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GlobalCompliancePanel, United States
2012-03-29
Overview: United States Food and Drug Administration ("FDA") is the federal agency responsible for ensuring that foods are safe; drugs for human and animals, biologics and medical devices are safe and effective; electronic products that emit radiation as well as cosmetics are safe.
As rules and regulations help FDA ensure that regulated products are safe and effective, it is imperative we understand the applicable regulations (Title 21 of the Code of Federal Regulations for Food and Drugs "Title 21: Food and Drugs") and also be able to accurately interpret the said regulations to better meet the regulatory requirements necessary for FDA approval or clearance to market drugs, biologics, medical devices and food additives. In this webinar, the Title 21: Food and Drugs, the codification of the general and permanent rules and regulations (sometimes called as administrative law) for Food and Drugs, will be discussed.
Why should you attend: If you don't know the answers to the following questions, you should attend this webinar.- Who makes federal regulations?
- Who makes FDA regulations?
- How the federal regulations are organized?
- Which provisions of FDA regulations are applicable for regulating the following?
- Food
- Drugs
- Biologics
- Medical devices
- Cosmetics
- Combination products
- What regulatory requirements exist for the following?
- Good Laboratory Practice (GLP)
- Investigational New Drug Application (IND)
- Investigational Device Exemption (IDE)
Areas Covered in the Session:- Title 21: Food and Drugs
- Who makes it?
- How it is organized?
- How often it is revised?
- Food
- Drugs
- Biologics
- Medical Devices
- Cosmetics
- Good Laboratory Practice (GLP)
- Investigational New Drug Application (IND)
- Investigational Device Exemption (IDE)
- Recent enforcement actions for food, drugs, biologics and medical devices, etc.
Who Will Benefit:- Regulatory Affairs Associates, Specialists, Managers, Directors and VPs
- Quality Associates, Specialists, Engineers, Managers, Directors and VPs
- Compliance Specialists and Officers
- Research and Development (R&D) Managers, Directors and VPs
- Product and Development (P&D) Managers, Directors and VPs
- Complaint Handling and Risk Management Managers and Directors
- Sales and Marketing Managers and Directors
- Clinical Affairs Managers and Directors
- Site Managers, Directors, and Consultants
- Senior and Executive Management
- Legal Counsel
- Anyone Interested in Learning About US FDA Regulations
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.
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Deadline for Abstracts:
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2012-03-29
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Registration:
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Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407 Fax: 302-288-6884
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E-mail:
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webinars@globalcompliancepanel.com
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