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Microbiology Network - Consulting Services | The Microbiology Network: Dedicated to the improvement of regulatory science and compliance

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PMFList Frequently Asked Questions. Mock FDA Facility and Lab Audits. Audits are available for laboratory, facility, pharmacy or 503B concerns. Development of a contamination control plan. Is critical to the success of aseptic, terminal sterilization and non-sterile manufacturing facilities. Microbiology Network can provide a team of consultants, each e. Environmental Monitoring for Sterile and Non-sterile Manufacturing. There is a great deal of interest in the topic of Objectionable Organisms in the reg...

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Mock audits and PAI Preparation GMP cGMP Quality Assurance | The Microbiology Network: Dedicated to the improvement of regulatory science and compliance

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PMFList Frequently Asked Questions. Mock Audit services are offered by a collaboration of experienced, independently successful CGMP Quality consultants. The team assembles the requisite skill sets for the particular job and can handle the largest facility audit or the start-up who wants a quick review prior to the Agency visit. Identify the deficiencies in your Quality CGMP in time to work on them before the FDA arrives. Scott Sutton, Ph.D. Over 30 years in contamination control measures (sterile, asept...

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Exhibition | Outsourced Pharma Conference & Exhibition

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Outsourced Pharma conferences form intimate and impactful leadership communities for sponsors and suppliers. It’s where pharma and biotechs engage directly in dialogue with contract service providers, leading to business opportunities on both sides. Which CMOs have the capabilities of handling your production processes? Is there someone new to discover? B Braun Medical OEM. Dottikon ES America, Inc. Richter-Helm BioLogics GmbH and Co. KG. SafeBridge Consultants, Inc. Dottikon ES America, Inc. Alcami is a...

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Investment Focus | Ampersand

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Accelerating Growth with Healthcare Entrepreneurs. Healthcare. It's our passion and our expertise. Click for more information. Ampersand Case Study: Viracor-IBT Laboratories. Medical Devices and Components. Ampersand has over two decades of experience in helping build middle market healthcare companies into market leaders. We focus on EBITDA-positive companies that provide products or services within several key healthcare sectors, including laboratory testing services, laboratory products, contract ...

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Consulting Services | The Microbiology Network: Dedicated to the improvement of regulatory science and compliance

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PMFList Frequently Asked Questions. Choices of consultants and breadth of consulting expertise. That the Microbiology Network, Inc. has to offer. Quality Systems reviews - Mock FDA Audits. Our team of CGMP consultants and trainers stands ready to help you. Call us. The first consultation is free. What our clients say. Check back frequently for new additions to the MicroNet Blog service. A Holistic View of Bioburden Contamination Control. 2015 LER Conference at the Bacterial Endotoxin Summit. QC Microbiol...

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Mock FDA GMP Audits | Get GMP Audit Done by Leading GMP Consultants | The Microbiology Network | The Microbiology Network: Dedicated to the improvement of regulatory science and compliance

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PMFList Frequently Asked Questions. Compliance has to make sense from both a scientific and a business perspective. Take advantage of the extraordinary breadth of skills offered by this experienced team with seasoned, proven advice. Regulatory and cGMP Compliant Document Review and Preparation. In addition to working directly with pharmaceutical, biologic, medical device, and dietary supplement companies, the Microbiology Network delivers support to venture capital firms or other companies seeking acquis...

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Insourcing Microbiology Chemistry Laboratory Expertise

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PMFList Frequently Asked Questions. Insourcing Technical Expertise for the Pharmaceutical Industries. Insourcing allows tighter control of quality and avoidance of hidden costs of outsourcing to China and India ( Stanton 2014. Supply chain concerns eliminated. Minimize communication issues with all technical resources at a single site. Avoid co-employment issues with temps. Utilize available facility space. All work under a single Quality system. Avoid high turn-over rates common with temps. Scott's work...

microbiologynetwork.com

Consultant Directory | The Microbiology Network: Dedicated to the improvement of regulatory science and compliance

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PMFList Frequently Asked Questions. Search for a consultant by the following Topics of Interest. You may select more than one. CMO Scale-up and Process Development. FDA Preparation and Response. Procedures to Limit Microbial Contamination. Media Fills and Validation of Sterilization. CSP, BUD and Sterility Tests. BUD and Stability Studies. Facility Design, PEC and Smoke Studies. Audit/Control of Outsourced Services (Contract Labs). Sterility Assurance (Sterile Products). Laboratory Testing and Data Review.