How to Prepare for and Manage FDA Inspections-OnlineWebinar

Thursday, Apr 27, 2017 at 10:00AM - 1:00PM
Fremont, CA
Item Name Price Each Fee Each Items Left Qty to Buy
Live Session
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$250.00 $8.62 20

Super Combo Offer
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$500.00 $16.34 20

Special Offer
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$625.00 $20.20 20

Corporate Live Session
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$1,250.00 $39.52 10

Event Details

Description
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

Objectives Of The Presentation
  • Types of Inspections
  • Preparation
  • Dedicated personnel for inspection
  • Facility resources to support the inspection
  • Internal audits
  • Mock audits
  • SOP for inspections
  • Behavior during inspection-what to say, what not to say
  • Inspection process
  • 483 response process
Why Should you Attend
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and now you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's your company! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Areas Covered
  • Does the FDA call in advance or just show up at my door?
  • Where do I let the inspector go?
  • Do I give them a tour?
  • What should I let them see?
  • Who should I let them talk to?
  • Are they ever going to leave?
Who will Benefit
  • Quality Auditors
  • Compliance Officers
  • Executive Management
  • Managers/Directors/Supervisors and Personnel related to
  • Regulatory Compliance and Regulatory Affairs
  • Quality Management System
  • Quality Assurance
  • Quality Control
  • Product Development
  • Engineering
  • Manufacturing
  • Risk Management
  • Complaint Handling
  • Personnel new to the regulated industry
  • Training personnel & Document Control Personnel.


For Registration

http://onlinecompliancepanel.com/webinar/RESPONSE-FDA-INSPECTION-508464/APRIL-2017-ES-EZEVENT


Note: Use Promo code DE5YU and get 10% off on registration (Valid till APRIL 30th 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

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Online Event
38780 Tyson Lane, Apt 210
Fremont, CA 94536

Starts April 27, 2017 at 10:00AM - 1:00PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896