Advanced Pharma Technology Transfer MasterClass - US edition
18-20 March, 2024
Implementation of Quality by Design principles.
This 3 day online course is providing practical insights in the challenges of Technology Transfer and on how implementation of Quality by Design principles.
18-20 March, 2024, Virtual
Time Zone: Eastern Daylight Time (EDT) - UTC−04:00
This 3 day course is providing practical insights in the challenges of Technology Transfer and on how implementation of Quality by Design principles is essential for a successful completion of the transfer and successive validation of a manufacturing process.
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He has held several key roles in Technology Transfer from Project Leader to Program Manager, moving from technical feasibility assessment and tasks coordination to complex multi-sites multi-dosages project management to overall technology transfer company portfolio management (100+ active programs). These include team leading in an Agile framework, financial monitoring, performance management, overall risks management and mitigations, reporting to executive and development of strategy and relationship with key stakeholders (i.e Regulatory Agency, Sponsors, Suppliers, Executives).
As a result of his ability to successfully execute all stages of the technology transfer process, he was promoted from site roles to global roles, with the opportunity to work on Technology Transfer Policy harmonization and best practices improvement and sharing. He successfully covered several dosage forms projects, from Oral to
Combination products with a strong expertise in Sterile.
Director roles in Business operations and innovation and strategy gave Mirko a full overview of the technology and pharma space, strengthen his ability to successfully lead complex team and organization (500+ reports). He is also part of the PDA (Parenteral Drug Association www.pda.org) since 2005 and is now member of the Board of Director. He led the writing task force who produced the Technical Report 65 (TR-65 Risk Management in Technology Transfer), and he is currently the PDA Europe Trainer for Technology Transfer. Mirko is leading the PDA Technology Transfer Interest Group (TT IG) for Europe which has the mission to define, share and implement best practices in the industry.
Who should attend?
• CMO Managers
• Technology Transfer Specials
• Manufacturing Project Managers
• Manufacturing Management
• Process Scientists
• Quality Assurance Managers
• Process Scientists, Process Leads
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Manager, Senior Investigator
MT Sword Laboratories (BMS)
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Years of experience
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