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SMB Validation and Compliance Group

Designed to efficiently assist customers in getting equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled.

http://www.cgmpengineering.com/

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SMB Validation and Compliance Group | cgmpengineering.com Reviews
<META>
DESCRIPTION
Designed to efficiently assist customers in getting equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled.
<META>
KEYWORDS
1 SMB
2 SMB Validation
3 smbvalidation
4 Compliance
5 Qualification
6 Validation
7 IQ OQ PQFDA
8 21 CFR Part 11GAMP4
9 ISPE
10 GXP
CONTENT
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auditing services,quality plans,validation master plans,protocol,generation and implementation,summary reports,computer system validation,project management,equipment/process specification,urs generation,frs generation,dds generation,services,markets
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SMB Validation and Compliance Group | cgmpengineering.com Reviews

https://cgmpengineering.com

Designed to efficiently assist customers in getting equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled.

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cgmpengineering.com cgmpengineering.com
1

SMB Validation and Compliance Group

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

Validation and Compliance Group Inc. Ldquo;Our ‘trademark’ is our understanding that ‘Validation is a Regulatory Requirement within a Business Environment, not a Science in itself.’ We understand that Pharmaceutical and Medical Device manufacturers purchase equipment in order to run production, not to have reams of documentation written about it and then spend countless hours executing those documents. We use an efficient systematic, risk based, quality system. We are experienced validation professionals.

2

Practical Compliance Information

http://www.cgmpengineering.com/eliterature.html

An efficient, systematic risk based, quality system approach to documentation enables us to prepare protocols in the shortest time possible. We employ a pragmatic approach to protocol execution allowing us to fulfill all regulatory documentation requirements quickly and efficiently. Vials and Ampoule Packaging. Looking at the customer's needs from all viewpoints: Engineering, Production, Quality, Validation, and Documentation to fully understand the expectations. Labelers, Marking and Inspection Systems.

3

Validation and Compliance Services

http://www.cgmpengineering.com/applications.html

Our competitive edge lies with the knowledge and experience of our validation personnel. This provides us with insight in the current validation needs and an intimate understanding of cGMP’s along with a keen awareness of equipment design and practical production requirements. Purified Water (USP, DI, WFI, etc.). Clean Dry Air (CDA). Nitrogen and other gas systems. Waste Water Treatment Systems. SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation.

4

What is a PQ?

http://www.cgmpengineering.com/FAQ/what-is-PQ.html

What is a PQ? SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation. Website development by Mars Media Design.

5

Confidential Validation Services

http://www.cgmpengineering.com/statement.html

Validation and Compliance Group Inc. Recognises the need of confidentiality for the purpose of doing business. Confidential information may be the source of competitive advantage and the loss of such information may have an impact on a firm’s performance. In the case of. We fully understand that confidentiality of information is the basis of trust and is the key to repeat future business. As an example, all the documents that are prepared by. To download Non disclosure Agreement (PDF).

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LINKS TO THIS WEBSITE

smbdesigngroup.com smbdesigngroup.com

Pharmaceutical - Medical Devices - Biotech

http://www.smbdesigngroup.com/projects.html

Blister Packaging Systems. [more info]. Multiple Rotary Labelers c/w Integrated Printing and Vision Inspection. Multiple Inline Labelers c/w Integrated Printing and Vision Inspection… [more info]. Multiple Large integrated Tablet filling and Packaging Lines. [more info]. Large Liquid Filling and Packaging Line. [more info]. Multiple Tablet Presses and Control Systems. [more info]. Tablet Press Preventive Maintenance Procedure Audit. [more info]. Develop and Provide cGMP Training. News, Events, Validation...

smbdesigngroup.com smbdesigngroup.com

Validation and Compliance Services

http://www.smbdesigngroup.com/applications.html

Our competitive edge lies with the knowledge and experience of our validation personnel. This provides us with insight in the current validation needs and an intimate understanding of cGMP’s along with a keen awareness of equipment design and practical production requirements. Purified Water (USP, DI, WFI, etc.). Clean Dry Air (CDA). Nitrogen and other gas systems. Waste Water Treatment Systems. SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation.

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Equipment Commissioning, Qualification and Compliance services

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

Has a extensive expertise in:. The Pharmaceutical, Medical Devices and Biotech Industries. Equipment Design and Construction. Qualification documentation and implementation. Developing Standard Operating Procedures. Development of User Requirement Specifications (URS). Detailed Design Specifications (DDS). Pharmaceutical production and packaging. Pharmaceutical production environment and physical facilities. Operator and Maintenance personnel training. Does Therein lies the competitive edge; SMB.

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Pharmaceutical Equipment Validation Services

http://www.cgmpdesign.com/services.html

We use an efficient systematic approach to protocol development which allows for the preparation of the documentation in the shortest time possible. We also employ a pragmatic, common sense, approach to protocol execution which allows us to fulfill all regulatory requirements efficiently with a minimum of delay and with a minimum of interference with operations. Auditing Services. [more info]. Quality Plans. [more info]. Validation Master Plans. [more info]. Summary Reports. [more info].

cgmpdesign.com cgmpdesign.com

Validation and Compliance Services

http://www.cgmpdesign.com/applications.html

Our competitive edge lies with the knowledge and experience of our validation personnel. This provides us with insight in the current validation needs and an intimate understanding of cGMP’s along with a keen awareness of equipment design and practical production requirements. Purified Water (USP, DI, WFI, etc.). Clean Dry Air (CDA). Nitrogen and other gas systems. Waste Water Treatment Systems. SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation.

cgmpdesign.com cgmpdesign.com

FDA Press Releases and Recalls

http://www.cgmpdesign.com/FDAfeeds.html

For the latest FDA Press Releases and Recalls, please check out the headlines below. To read the full article, simply click on the underlined text (link).

