2-day In-person Seminar How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection

2-day In-person Seminar How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection is organized by GlobalCompliancePanel and will be held from Sep 26 - 27, 2018 at Courtyard by Marriott Arlington Crystal City/Reagan National Airport, Arlington, Virginia, United States of America. This CME Conference has been approved for a maximum of 12 credits.

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. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome.

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
• Why inspections are conducted and by what statutory authority
• The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
• Define and execute proven GxP Compliance Strategies
• Proven Operational Readiness and State of Readiness tactics
• Determine optimal pathway during inspections and post-inspection correspondence and meetings
• Improve credibility and trust with FDA and other regulators
• Important training areas in GxP compliance and topical issues
• Gain a better understanding of how to interact and communicate effectively with FDA
• Identify the ground rules and do's and don'ts with FDA inspections
• Prepare for lively discussions and a mock inspection as part of a classroom exercise
• Communicate effectively with FDA and reference FDA guidance and other critical resources.

Who will benefit:
• Executive Management
• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Auditors
• QC/QC Management
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Quality Assurance Management
• Marketing & Sales
• Laboratory Operations
• Distributors/Authorized Representatives
• Legal Counsel
• Engineering/Technical Services
• Operations/Manufacturing
• Consultants
• Individuals who come in contact with regulatory inspectors
• Auditors
• Compliance/Regulatory affairs professionals
• QA/QC professionals
• Manufacturing managers, supervisors & personnel
• Project Managers
• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Distributors
• Legal Counsel

Speaker:
David R. Dills
Time: 9:00 AM to 5:00 PM

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%)