Corazon Lai Email & Phone Number

San Francisco Bay Area

At Purely Cloud we are the leader in Microsoft private cloud services. We empower businesses to run better through simple, innovative technology solutions. Our mission is simple: Provide our clients with the very best customer service experience, the most reliable secure computing environments, on scalable systems that grow with the speed of business. We provide creative solutions that make every business run better to make profits soar. One critical thing businesses must do in today's economy is focus their strategic resources in efforts that differentiate their businesses from their competition. This has led many to seek out an IT partner to help them with day-to-day management of their IT infrastructure. This allows them to have their IT leadership focused on initiatives that make a difference to their customers and their topline growth. Our company is a Microsoft Partner holding competencies in: - Management and Virtualization - Server Platform - Midmarket Solution Provider - Hosting

South San Francisco, Ca

Oversees and supports QAU programs including:-GLP Archives: Ensure that the GLP Archives is a compliant, comprehensive, and rigorous program for the management of study records and raw data.-Master Schedule: Ensure that a robust process is in place for maintaining an accurate Master Schedule Sheet.-Controlled Documents: Provide SOP system management for departments involved with the conduct of GLP studies.-Training: Manage the company-wide GLP training curriculum; Ensure that all training is accurately documented and maintained.-System Assessments: Oversee the assessments of various processes to aid with improvement and efficiency.

South San Francisco, Ca

- Oversees and supports Development Quality Assurance Programs such as SOP System, Inspection Management, Assessments, Programs Support, Training and Reviews.- Works closely with functional area management to identify procedural and systematic compliance risks and recommend practical, risk-based solutions that complement functional area business practices.- Functions as a quality partner for programs, projects and initiatives in the Development Organization.- Tracks the execution of change efforts and reports on progress, issues, and challenges.- Accomplishes results through lower level supervisors or experienced employees who often exercise significant independence.- Assists with department strategic planning, recruiting, and developing business processes.

South San Francisco, Ca

- Serve as compliance representative on multiple pharmacology sub-teams; provide GLP guidance to ensure study compliance with regulations. Provide protocol input, write and review SOPs.- Identify compliance risks, provide consulting to GLP study personnel and management on complex or critical compliance issues, e.g., Nonclinical Master Schedule. Lead the effort the DevIS and BioInformatics to identify and resolve problems within current LASAR/Master Schedule system.- Participate in assessments of critical processes such as GLP Sample Handling; collaborate with various departments, identify areas for improvement, and write comprehensive report for distribution.- Prepare for regulatory inspections by ensuring that functions and personnel are inspection-ready. Key participant in 2005 FDA inspection. Lead initiative to increase efficiency during inspections by collaborating with DevIS and CIT to design a web-based system.- Conduct GLP training courses, e.g., Management Responsibilities, Basic GLP and 21 CFR Part 11 Overview.

South San Francisco, Ca

- Responsible for coordination and submission of FDA information packages including those in preparation for FDA meetings leading to the approval of Avastin. Accountable for accurate documentation of meetings. Approved and tracked all regulatory investigator site documents and drug release for Avastin trials and ISTs. Served as primary contact for Canadian CTA and NIH IND.- Primary regulatory representative on Avastin studies; attended clinical and pharmacology sub-team meetings to provide regulatory guidance.- Assisted in the BLA filing of Avastin, responsible for compilation of nonclinical sections. Managed submissions in fulfillment of post-marketing commitments.

South San Francisco, Ca

- Managed the development, implementation, and conduct of GLP compliance programs, projects, and activities (domestic and international). Provided company-wide training of GLP regulations, guidelines, policies, industry standards and their interpretation and application. Planned and conducted inspections and audits of various departments and CROs. Cross-trained in GCP Compliance, prepared clinical sites for FDA inspection and performed GCP audits of facilities. Served as compliance contact for Pharmacological Sciences, Medical Affairs, and Regulatory Affairs.

South San Francisco, Ca

- Performed Assays (IL-6, sICAM, Beta-2 Microglobulin, Neopterin) and monitored results in support of the IFN-gamma renal cell cancer trails. Created a database to enable efficient tracking of results. Developed short-term culture assay to help identify and characterize survival factors for photoreceptor cells in conjunction with the gene therapy program. Techniques included dissection and separation of neural retina from other ocular tissues derived from rat and chicken, cell culture of retinal neurons, preparation of cultured cell for visualization using conventional light microscopy, basic immunohistochemistry, and fluorescence microscopy.

South San Francisco, Ca

- Developed and executed bioassays using K562 cells for erythropoietic activity and primary rat pituitary cultures for FSH in support of purification and expression. Developed methods for assessing direct effects of activin on primary cultures of hepatocytes and on growth of liver tumor cell lines. Conducted osteogenin bioassay by bone induction in rats. Performed surgeries for Genentech's "First Flight" NASA Space Shuttle Mission STS-41 at Kennedy Space Center, Cape Canaveral Air Force Station, Florida.

South San Francisco, Ca

- Developed and optimized relaxin bioassay. Assayed unknown relaxin samples, determined affinities of relaxin from several species. Evaluated neutralizing ability of several antibodies.

Palo Alto, Ca

Menlo Park, Ca