Introduction/Objective of the Seminar:

Current GMP requirements for test method validation are quite clear: Methods used for GMP product testing must be validated to demonstrate they can produce accurate and reliable results. But FDA and EU guidances are less clear about method ‘validation’ during product development. On one hand, they indicate method validation is an evolving process, but on the other they state that method validation data should be available upon request at Phase 2 and Phase 3. These guidances also indicate that test methods only need to be qualified for Phase 1 (except safety methods, which do require validation prior to Phase 1). Methods used only for product or process characterization, comparability or similarity also need to be qualified to demonstrate they are scientifically sound.  Some of these methods will start out in non-GMP labs, then transfer to GMP labs; others will only ever be used in non-GMP labs. But during development, even data generated in non-GMP studies are critical for making process and product decisions, and are reported in product dossiers as supportive information. Although there is guidance on lab data integrity in GMP labs, there are no current guidance documents on data integrity in non-GMP labs. 

The Seminar will cover:

• Overview of ICH, FDA and EU guidance documents associated with method validation and data integrity for in-house and contract testing labs
• Outline of types of test methods typically used with biotech/biosimilar products for characterization, comparability, similarity, release and stability testing
• Illustration of typical method lifecycle events for test methods (optimization, qualification, validation, method changes, method transfer, method replacement)
• Differences in study designs between qualification, validation, verification, tech transfer and bridging for biotech/biosimilar products
• Overview of data integrity expectations for GMP analytical testing labs
• Risks to data from non-GMP R&D labs at each phase of development and for key CMC analytical studies
• Illustration of best practices for lab quality and data integrity for non-GMP R&D labs

Target audience:

• Analysts from R&D (non-GMP) and QC (GMP) laboratories
• Process development scientists conducting process design, QbD, PPQ and CPV studies
• QA reviewers of analytical data from key CMC process and product studies
• RA managers of CMC analytical and stability dossier sections and updates
• CMC project managers for pre- and post-approval activities
• Personnel involved with in-house testing and/or contract testing facilities

Introduction/objective of the Seminar:

The successful development of a pharmaceutical product requires not only good science, but also compliance with FDA regulatory expectations. This course will include a comprehensive review of the chemistry, manufacturing and controls (CMC) section of regulatory filings, with a focus on phase appropriate requirements. The level of detail that must be included in the filing will be discussed as well as systems and controls that must be in place in the manufacturing setting. Topics such as process development, analytical development, good manufacturing practices (GMP) and good laboratory practices (GLP) will be discussed in the context of the stage of drug development. Regulatory strategies for navigating the path to approval will also be discussed. This course is intended to provide participants from all facets of the pharmaceutical and biotech industry with a broad understanding of regulatory requirements across the product development lifecycle. 

The Seminar will cover:

• The evolution of drug compliance in the US
• FDA structure and function
• The product development timeline from IND to commercialization
• Special considerations for newer treatment modalities
• Good laboratory practice
• Good manufacturing practice
• Compliance across the product development lifecycle
• The CMC section of the initial IND
• Meetings with FDA during drug development
• The BLA, NDA and beyond