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Development of Solid Generic Formulations
Pharma & Biotech

Development of Solid Generic Formulations

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Learn how to establish an effective generic drug development program

Learn how to establish an effective generic drug development program

Learning Objective

Identify possible challenges encountered when moving to a new manufacturing site

Identify possible challenges encountered when moving to a new manufacturing site

Learning Objective

Introduce Quality by Design from the very start

Introduce Quality by Design from the very start

Learning Objective

Find out how to set up a good transfer master plan

Find out how to set up a good transfer master plan

Learning Objective

Explore risks and critical process parameters for a solid dosage form

Explore risks and critical process parameters for a solid dosage form



KEY TOPICS

Effective generic drug development program
Expected Timelines and Influencing Factors
The First Step of Formulation – The importance of the API
BSC Classification
The Roles of Excipients and Equipment
Manufacturing Development
Scale-up and Technology Transfer
Regulatory Requirements

TRAINER

Dr. Laura Buttafoco

Dr. Laura Buttafoco

Protea, CEO

Laura has extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements. This includes writing and revision of CMC regulatory documentation for the drug substance and drug product used in veterinary and human hormonal therapy, antibiotics, statins, vaccines and over-the-counter medications. Laura’s experience brings a unique combination of scientific background and effective communication skills that are well-matched with her international perspective and experience. She was responsible for the outsourcing of all analytical and processing activities related to the development, scale-up, tech transfers and validation of pharmaceutical products within multidisciplinary teams managing in DSM, Janssen and Disphar. Laura also has in-depth and direct experience in collaborating and managing CROs and CMOs in culturally diverse environments, mostly within Europe and Asia (especially India and China). She is certified as an independent ICH-GCO and GLP auditor in clinical trials.

Learn More →