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At the conclusion of this session, participants will be able to:
An overview of ISPE’s Product Quality Lifecycle Implementation® (PQLI®) initiative is provided, including its history, progress, and where it is heading. The PQLI initiative was created to provide guidance on practical implementation of the concepts described in ICH guidelines, focusing on Q8, Q9, Q10 and the future Q11to help ensure product quality throughout a product lifecycle, leading to continuous product improvement.
Any industry professional in a quality discipline.
PQLI has something for virtually everyone from scientists involved in chemical process development and analysis, formulation and packaging development and analysis, CMC project management, technology transfer, validation, CMC regulatory, compliance, manufacturing, quality control, quality assurance, process control, engineering, biotech process development and analysis.
Christopher Potter has BSc and PhD degrees in organic chemistry and has worked for three companies holding senior management positions in CMC pharmaceutical and analytical development, and quality/compliance. Potter was a member of EFPIA’s ad hoc Quality Group from 1996 to 2007, and during this period was EFPIA topic leader for ICHQ6A, Specifications for New Drug Substances and New Drug Products, and ICH Q4B, Regulatory Acceptance of Pharmacopoeial Interchangeability. Potter retired from AstraZeneca and is working as a CMC consultant as well as project managing ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative.
API, Biotech, GCLP, IP, Packaging, PAT, PPD, PM, and SPP