Webinar On Good Practices in Preparing for an FDA Inspection Preparation with Awareness: Do's and Don'ts

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Good Practices in Preparing for an FDA Inspection
Preparation with Awareness Do's and Don'ts
Product Id
FDB1350
Category
Food, Drugs Biologics
Scheduled On
Monday, June 16, 2014 at 1300 Hrs
Duration
60 Minutes
Speaker
Dr. David Lim
To register for this webinar https//compliancetra
inings.com/siteengine/Login.aspx
Webinar Description

This webinar is intended to help you get
familiar with how to prepare for and manage an
FDA inspection in an actionable, sustainable
manner with improved awareness. If a firm is
subject to FDA regulations, they should be ready
for an FDA inspection. This webinar provides
PASS-IT strategy and strategic plan/planning on
your FDA inspection preparation integrated with
emotional intelligence (EQ) skills. It is
delivered in a way to help you effectively
communicate and improve awareness and
preparedness for an FDA inspection at all levels
of organizations. This webinar will discuss what
you need to be aware and familiar with to get
ready for an FDA inspection with confidence. In
particular, a list of Dos and Donts will be
shared and explained for your maximum
advantages.
Areas Covered in the Session

• Applicable Statutes and Regulations
• Definitions
• FDA Manuals
• FDA Inspection Scope and Depth
• Inspection Types and Categories
• Inspection Classification
• Inspection Process
• Hosting an FDA Inspection
• Act with Awareness and Familiarity
• Common Questions and Responding to Questions
• FDA Forms 482 and 483
• Responding to 483  How to Avoid Mistakes
• Before, During and After FDA Inspection Dos and
  Donts

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Who Will Benefit

• CEOs
• VPs
• Compliance Officers
• Attorneys
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• Research Development Teams
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the FDA inspection Process

Speaker Profile
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is
President and Principal of Regulatory Doctor
(www.RegulatoryDoctor.com). Dr. Lim frequently
presents global regulatory and quality compliance
topics in various forums and meetings. Recently,
Dr. Lim developed 510(k) templates ready for use
compliant with e-Copy and RTA policy. In
addition, Dr. Lim developed FDA inspection
checklists for drug and medical device
manufacturers based on his analysis of FDA
inspectional observations cited in 483s for the
past seven years. Dr. Lim provides his feedback
to regulatory agency (e.g., US FDA) through
public comments and also served as a panel member
during the FDAs transparency public meeting in
2009. Dr. Lim contributes to the Regulatory
Affairs Professional Society (RAPS) as an author.
Dr. Lim leads and directs all research projects
including pharmacovigilance, medical device
reporting, recalls and patient safety signals
being conducted at the Regulatory Doctor.

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