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Validation and Compliance for FDA and Other Agencies

71 New Usersclub Additions. April 10, 2017. Online Audio Seminars come with 10 Best Practice guides for easy implementation. Quality by Design (QbD) for Development and Validation of Analytical Methods. With focus on the analytical lifecycle. Recorded, available at any time. FDA Compliant IT Infrastructure and Network Qualification. With Strategies and Tool Kit for Compliance and System Uptime. Recorded, available at any time. Ensuring Data Integrity for FDA/EU Compliance. Recorded, available at any time.

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Validation and Compliance for FDA and Other Agencies | labcompliance.com Reviews

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71 New Usersclub Additions. April 10, 2017. Online Audio Seminars come with 10 Best Practice guides for easy implementation. Quality by Design (QbD) for Development and Validation of Analytical Methods. With focus on the analytical lifecycle. Recorded, available at any time. FDA Compliant IT Infrastructure and Network Qualification. With Strategies and Tool Kit for Compliance and System Uptime. Recorded, available at any time. Ensuring Data Integrity for FDA/EU Compliance. Recorded, available at any time.

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Validation and Compliance for FDA and Other Agencies | labcompliance.com Reviews

https://labcompliance.com

71 New Usersclub Additions. April 10, 2017. Online Audio Seminars come with 10 Best Practice guides for easy implementation. Quality by Design (QbD) for Development and Validation of Analytical Methods. With focus on the analytical lifecycle. Recorded, available at any time. FDA Compliant IT Infrastructure and Network Qualification. With Strategies and Tool Kit for Compliance and System Uptime. Recorded, available at any time. Ensuring Data Integrity for FDA/EU Compliance. Recorded, available at any time.

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labcompliance.com

1

Labcompliance Overview

http://labcompliance.com/misc/about/default.aspx?sm=f_d

Labcompliance is a private organization that provides the regulated Bio/Pharmaceutical industry with information on how to improve quality and to comply with FDA and other regulations and with quality standards such as ISO/IEC 17025. Starting from serving laboratories in 1999 the scope has been expanded to other areas like manufacturing and office applications. Information is provided through. Interactive on-line audio seminars with extensive hand-outs to provide information and tools for specific topics.

2

Labcompliance Tax/Bank Information

http://labcompliance.com/misc/about/tax_bank.aspx?sm=f_c

Tax and Bank Information. Company name and mail address. Att to: Christoph Huber. Tel: 49 7802 980582. Fax: 49 7802 981948. Bank Name: Sparkasse Offenburg. Beneficiary name: Christoph Huber. Bertha von Suttmer Str 8. Bank Phone: 497802 200 0. For payments in EURO. Account. No. 891251. For payments from Germany: National Bank Code/Routing Number 66450050. For payments from Europe: IBAN/Int.Bank acc. No. DE35664500500000891251. For international payments: BIC/SWIFT code: SOLADES1OFG. For Payments in US$.

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Presentations with Dr. Ludwig Huber, Labcompliance

http://labcompliance.com/misc/about/author/lh-presentations.aspx

Ludwig Hubers Presentations on Validation and Compliance. This site lists presentations developed and delivered by Dr. Ludwig Huber. Other training material from Ludwig Huber. July 7, 2016. Understanding the Final FDA Guidance for Validation of Analytical Methods. With 10 best practice guides for easy implementation. One hour Labcompliance Audio Seminar. Learn at your desk or with your colleagues in your seminar room. June 30, 2016. FDA Compliant IT Infrastructure and Network Qualification. Juni 23, 2016.

4

Publications by Dr. Ludwig Huber, Labcompliance

http://labcompliance.com/misc/about/author/lh-publications.aspx

Dr Ludwig Hubers Publications on Validation and Compliance. This site lists publications authored or co-authored by Dr. Ludwig Huber. They include text books, on-line tutorials, primers and journal publications. Publications listed here without a name are solely authored by Ludwig Huber. If there are co-authors they are named with the publications. Other training material from Ludwig Huber. Presentations, seminars, workshops. Validation of Computerized Analytical Systems. Hewlett-Packard, 1993, 152 pages.