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Pharmaceutical, Biotech, Medical device Qualification services

http://www.cgmpdesign.com/markets.html

Serves two distinct customer types in three major markets: The Pharmaceutical, Medical Device and Biotechnology manufacturers or PMDB industry and the Equipment Designers and Builders that are suppliers to the PMDB industry. Additionally, training opportunities exist for those individuals who wish to enter or stay current within the PMDB industry. The primary target market encompasses all PMDB Manufacturers and their immediate subsidiaries that are subjected to FDA. The services of SMB. Training for the ...

cgmpdesign.com cgmpdesign.com

Practical Compliance Information

http://www.cgmpdesign.com/eliterature.html

An efficient, systematic risk based, quality system approach to documentation enables us to prepare protocols in the shortest time possible. We employ a pragmatic approach to protocol execution allowing us to fulfill all regulatory documentation requirements quickly and efficiently. Vials and Ampoule Packaging. Looking at the customer's needs from all viewpoints: Engineering, Production, Quality, Validation, and Documentation to fully understand the expectations. Labelers, Marking and Inspection Systems.

cgmpdesign.com cgmpdesign.com

Compliance, Validation Questions and Answers

http://www.cgmpdesign.com/faq.html

Ask us a question about equipment validation and we will endeavor to find you the answer or at least point you in the right direction for one. We appreciate any comments and tips on how to make The FAQ page a better information source. Please contact us by e-mail at Questions@SMBvalidation.com. If you find any faults, inaccurate, or otherwise unacceptable information. Who is responsible for Validation? What is an IQ? What does an IQ contain? What is an OQ? What does an OQ contain? What is a PQ? Does Part...

cgmpdesign.com cgmpdesign.com

SMB Validation and Compliance Group

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

Validation and Compliance Group Inc. Ldquo;Our ‘trademark’ is our understanding that ‘Validation is a Regulatory Requirement within a Business Environment, not a Science in itself.’ We understand that Pharmaceutical and Medical Device manufacturers purchase equipment in order to run production, not to have reams of documentation written about it and then spend countless hours executing those documents. We use an efficient systematic, risk based, quality system. We are experienced validation professionals.

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cgmpcompliance.com cgmpcompliance.com

cGMPcompliance.com - Home

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Training and Communications Group

Loading. Please wait. Call us on 6103574612. Or Create an account. Items / $0.00. And Communications Group Online Store. All prices are in All prices are in USD. Surviving a Regulatory Interview. Why Are cGMPs So Important? Material Control and Sampling. Preparing for a Regulatory Inspection. Warehouse and Distribution Control. Warehouse and Distribution Control. Surviving a Regulatory Interview. Warehouse and Distribution Control. Preparing for a Regulatory Inspection. Material Control and Sampling.

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cGMP Consulting, Inc. (current Good Manufacturing Practices)

Kevin Linde, PE. Walter C. Vincent, Jr. Track & Trace Serialization. Quality System Development and Support. Equipment / Facilities / Utilities Qualification. Process and Cleaning Validation. Ensuring your processes are compliant with. Current Good Manufacturing Practices (cGMP). FULL LIST OF SERVICES. Ensuring your processes are compliant with. Current Good Manufacturing Practices (cGMP). FULL LIST OF SERVICES. T rack and Trace / Serialization System Implementation. Process and Cleaning Validation.

cgmpdesign.com cgmpdesign.com

SMB Validation and Compliance Group

Validation and Compliance Group Inc. Ldquo;Our ‘trademark’ is our understanding that ‘Validation is a Regulatory Requirement within a Business Environment, not a Science in itself.’ We understand that Pharmaceutical and Medical Device manufacturers purchase equipment in order to run production, not to have reams of documentation written about it and then spend countless hours executing those documents. We use an efficient systematic, risk based, quality system. We are experienced validation professionals.

cgmpdoc.com cgmpdoc.com

Inicio

Asesoramiento en Sistemas de Calidad. Implementación de Procesos de Calidad. Copias Controladas y No Controladas. Asegurando la creatividad de forma continua. Consideraciones de Integridad de datos para sistemas en papel. SOPs simples y efectivos. Investigación de Causa Raíz y Sistema CAPA eficaz. KPIs y Revisión por el Management. Nuevo Servicio: Certificación ISO 9001:2015. Nuevo Taller: GMP en Mantenimiento. 2018 cGMP doc - Soluciones a medida.

cgmpengineering.com cgmpengineering.com

SMB Validation and Compliance Group

Validation and Compliance Group Inc. Ldquo;Our ‘trademark’ is our understanding that ‘Validation is a Regulatory Requirement within a Business Environment, not a Science in itself.’ We understand that Pharmaceutical and Medical Device manufacturers purchase equipment in order to run production, not to have reams of documentation written about it and then spend countless hours executing those documents. We use an efficient systematic, risk based, quality system. We are experienced validation professionals.

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