Frank W Email & Phone Number

Hangzhou, Cn

Hangzhou, Zhejiang, China

Takes part in the design and building of biological production plant.Establishes the Quality System of the company and builds the QA team.Responsible on the Validation System building and ensures the validations and qualifications performed.Reviews the URS, takes part in the technological interchange and selection on the equipments, instruments and facilities.Responsible on the GMP operation in the company.Responsible on the handling of deviations, change controls and OOS/OOT.Responsible on the suplier managerment.Contacts with the Medical Products Adminstration.参与生物药工厂设计，跟进项目实施进度参与公司质量体系的建设，审批公司内GMP文件参与质量管理文件的起草，负责制定公司内的确认/验证管理制定负责制定确认/验证主计划和年度确认/验证计划，组织跟踪确认/验证工作的实施组织建立公司验证体系，组建验证团队审核URS、DQ、FAT、SAT、IOPQ等确认/验证方案和报告负责监督、督促、指导公司内各部门GMP运行负责组织对物料供应商进行评估和管理参与产品转移工作，组织跟进产品生产组织对各项偏差、变更、OOS/OOT进行调查处理及跟踪与当地药监部门沟通

Suzhou, Jiangsu, China

 In charge of the management of QA, QC and technology Dept. In charge of the quality system working of the company. In charge of the GMP certificate. Including the application, site inspection, respond of the observation report.  Release the product, including the solid product, small volume injection product, and lyophilized product Review and approve the validation plan and related document. Review and approve all of the SOPs Review and approve the validation protocol and report, including the process validation, equipment and instrument qualification, cleaning validation and test method validation/verification. Approve the protocol of stability testing Approve the product annual review Approve the suppliers of raw material and package material Approve the GMP self-inspection plan and report Approve the plan and report of the product transfer Perform the GMP training for staffMain Experiences GMP inspection for lyophilized product (09/2018) Participate in the GMP audit inter-company in Yangtze River Group. 2 lyophilized products transfer and 1 solid product transfer, from other company to Haian Pharma.  Application batches production of 3 new products, and scale up of 6 new product.

Hangzhou, Zhejiang, China

To improve the quality system of solid drug product manufacturing. Inspecting the GMP compliance, discovering the deficiencies and performing the CAPA For GMP audit CFDA. Including preparation before the inspections, company with the inspector and answering questions during the inspections, preparing the CAPA after the inspections.Reviewed the qualification protocols and reports for the utility, equipments and instruments. Review the protocols and reports for the product process validation and cleaning validation.Review the Change Control Applications and follow up the results.Participate in the GMP self-inspection. Confirm and follow the CAPA.Participate in the investigation of deviations and OOSs and review the reports. Confirm and follow up the CAPA.Participate in the Quality Consistency Evaluation of Generic Drugs. Including scaling-up, process evaluation and process validation.

Hangzhou, Zhejiang, China

Mantain ant improve the quality system of company.Acted in the GMP inspection for oral solid product based on CFDA GMP（2010）, in 2012.Acted in the GMP inspection of US FDA for oral solid product as Preapproval Inspection (PAI) and Routine GMP inspection, in 2014 and 2016.Acted in the GMP audit of clients (from USA and EU)Participated in the premise modified. Drafted the IQ/OQ/PQ of HVAC and arranged the qualification performing.Participated in a number of products technology transfer and the ANDA projects.Relaesed the product.

Hangzhou, Zhejiang, China

Acted in the construction of the new company. Included the facility, utility, equipment/instrument and quality system.Acted in the GMP inspection for oral solid product based on CFDA GMP, in 2010.Acted in the GMP inspection of US FDA for oral solid product as Preapproval Inspection (PAI), in 2011.Acted in the GMP audit of clients.Drafted the IQ/OQ/PQ of HVAC and arranged the qualification performing.Participate in the qualifications of the utility, equipments and instruments. Participate in the product process validation, cleaning validation and analysis method validation/verification.Participated in the products technology transfer.

Hangzhou, Zhejiang, China

For GMP Compliance of manufacturing of API and oral solid product For GMP audit of FDA and CFDAReview the qualifications and validationsReview the Change Control ApplicationsGMP Self InspectionReview the Deviation Reports and OOSManagement of the suppliers of API, excipient and package materialsProducts release for API products and finish products