Peihong Liang

owns and oversee GRA device, Regulatory Strategy, and Regulatory Intelligence processes.

Project management for medical device, drug delivery, packaging, and connected-care solutions.

Provide oversight and stewardship to the CT device and drug/device combination processes within PR&D Quality. Build infrastructure, establish new processes, and improve existing processes to enhance process efficiency and ensure CT medical devices compliance.

• Review the CMC submissions including raw material specifications, quality lab testing results, method validations, stability reports, master manufacturing records, executed batch records, packaging records, and supplier’s Certificate of Analysis (COA). • Identify gaps and deficiencies in the CMC contents. Author and issue deficiency reports for dietary supplement manufacturers. • Responsible for the planning and launch of regulatory and pharmaceutical workshops/trainings, aligning the workshop objectives with USP’s global health strategy and focus areas, driving revenue growth, increasing outreach. • Managed 70+ regulatory and pharmaceutical workshops/trainings with proven ability to consistently deliver projects on time and with high quality. • More than doubled the USP training revenue in 2 years. • Quadrupled the USP’s outreach world-wide. • Identify regulatory, compendial, and pharmaceutical training demands both in US and in developing countries; align the planning of the workshops with USP’s global health strategy and focus areas; deliver workshops and forums globally. • Establish and lead complex, matrix-based project teams with diversified team members at different levels of the organizations including internal staff from multidisciplinary departments and external subject matter experts from industry, academia, and regulatory agencies. • Spearhead the launch of web based USP training products. • Effectively collaborate with stakeholders including FDA, RAPS, ASQ, AAPS, Chinese Pharmacopeia, CSFDA, pharmaceutical industries associations, and academia. • Mentored and coached visiting scientists from China, India, Brazil, and other countries.

• Led and managed various Drug Product Development, Manufacturing, and Global Quality projects (QA/QC) supporting clinical trials, formulations studies, stability studies, and manufacturing releases by guiding and influencing project teams, training the team members, developing work plans, implementing work activities, managing workloads, and monitoring work progression. Effectively interfaced with multidisciplinary teams that involved third party testing labs/CRO (Contract Research Organizations), and R&D, QA, QC, CMO, and Regulatory Affairs to deliver each project on time and with high quality. • Oversaw third party lab testing results and led investigations on OOS, OOT and other non-conformance issues. Performed root cause analysis and followed through with CAPA. Presented findings to quality system and management. Provided technical assistance and guidance to contract manufacturing and contract research organizations (CMO and CRO). • Led and participated in periodic internal quality lab audits, and facilitated multiple FDA audits. Authored, reviewed, and revised job-related SOPs to ensure cGMP/regulatory compliance. • Led the Compendia Affair group to assess the in-house analytical methods and specifications against the monographs and the Compendia methods (USP, EP, JP, India and Chinese Pharmacopoeia). Discovered gaps, and developed strategies with Regulatory Affair department to timely resolve issues. • Authored and reviewed the analytical sections of the CMC document for regulatory submission. • Collaborated with cross functional groups at R&D, QA, and Manufacturing to develop Raman and NIR Spectroscopy data base for raw material ID (including excipients and API) and counterfeit sample testing. • Actively contributed to multidisciplinary projects in product development and cGMP manufacturing while interfacing with R&D, QA, QC, Manufacturing, and Regulatory Affair.

Project Leadership Certificate

1. I published a paper for designing a teaching project. 2. Being a teaching assistant helped me to build up my skills in training others. It also helped me with my communication skills with people from various backgrounds. 3. My knowledge and skills in designing analytical studies by using HPLC, GC, UV-Vis, Karl Fisher and TGA equipment were strengthened by teaching and sharing with others.

Graduate research in Spectroscopy field, first author of two publications, excellent graudate honor.