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Performed internal audits of maintenance, AME, and Plant Services Support SOPs, PM Activities, and Computerized Maintenance Management Systems (CMMS) reports, which resulted in revisions to Maintenance and five SOPs.

The company was started to develop my intellectual property and as the inventor and the expert on the product I am the most qualified to be the CSO. I am the person that must answer all scientific question that come up and solve all technical question regarding the development of the product.

as the holder of the technology and patent I am the person who must advise my partners about the technology

assist with closure of concent degree

This company was formed to manage and develop my intellectual property, which is has three patents . We are currently working on acquiring several other products

management and devlopment of intellectual property

- Performed internal audits of maintenance, AME, and Plant Services Support SOPs, PM Activities, and Computerized Maintenance Management Systems (CMMS) reports, which resulted in revisions to Maintenance and five SOPs.

- I wrote validation documents for the validation of two quality software packages including FMEA and Quality review.- I performed the Quality audit of all current software packages for revision of the Master Validation Plan for Zimmer Spine in Minneapolis, MN- I wrote the URS, IQ, OQ, and GAP analysis for an ERP program used in multiple sites.- As recommended by GAMP 5 risk mitigation and client SOPs, I preformed FMEA prior to my authoring and executing protocol test scripts.

I wrote validation documents for the validation of two quality software packages including FMEA and Quality review.I performed the Quality audit of all current software packages for revision of the Master Validation Plan for Zimmer Spine; I wrote the URS, IQ, OQ, and GAP analysis for an ERP program used in multiple sites.As recommended by GAMP 5 risk mitigation and client SOPs, I preformed FMEA prior to my authoring and executing protocol test scripts.

I performed the Quality audit of all existing validation to determine the extent of validation required to bring the systems into compliance with the standards of both FDA and ISO (13485).I wrote the Process Validation Plan for the packaging Process.I wrote the IQ, OQ and the test method validation for 4 pieces of test instruments.I managed the 4 members of the team involved in the Validation of the packaging equipment.

- I performed the Quality audit of all existing validation to determine the extent of validation required to bring the systems up to standards of both FDA and ISO (13485).- I wrote the URS, IQ, OQ and PQ for 5 pieces of packaging equipment and 8 in process test instruments.I Was also charged with performing a gap analysis on all current validation- I wrote the test method validation for 4 pieces of test instruments.- I Managed 4 members of the team involved in the Validation of the packaging equipment.

- I identified all GMP capital equipment and their validated status, then wrote a Master Validation Plan that prioritize all required validation of equipment.

I identified all GMP capital equipment and their validated status, then wrote a Master Validation Plan that prioritize all required validation of the equipment.

- I developed the Software Validation Process and documentation templates for SAP Software Validation - Wrote the SOP for control of Software Validation Process and designed and developed the templates for Software Validation Process. - Wrote the validation of the infrastructure master validation plan for the new Cardinal Health building in San Diego, CA. - Wrote the Validation Master Plan for phases 1 (Communication) and 2 (computer wiring) of this new building infrastructure move in.

I developed the Software Validation Process and documentation templates for SAP Software Validation Wrote the SOP for control of Software Validation Process and designed and developed the templates for Software Validation Process. Wrote the validation of the infrastructure master validation plan for the new Cardinal Health building; Wrote the Validation Master Plan for phases 1 (Communication) and 2 (computer wiring) of this new building infrastructure move in.

- I performed internal audits of computer systems validation (CSV) system life cycle documentation (IQ, OQ, PQ) for 18 systems and made recommendations to for their remediation. In addition I followed up to ensure that all recommendation were complete or scheduled for completion.

I performed internal audits of computer systems validation (CSV) system life cycle documentation (IQ, OQ, PQ) for 18 systems and made recommendations to for their remediation. In addition I followed up to ensure that all recommendation were complete or scheduled for completion.

- I did on-site audits of computer systems validation (CSV) system life cycle documentation (IQ, OQ, PQ) for five (5) US, two (2) Puerto Rico, three (3) Ireland, one (1) Germany, one (1) Belgium, one (1) Singapore and one (1) Chinese Schering-Plough sites which resulted in positive inspections from FDA and GQAC (Schering’s third party Auditing Team).- As required at the above listed sites I revised Validation Documentation to bring them into compliance with the current FDA and GQAC requirements. - I evaluated legacy computer systems used for formulation and dosage preparation for coating, filling, packaging lines, and autoclaves. - I also wrote and executed retrospective validation documents (AIFDS, IQ, OQ, Gap Analysis, RTM, VSR) to bring the packaging systems into compliance.

I did on-site audits of computer systems validation (CSV) system life cycle documentation (IQ, OQ, PQ) for five (5) US, two (2) Puerto Rico, three (3) Ireland, one (1) Germany, one (1) Belgium, one (1) Singapore and one (1) Chinese Schering-Plough sites which resulted in positive inspections from FDA and GQAC (Schering's third party Auditing Team).As required at the above listed sites I revised Validation Documentation to bring them into compliance with the current FDA and GQAC requirements. I evaluated legacy computer systems used for formulation and dosage preparation for coating, filling, packaging lines, and autoclaves. I also wrote and executed retrospective validation documents (AIFDS, IQ, OQ, Gap Analysis, RTM, VSR) to bring the packaging and manufacturing systems into compliance.

- I inspected 15 to 20 study protocols. - I reviewed and approved 25 to 35 test method validations.- I trained all in-house personnel (35 to 45 personnel) on how to maintain GLP/GCP compliance.- I conducted audits of contract research organizations (CRO) employed by BA

I inspected 15 to 20 study protocols. I reviewed and approved 25 to 35 test method validations.I trained all in-house personnel (35 to 45 personnel) on how to maintain GLP/GCP compliance.I conducted audits of contract research organizations (CRO) employed by BA

- I developed and validated all procedures for in process and release testing for the drug Orpharm.- The QA and QC departments were under my supervision and direction.- Schedule two (2) pharmaceutical drug manufacturer of the first methadone alternative drug approved by FDA- Drug (Orlaam) was approved by FDA in a record 18 days.manufacturing of a Schedule II “API”. In addition the filing of the NDA was completed, during my tenure as Director we were required to file a MDF (Master Drug File). I worked directly and managed the final draft of the MDF. Because this was a Schedule II product I dealt with both FDA and DEA on a regular basis. As Director of Quality I also was in charge of Regulatory Affairs and reviewed all filings to both agencies. In the later part of the production of the product we were exporting to Europe and the start of the ICH.

I developed and validated all procedures for in process and release testing for the drug Orlaam.The QA and QC departments were under my supervision and direction.Schedule two (2) pharmaceutical drug manufacturer of the first methadone alternative drug approved by FDADrug (Orlaam) was approved by FDA in a record 18 days.

- I established this laboratory. This laboratory was the first private veterinary laboratory in the Unites States.- I developed micro techniques because of the small blood volume of most domestic pets.

I was hired to be the night emergency laboratory technologist supervisor and trainer