These workshops are designed to provide a forum for interactive learning on many of the current hot issues affecting the biological, biotechnology and vaccine industries, including the topics shown below. We provide specific guidance on how to prepare a company to take a product from Discovery to Commercialization in compliance with worldwide regulatory requirements, in a timely manner. The complete series focuses on regulatory affairs and regulatory compliance requirements and provides tools to help ensure acceptable levels of compliance at each individual stage of process development. We can customize any workshop to fit your company needs.
All workshops include hands-on activities and the provision of templates, checklists and other useful tools.
This workshop provides the ultimate step-by-step guidance on how to integrate product development and regulatory requirements considering risk assessment, regulatory requirements for documentation, validation, technology transfer and ultimately regulatory filings to ensure successful regulatory approval and to expedite product launch.
This workshop provides guidance on key regulatory requirements for successful submissions throughout the different phases of product development. Specific discussions focus on pre-submission meetings, the Common Technical Document and Registration Procedures in the US and Europe.
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. It discusses the importance of team work, Tech Transfer Master Plans, impact of changes, Quality by Design, staffing and scheduling considerations, among other topics.
This workshop provides guidance on how to bring Quality Assurance and Validation early into product development. It presents points-to-consider for integrating these functions into the risk assessment and development processes, for new products or for changes to already commercialized products.
This workshop provides detailed guidance on developing and managing a documentation system to support the start-up activities to transition into commercialization. It includes instructions on Good Development Practices (GDP) supported by Policies, SOPs, STMs, Technical Reports, Notebooks, Validation Protocols and other GMP documents.
All involved in product/process development, including but not limited to: Regulatory Affairs, quality assurance, business development, quality control, project managers, R&D, manufacturing and validation/engineering professionals.