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Submitted by: GRC Training Solutions
Description:
This seminar is intended to discuss what FDA-regulated industry should know about FDAs inspection policy to better implement the best Good Manufacturing Practices (GMPs). The common deficiencies found based on 483s issued to medical device and pharmaceutical industries will be discussed. The most common deficiencies are based on the speakers analysis of 483s issued for the past eight (8) years.
This presentation will greatly help you better prepare for and manage an FDA inspection in a proactive and effective manner.
The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Donts before, during and after the inspection.
This presentation will provide great opportunities to become familiar with the FDA inspection policy and industrys best GMP practices including the lessons learned from the most common deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.
Areas To Be Covered in this Seminar:
Applicable Laws and Regulations
FDA Manuals and Inspection Guides
Hosting an FDA Inspection
Inspection Types and Categories
Inspection Classification
FDA Forms 482 and 483
Common deficiencies in 483s
What/How to Prepare for and Manage an FDA Inspection
How to Communicate Before, During and After inspection: Dos and Donts
Inspection Preparation Procedures
Close Out Meeting
Responding to 483s, If Issued
How to Communicate with Emotional Intelligence
Employee Training
Actual Case Studies
Speakers PASS-IT Recommendations
Who will benefit:
CEOs
VPs
Compliance Officers
Attorneys
Regulatory Affairs
Clinical Affairs
Quality Assurance
R&D
Consultants
Contractors/Subcontractors
Anyone Interested in the FDA Drug Review and Approval Processes
Instructor Profile:
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, 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 eight 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.
GRC Training Solutions is a premier training and solutions company that conducts high impact training’s in Corporate Governance, Regulatory Compliance, Quality Management and Risk Management.
GRC training modules are designed and facilitated by industry experts who possess a strong theoretical and working knowledge of the required regulatory compliance requirements. GRC Training Solutions uses Government and industry best practices and relevant software tools to help companies of all sizes accelerate business performance by helping them understand how to effectively operate within the various guidelines and regulatory frameworks.The training modules are designed for senior and mid level management and executives.
GRC Training Solutions offer companies tailor made solutions that suit different professional needs and are available in different mediums live training sessions at conferences or in-house classroom training, consultation, webinars, seminars and podcasts. Whichever training module the organization opts for- classroom training or webinar each attendee will gain a thorough understanding of the key concepts of Corporate Governance. Even after professionals successfully complete the training sessions, GRC Training Solutions experts are available to answer queries and provide whatever assistance is required.
What makes GRC Training Solutions unique is a proven track record, use of latest technology, updated and engaging training modules and competitive pricing.
Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.Inspection Preparation Procedures
About the Author: GRC Training Solutions is a premier training and solutions company that conducts high impact training’s in Corporate Governance, Regulatory Compliance, Quality Management and Risk Management.GRC training modules are designed and facilitated by industry experts who possess a strong theoretical and working knowledge of the required regulatory compliance requirements. GRC Training Solutions uses Government and industry best practices and relevant software tools to help companies of all sizes accelerate business performance by helping them understand how to effectively operate within the various guidelines and regulatory frameworks.The training modules are designed for senior and mid level management and executives.GRC Training Solutions offer companies tailor made solutions that suit different professional needs and are available in different mediums live training sessions at conferences or in-house classroom training, consultation, webinars, seminars and podcasts. Whichever training module the organization opts for- classroom training or webinar each attendee will gain a thorough understanding of the key concepts of Corporate Governance. Even after professionals successfully complete the training sessions, GRC Training Solutions experts are available to answer queries and provide whatever assistance is required.What makes GRC Training Solutions unique is a proven track record, use of latest technology, updated and engaging training modules and competitive pricing.For More Details:Email: support@grcts.comTel: +1-248-233-2049Web:
grcts.com
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