5

Usersclub

http://labcompliance.com/usersclub/preview/fda_483.aspx

All seminars come with 10 best practice documents, such as SOPs, checklists, master plans. Learning from Recent Warning Letters Related to GMP Laboratory Controls. Or Preparation of FDA and International GMP Laboratory Inspections. Recorded, available at any time. Learning from Recent Warning Letters and 483s Related to Computer Validation and Part 11. With Case Studies to Avoid and Respond to 483s and Warning Letters. Learning from Recent Warning Letters Related to Good Laboratory Practices. For legally...

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Farmoquing Ltda - Links

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Esta página forma una comunidad farmacéutica en inglés, se encuentran artículos técnicos, proveedores de equipos, noticias del mundo farmacéutico internacional y otros apartados. PharmQuest es el sitio donde puedes encontrar información para el desarrollo de medicamentos basado en Internet, gracias a que es el pionero en esta área, proporciona herramientas habilitadas para la web y soluciones software. El Institute of Validation Technology (IVT) es el que hace las revistas Journal of Validation Technolog...

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Farmoquing Ltda - Links

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Esta página forma una comunidad farmacéutica en inglés, se encuentran artículos técnicos, proveedores de equipos, noticias del mundo farmacéutico internacional y otros apartados. PharmQuest es el sitio donde puedes encontrar información para el desarrollo de medicamentos basado en Internet, gracias a que es el pionero en esta área, proporciona herramientas habilitadas para la web y soluciones software. El Institute of Validation Technology (IVT) es el que hace las revistas Journal of Validation Technolog...

kaufmanflynn.com

资料分享

http://www.kaufmanflynn.com/zhuxie/ziliaofenxiang.html

EXPERIENCED AND SUCCESSFUL IN CGMP COMPLIANCE. Kaufman Flynn Consulting Services, LLC. Kaufman Flynn Consulting Services成员撰写的文章. Kaufman Flynn Consulting Services提供的SOP模板. Food, Drug and Cosmetic Act. FDA ORA Electronic Reading Room (483等). International Conference on Harmonization (ICH). International Society of Pharmaceutical Engineering (ISPE). International Pharmaceutical Excipients Council (IPEC).

mariahuber.de

Update on FDA and International GxP Compliance 2012

http://mariahuber.de/news/2015/07-jul_news.aspx

Version 4 just released. With strategies and tools for fast, cost-effective Laboratory Accreditation. With Quality Manual and SOPs for easy implementation. 71 New Usersclub Additions. December 1, 2014. Online Audio Seminars come with 10 Best Practice guides for easy implementation. Understanding the Final FDA Guidance for Validation of Analytical Methods. With 10 best practice guides for easy implementation. Recorded, available at any time. Analytical Instrument Qualification According the new Revision of.

mariahuber.de

Validation of Computer Systems - Training and Tools for Implementation

http://mariahuber.de/books/computers/default.aspx

All documents as shown here are included in the package, and many more! A total of 22 SOPs are included in the package. 15 of them are shown here. 9 Forms are included in the package. They help to make computer system validation consistent and effective. Cost Effective Validation of Computer Systems. Computer System Validation Package. Do it right the first time. Two audio seminars and free on-line updates. Now with two Options for Ordering. This package helps you to. Develop a strategy and master plans.

prodiance.wordpress.com

Addressing Compliance Controls for Solvency II Models | EndUserComputing.org

https://prodiance.wordpress.com/2011/03/09/addressing-compliance-controls-for-solvency-ii-models

The Ultimate Resource for Spreadsheet and EUC Risk. Spreadsheet and UDA Control: 5 Do’s and Don’ts for Success in 2011. PwC Promotes Spreadsheet Integrity Review. Addressing Compliance Controls for Solvency II Models. March 9, 2011. Tags: Basel III and spreadsheets. Solvency II and spreadsheets. In a recent article published in Life and Pension Risk Magazine entitled. Solvency II: Compliance Control. 8211; Michael Hoye, Senior Director of Enterprise Risk Services, Prodiance Corporation. You are commentin...

prodiance.wordpress.com

Spreadsheet and UDA Control: 5 Do’s and Don’ts for Success in 2011 | EndUserComputing.org

https://prodiance.wordpress.com/2011/01/11/spreadsheet-and-uda-control-10-dos-and-donts

