Why is FDA at my Facility & What do I do During an Inspection at Singapore

Overview:
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favourable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

Who Will Benefit:
Industries:
• FDA regulated Industries
o Medical Device
o Pharmaceuticals
o Clinical
• Dietary Supplements
o Food
o Nutraceutical
• Healthcare IT
o Technical Services
o Validation
o Engineering

Departments
• Top and Middle Management
• Quality Assurance/Management
• Compliance Management
• Manufacturing
• Laboratory
• Regulatory Affairs
• Information Technology
• Marketing & Sales
• Operations
• Research & Development

Types of facilities:
• Manufacturing facilities
• Contract manufacturing facilities
• Distributors
• Packaging, Labeling
• API Suppliers
• Laboratories
• Importers
• Documentation Management

Agenda:

Day One
Lecture 1: How a firm should prepare for an FDA inspection
Lecture 2: Ways to train employees in view of the inspection
Lecture 3: How to ensure that required documentation is in place
Lecture 4: How to interact with the investigator-DO's and DON'T's
Lecture 5: What companies should do when the inspection ends
Lecture 6: How to reply to 483's and warning letters
Lecture 7: Legal implications of non-compliance
Lecture 8: Post inspection actions

Day Two
Lecture 1: Why inspections are conducted and by what statutory authority
Lecture 2: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
Lecture 3: What is subject to FDA purview and what's off-limits
Lecture 4: Understand and apply the do's and don'ts and comprehend that preparation is the key to success
Lecture 5: What are the prohibited "Acts" and the enforcement categories that you need to deal with
Lecture 6: 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 7: The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
Lecture 8: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure
Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development

Speaker Profile:
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

Venue, Address and Date:
Held: 6th & 7th February 2014, Singapore
Venue: Mandarin Orchard Singapore
Address: 333 Orchard Road, Singapore 238867

Price: $1595.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until January 10, Early Bird Price: $1,595.00
From January 11 to February 01, Regular Price: $1,795.00

Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: [email protected]
Website: https://www.globalcompliancepanel.com
GlobalCompliancePanel
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