual 
David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. 


Location:  Washington, DC Date: September 26th & 27th, 2018 and Time: 9:00 AM to 5:00 PM

Venue:  Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Hwy, Arlington, VA 22202, USA

Price:

Price: $1,495.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)*

Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*


Sponsorship Program benefits for seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com


Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901747SEMINAR?seo

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Prices

Price: $1,495.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)* Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*

Contact

Event Manager
john.robinson@globalcompliancepanel.com

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