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Hot Topics Workshops focus on workforce development training associated with Regulatory Compliance, Regulatory Affairs and Quality Assurance. The courses help employees develop appropriate GMP strategies and documentation for successful product manufacturing, technology transfer, and regulatory filings, from discovery to commercialization. Our workshops are designed to provide a forum for interactive learning, and are practical and reasonably priced.
 2009 BIOFILM CONFERENCE
In response to numerous requests, SCI, Inc, through its Hot Topics Workshops, is expanding its course offerings through a series of collaborations with other industry professionals and organizations. One of those collaborations is with the Campbell University School of Pharmaceutical Sciences - Product Development Training Institute and BTEC.
 View the announcement about this upcoming event
Other topics can be customized to fit your needs: |
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GLP Basics |
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GMP Basics |
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Getting to Know the FDA and the Regulatory Process |
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From Preparation of the Common Technical Document (CTD) to European Marketing Authorizations: Key Requirements |
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From Discovery to Commercialization - Key Regulatory Requirements |
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This workshop provides the ultimate step-by-step guidance on how to integrate GMPs into product development in a continuum fashion to ensure successful regulatory approval and expedite product launch. |
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Next public workshop: To Be Announced |
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Location: To Be Announced |
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Download Registration Form |
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Key Considerations for Successful Technology Transfer and Outsourcing |
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This workshop focuses on early planning of all activities supporting technology transfer. It includes recommendations for selection of key materials and process decisions in concert with Quality Assurance, Quality Control, Validation, and Regulatory Affairs functions. |
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Next public workshop: To Be Announced |
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Location: To Be Announced |
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Download Registration Form |
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Making Challenging Decisions to Take Products from the Bench to the Clinic |
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Documentation Management and Control |
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This workshop provides detailed guidance on developing and managing a documentation system to support product development and commercialization. It includes instructions on Good Development Practices (GDP) for Policies, SOPs, STMs, Technical Reports, Notebooks, Validation Protocols, and other GMP documents. |
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Next public workshop: To Be Announced |
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Location: To Be Announced |
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Download Registration Form |
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The Basics for Effective Project Planning |
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This workshop focuses on the selection and implementation of project planning and management tools that can help make the product development process more efficient. Many of these tools are computer driven and must comply with Part 11. |
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Next public workshop: To Be Announced |
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Location: To Be Announced |
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Download Registration Form |
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Integrating GMPs, Quality Assurance and Financial Management in the Regulated Environment |
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Establishing the Validation Program at a Start-up: Key Considerations. |
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| For more information on In-house training, contact (919) 460-3900 or e-mail us at cwagner@hottopicsworkshops.com |
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