The Ultimate Resource for Spreadsheet and EUC Risk. Basel III and Spreadsheets – The Perfect Storm? Addressing Compliance Controls for Solvency II Models. Spreadsheet and UDA Control: 5 Do’s and Don’ts for Success in 2011. January 11, 2011. In September 2010, Prodiance. Top 5 Do’s for Successful UDA Management. Organize a UDA Steering Committee. 2 Create a UDA Control Policy. I wrote about this in detail in a previous post. 3 Develop a UDA Operating Model. 4 Leverage Technology for Sustainable Controls.

galp.at

GALP :: Laboranalysen und -praxis

http://www.galp.at/links.php?kat=1

QM in medizinischen Laboratorien. QM in der Medizin. Die Adresse für den Analytiker. Http:/ www.analytik.de/. Http:/ www.vdgh.de. Informationen für den Praktiker. Http:/ www.labcompliance.com. Http:/ www.westgard.com. International Quality Assessment Schemes for Clinical Laboratories. Http:/ www.labquality.fi. Http:/ www.dgkc-online.de. Http:/ www.uni-duesseldorf.de/WWW/INSTAND/instand.htm. United Kingdom National External Quality Assessment Schemes. Http:/ www.ukneqas.org.uk/. Http:/ www.clsi.org. A par...

gxpcompliance.co.uk

GxP Compliance Ltd :: Links

http://gxpcompliance.co.uk/links

44 (0) 7092 096286. Medicines and Healthcare products Regulatory Agency (UK). Food and Drug Administration (US). International Organisation for Standardisation. The European Agency for the Evaluation of Medicinal Products. The British Standards Institution. The Medical Devices Agency. InPharm website - News, views, jobs, directories of agencies, professional organisations and freelancers. The Home Page of the Pharmaceutical Quality Group. 21 CFR Part 11.com. Good Automated Manufacturing Practice.

kaufmanflynn.com

References

http://www.kaufmanflynn.com/home/references.html

EXPERIENCED AND SUCCESSFUL IN CGMP COMPLIANCE. Kaufman Flynn Consulting Services, LLC. Papers written by members of Kaufman Flynn Consulting Services. Click following links to download in Chinese). Comparison and Research of Drug GMP in China and US. Pharmaceutical and Engineering Design. 2007, 6 (28). Organization of URS, IQ, OQ and PQ of Pharmaceutical Equipment. Pharmaceutical and Engineering Design. 2008, 3 (29). Record Management in GMP Practice. Pharmaceutical and Engineering Design. 2012, 3 (33).

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A discussion with prof. Zhou at Dameisha beach, Shenzhen. There is an annual reading party in our lab, every after one month. In the first time, we choose. Complexity A Guided Tour, Burst,. As our reading material. Our lab lies in UESTC, which has a fabulous campus in Chengdu, Sichuan. The photo is about our group chat. 01 July 2015] Lab members had a farewell banquet for guys who graduate in July 2015. 14 May 2015] Monthly seminar held for May 2015. 04 Apr 2015] 社会*心理*数据论坛.

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labcompliance.com

Validation and Compliance for FDA and Other Agencies

71 New Usersclub Additions. April 10, 2017. Online Audio Seminars come with 10 Best Practice guides for easy implementation. Quality by Design (QbD) for Development and Validation of Analytical Methods. With focus on the analytical lifecycle. Recorded, available at any time. FDA Compliant IT Infrastructure and Network Qualification. With Strategies and Tool Kit for Compliance and System Uptime. Recorded, available at any time. Ensuring Data Integrity for FDA/EU Compliance. Recorded, available at any time.

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I skate to where the puck is going to be, not where has been". Laboratorio Comunicazione è un agenzia di comunicazione dotata di un background giornalistico molto spiccato, in quanto è proprio dal mondo della stampa che arrivano le risorse presenti in azienda. La “passione per la comunicazione” è il denominatore comune che unisce gli elementi che lavorano in agenzia. Esperienza, passione e metodo sono i punti di forza di LabCom. RELAZIONI PUBBLICHE MA NON SOLO. Vedi tutte le Case Histories. Tra i maestos...

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