Process Development of Solid Dosage Formulations

CMC

Pharma & Biotech

Process Development of Solid Dosage Formulations

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

WHY SHOULD YOU ATTEND?

Overcome the challenges of tablet development

Get a structured overview of how to establish an effective generic drug development program.

Introduce Quality by Design from the very start

Identify possible challenges encountered when moving to a new manufacturing site.

Find out how to set up a good transfer master plan

Realize the importance of the excipient grades for the success of a formulation.

Explore risks and critical process parameters

Get an overview of possible variations of a registration dossier in EU and US.

OUR ONLINE TRAINING EXPERIENCE INCLUDE

Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.

All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.

Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.

LEARNING OBJECTIVES

A New Generic Drug: Expected Timelines and Influencing Factors

Considerations in the Selection of a Generic Drug Product. Selection of a CMO. Meeting Target Product Profile.

The First Step of Formulation

The importance of the API for the formulation. Case study: The challenges of changing API supplier.

Biopharmaceutics Classification System (BCS)

A need for Bioequivalence studies. Biowaiver considerations. Practical examples and potential risks factors.

The Role of Excipients

Excipients and technology transfer. Case study: How to select the best excipient grade for your formulation?

Stability Studies Requirements

Stability studies during the product life cycle. Stress testing and ICH stability

The Role of Equipment

Process selection criteria for solids manufacturing. Current trends in oral dosage forms.

Challenges of Process Scale-up and Technology Transfer

Powders and equipment: A challenging relation. Risks and critical process parameters for a solid dosage form.

Generic Registration Regulatory Requirements

Elements of a registration dossier in EU and US. Module 3 and overview of the possible variations to submit.

WHO IS THIS TRAINING FOR?

Designed for professionals who want to enhance their expertise and advance their careers

Formulation Managers

Manufacturing Managers

Pharmaceutical Technologists

Process Development Scientists

Process Engineers

CMO Managers

Regulatory Affairs Managers

Quality Assurance Managers

KEY TOPICS

Effective generic drug development program

The first step of formulation - the importance of the API

BSC classification

Scale-up and technology transfer

Expected timelines and influencing factors

The roles of excipients and equipment

Manufacturing development

Regulatory requirements

TRAINER

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 →