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Batch Record Engineering - Expert compliance with industry and government regulations, integrated SOP for batch record engineering for the Pharmaceutical, Biotech, Vaccine Production industries

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Batch Record Engineering - Expert compliance with industry and government regulations, integrated SOP for batch record engineering for the Pharmaceutical, Biotech, Vaccine Production industries
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Shilay Associates - Home | shilay.com Reviews

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Batch Record Engineering - Expert compliance with industry and government regulations, integrated SOP for batch record engineering for the Pharmaceutical, Biotech, Vaccine Production industries

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Shilay Associates - Home

http://www.shilay.com/capabilities.html

BUSINESS TRANSFORMATION THROUGH BATCH RECORD ENGINEERING. Partnering with the Life Science Industry. BATCH RECORDS - SAI MEMBERS HAVE WRITTEN MORE THAN:. 2500 Solid Dose Batch Records (BRs) i.e. tablet, capsule, IR/DR, spheres. 400 Semi Solid BRs. 25 Vaccine Product BRs. 5000 Medical Devices BRs. View examples of SOP video. SOPs SIMPLIFICATION and OPTIMIZATION. Consolidate, delete, combine, etc. Better use of pictures diagrams, tables. Make more clear and usable. Great training reinforcement tool.

2

Shilay Associates - Home

http://www.shilay.com/index.html

BUSINESS TRANSFORMATION THROUGH BATCH RECORD ENGINEERING. Partnering with the Life Science Industry. US Food and Drug Admininstration. Canada - Health Products and food Branch Inspectorate. United Kingdom - Medicines Control Agency. Ireland - Medicines Board. Japan - Ministry of Health, Labour, and Welfare. Singapore - Health Sciences Authority. ISO9001 and ISO 13485. Canadian Medical Device Regulations (SOR/98-282). EU Medical Device Directive 93/42/EEC. Reduced operator errors and deviations.

3

Shilay Associates - Home

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BUSINESS TRANSFORMATION THROUGH BATCH RECORD ENGINEERING. Partnering with the Life Science Industry. Improved Review and Release Techniques. Implementation Support for Batch Records, SOPs, Log Books and Test Methods. 5582 Forkwood Drive NW, Acworth, Georgia 30101.

4

Shilay Associates - Home

http://www.shilay.com/experience.html

BUSINESS TRANSFORMATION THROUGH BATCH RECORD ENGINEERING. Partnering with the Life Science Industry. Shilay Engineers have 100 years combined experience in redesigning batch records for Pharma, Biotech, Animal Health, and Vaccine Industry. Please allow us the opportunity to meet face to face sharing our models and methodology. Our bedside manner, project skills, dedication and business ethics are cornerstone values that allow us to stand apart. 5582 Forkwood Drive NW, Acworth, Georgia 30101.

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BUSINESS TRANSFORMATION THROUGH BATCH RECORD ENGINEERING. Partnering with the Life Science Industry. US Food and Drug Admininstration. Canada - Health Products and food Branch Inspectorate. United Kingdom - Medicines Control Agency. Ireland - Medicines Board. Japan - Ministry of Health, Labour, and Welfare. Singapore - Health Sciences Authority. ISO9001 and ISO 13485. Canadian Medical Device Regulations (SOR/98-282). EU Medical Device Directive 93/42/EEC. Reduced operator errors and deviations.

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