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Ling Lu

Ling Lu

Design Control Group Lead-Sr Principal Scientist

Pfizer

Greater Boston Area, us

Coaching and leading a group of 4 formulation scientists to drive design control activities, author design history files for combination products according to 21 CFR Part 4 Final Rule; 20 years experience in design controls, product development, quality engineering, regulatory affairs; co-chair of Regulatory & Quality Device ...

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Pfizer

Design Control Group Lead-Sr Principal Scientist

Develop combination product regulatory strategy, design control streamlined process, 21 CFR Part 4 compliant system for combination products, e.g. PFS, drug kits, cross labelled drug delivery products.
Lead design control group, trained and coached design control specialists, formulation scientists and process engineers, supported a dozen development projects going from phase 1, 2, 3 to commercial licensure.
Present and lead discussion on FDA Guidance for glass syringe, injectors, biocompatibility, CCS, CGMP for combination products, ISO PFS standards: ISO 11040-8, 11040-4, 11608 series, ISO 594-1, -2, 80369-1, -7, -20, 8364, 9626, 7886-1, 10993 versus USP <1>, <71>, <381>, <660>, <661>, <788>, design controls versus QbD, case studies on biocompatibility, regulatory queries, and inspection.