Insights in Analytical Development Mastery - EU Version

27-28 November, 2024

Key aspects for the justification of specification

ONLINE TRAINING | 27-28 November, 2024

Starting time: GMT 08:00 a.m.

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Key Takeaways

Regulatory guidance documents

How to interpret the guidance documents

Analytical documentation

Analytical procedure life cycle

masterclass in pharma

Overview

The field of analytical development as part of the development of a new or generic drug product covers a huge range from the translation of the Quality Target Product Profile (QTPP) into the Analytical Target Profile (ATP) over the entire analytical procedure life cycle (i.e., development,validation, transfer, and maintenance of new analytical procedures) to key contribution to the control strategy of the commercial product (including definition of Critical Quality Attributes (CQAs), establishing of specification and justification for specification). In addition to these key elements for a successful development of a drug product analytical development is a key player in the stability studies and for the definition of the shelf-life of the medicinal product. Several regulatory documents are around analytical development which provide guidance to the key elements to this CMC topic such as the ICH guidelines for Pharmaceutical Development (Q8 (R2)), Analytical Development (Q14), Method Validation (Q2 (R2)), Specification (Q6A & Q6B), Impurities of new drug substances and products (Q3A & Q3B), and Stability testing (Q1A to Q1E). In addition, further scientific information can be found in pharmacopeial general chapters of the USP. These guidance documents form the basis of this course around analytical development. In detail, the focus of this course is on the specification of drug substances and products and its justification, determination of Critical Quality Attributes (CQAs), life cycle of analytical procedures, analytical documentation in terms of procedure content and validation / transfer of methods, and stability studies for drug substances and products. Furthermore, the analytical aspects of the control strategy will be covered as well analytical documents for the submission.

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MEET THE TRAINER

MANFRED FISCHER

General Manager
Manfred Fischer Consulting

Dr. Manfred Fischer is a Biophysical Chemist. He has more than 30-year experience in the pharmaceutical industry, mainly in the CMC arena covering analytical / formulation development of new and generic products and Quality Control of medicinal products. He started his career in the pharmaceutical industry at AstraZeneca with a leadership role in analytical development. As the next steps in his professional journey, he served in several managerial and leadership roles in analytical development and quality control at AstraZeneca, AltanaPharma, and Eli Lilly. In 2007 Manfred Fischer joined Skyepharma (later acquired by Vectura), Switzerland as head of analytical development. In 2017 he became VP of pharmaceutical development of inhalation drug products at Vectura. He is the founder and General Manager of Manfred Fischer Consulting, a pharmaceutical company focusing on analytical, formulation and device development consulting.

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Reasons to attend a masterclass

Practical knowledge

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Interactivity

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World-class trainers

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Networking

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Who should attend?

-Analytical Development
-Formulation Development
-Project Management
-Pre-clinical Development
-Clinical Development
-CMC Regulatory Affairs
-Quality Control
-Quality Assurance
-Drug Substance Manufacture
-Drug Product Manufacture