Biotech Comp Trng Gd Bio

All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards. Answering the call for a one-stop training resource that focuses exclusively on this multi-faceted, high-tech industry, Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry provides ready-to-implement training templates that save time and expense without cutting corners on critical elements.

Attached CD-ROM: Why Reinvent the Wheel?
This complete, single-source reference contains 28 complete biotechnology courses and a customizable CD-ROM with hands-on training tools. The book also provides time-saving information on how to orient employees involved in writing and executing batch manufacturing and in-process control documents.
Key Benefits:



Contains adaptable training text, test summaries and papers, test answers, and certificates of completion
Streamlines the training process, maximizing efficiency
Boosts the marketing edge over competitors


This valuable training tool presents step-by-step guidance for optimizing research and development expenditures, avoiding marketing delays, gaining a competitive advantage, reducing product development failures, developing skilled manpower, and maintaining local and international regulatory compliance.

Julphar Gulf Pharmaceutical Industries, United Arab Emirates

Microbial Growth Text
Culturing Microorganisms Text
Bioreactor Configurations Text
Bioreactor Design Features Text
Lyophilization: Growing with Biotechnology Text
Shear Effects in Culture Text
Energy Input in Bioreactors Text
Downstream Processing Text
Mammalian Cell Cultures Text
Plant Cell Cultures Text
Fermentation Text
Characteristics of Cells in Culture Text
Cell Lysis Text
Cells Fractionation Text
Centrifugation Text
Homogenization Text
Refolding of Inclusion Bodies Text
Solubilization and Refolding of Proteins Text
Inclusion Bodies Solubilization Text
Sludge Treatment Text
Freeze Drying Text
Vacuum Drying Text
Diafilteration Text
Partition Chromatographs Text
Adsorption Chromatographs Text
Gel Filteration Chromatographs Text
Techniques of Genetic Engineering Text
Industrial Biosafety Text
Certificate of Attainment
Biotechnology Training Records
Recommended Readings

Appendix A ICH Harmonised Tripartite Guideline

Appendix B Guidance for Industry by U.S. Department of Health and Human Services – Food and Drug Administration – Center for Biologics Evaluation and Research (CBER) – February 1999

Appendix C EMEA European Medicine Agency Guideline

Index