ungerconsulting.net
GMP Regulatory Intelligence - Unger ConsultingWe provide GMP Regulatory Intelligence and Enforcement Trends utilizing actual text that the regulators used in enforcement actions.
http://www.ungerconsulting.net/
We provide GMP Regulatory Intelligence and Enforcement Trends utilizing actual text that the regulators used in enforcement actions.
http://www.ungerconsulting.net/
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GMP Regulatory Intelligence - Unger Consulting | ungerconsulting.net Reviews
https://ungerconsulting.net
We provide GMP Regulatory Intelligence and Enforcement Trends utilizing actual text that the regulators used in enforcement actions.
ungerconsulting.net
Store – Unger Consulting
http://ungerconsulting.net/store
Get a Free Sample of Warning Letter Deficiencies "Data Integrity". Newly published BLOG items and updates on additions to our store. Prices are individual purchase only, please contact me. For a corporate purchase. WARNING LETTER DEFICIENCIES, DATA INTEGRITY. Seventy-seven deficiencies / comments from 49 GMP pharmaceutical warning letters issued from 1999 through 2014. 106 pages. 36;395.00 – Add to Cart. FORM 483 OBSERVATIONS, DATA INTEGRITY. Ninety observations. 78 pages. WARNING LETTER DEFICIENCIES, PR...
Barbara Unger – Unger Consulting
http://ungerconsulting.net/about
Before Amgen, I worked for the consulting firm of Don Hill and Associates providing regulatory and quality services to the pharmaceutical industry. I worked for Eli Lilly and Company in Indianapolis with positions in both the Quality unit and CMC Regulatory Affairs. I began my career in the pharmaceutical / device industry with Hybritech Inc. in San Diego, California. I received a bachelor’s degree in chemistry from the University of Illinois in Urbana Illinois. Download my resume here.
Blog – Unger Consulting
http://ungerconsulting.net/blog
Data Management Guidance from MHRA, WHO, PIC/S and China. October 31, 2016. Major regulatory authorities published guidance addressing data management and data integrity in 2015 and 2016. A previous entry addressed two of these, the draft from FDA published in April 2016 and the guidance from EMA posted in August 2016. Here we continue with the guidance from MHRA (effective version HERE and … [Read more.]. Comparison of EMA and FDA Guidance on Data Management / Data Integrity. October 27, 2016. A blog en...
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Data Integrity: The Whole Story | FDAZILLA BLOG
http://blog.fdazilla.com/2015/04/data-integrity-the-whole-story
Sign up for the FDAzilla monthly newsletter which is packed with new data insights, 483/inspection trends, and more! Also send me more information on FDAzilla's subscription services. Data Integrity: The Whole Story. Last week, Barbara Unger. Shared about the new regulatory expectations. This article uses the example of data integrity enforcement actions over the past ten-plus years and identifies the missed opportunities where firms failed to learn from publicly available information. Immediately evalua...
Form FDA 483 | FDAZILLA BLOG
http://blog.fdazilla.com/category/form-fda-483
Sign up for the FDAzilla monthly newsletter which is packed with new data insights, 483/inspection trends, and more! Also send me more information on FDAzilla's subscription services. Category Archives: Form FDA 483. What Does Getting an 483 or Warning Letter Really Cost You? 8220;Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.”. Continue reading →. This entry was posted in biopharma. CGMP Quality Assurance and FDA 483s. August 18, 2016. Benjamin Fr...
CGMP | FDAZILLA BLOG
http://blog.fdazilla.com/category/cgmp
Sign up for the FDAzilla monthly newsletter which is packed with new data insights, 483/inspection trends, and more! Also send me more information on FDAzilla's subscription services. What Does Getting an 483 or Warning Letter Really Cost You? 8220;Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.”. Continue reading →. This entry was posted in biopharma. CGMP Quality Assurance and FDA 483s. August 18, 2016. Check out the new Enforcement Analytics video.
quality assurance | FDAZILLA BLOG
http://blog.fdazilla.com/category/quality-assurance
Sign up for the FDAzilla monthly newsletter which is packed with new data insights, 483/inspection trends, and more! Also send me more information on FDAzilla's subscription services. Category Archives: quality assurance. 5 FEATURES TO LOOK FOR IN AN EIR. Continue reading →. This entry was posted in cGMP Quality Assurance and FDA 483s. August 5, 2016. Welcome to the new FDAzilla.com. That’s where we’re headed at FDAzilla. Continue reading →. This entry was posted in CGMP. July 7, 2016. June 30, 2016.
FDA Inspections | FDAZILLA BLOG
http://blog.fdazilla.com/category/fda-inspection
Sign up for the FDAzilla monthly newsletter which is packed with new data insights, 483/inspection trends, and more! Also send me more information on FDAzilla's subscription services. Category Archives: FDA Inspections. What Does Getting an 483 or Warning Letter Really Cost You? 8220;Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.”. Continue reading →. This entry was posted in biopharma. CGMP Quality Assurance and FDA 483s. August 18, 2016. Benjamin...
biopharma | FDAZILLA BLOG
http://blog.fdazilla.com/category/biopharma
Sign up for the FDAzilla monthly newsletter which is packed with new data insights, 483/inspection trends, and more! Also send me more information on FDAzilla's subscription services. What Does Getting an 483 or Warning Letter Really Cost You? 8220;Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.”. Continue reading →. This entry was posted in biopharma. CGMP Quality Assurance and FDA 483s. August 18, 2016. On Data Integrity and Compliance with CGMP.
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Marketing Design | Unger Communications
Whether you need design, copy, imaging, website creation or email marketing, brochure, catalog, logo identity, packaging or presentations. Or a mix of digital and traditional marketing deliverables, we're ready to create for you . at a moments notice. We offer a depth of experience, competitive rates, speed of service plus an upbeat, can-do attitude. Brand-building creative solutions to educate, inform, engage, interest and motivate your customers, prospects and target audience. Websites / landing pages.
Unger Construction | Home
Unger worked alongside Lionakis Architects on this design-build project in the Natomas neighborhood of Sacramento. Because the project was constructed in a designated floodplain area, the building included several unique design features to satisfy FEMA requirements. Fire Station 43 achieved LEED Silver Certification. Sutter Santa Rosa Regional Hospital. Construction of the Sutter Santa Rosa Regional Hospital is complete! CommuniCare Health Centers Peterson Clinic. Placer County Animal Shelter Facility.
Business-Class Web Hosting by (mt) Media Temple
Mt) Media Temple,Inc. - Web Hosting Built to Scale. This page has been generated automatically. If you are the server administrator and you feel that you have reached this page in error, then try completing the following steps. Please consult the (mt) Wiki. Articles below for more information. 1 Log in to Plesk ». 2 Make sure domain is added ». 3 Make sure hosting is configured ». View all related articles ». 24-7 Global Support - 877-578-4000. 1998-2008 (mt) Media Temple, Inc. Legal.
Business-Class Web Hosting by (mt) Media Temple
Mt) Media Temple,Inc. - Web Hosting Built to Scale. This page has been generated automatically. If you are the server administrator and you feel that you have reached this page in error, then try completing the following steps. Please consult the (mt) Wiki. Articles below for more information. 1 Log in to Plesk ». 2 Make sure domain is added ». 3 Make sure hosting is configured ». View all related articles ». 24-7 Global Support - 877-578-4000. 1998-2008 (mt) Media Temple, Inc. Legal.
Dipl.-Ing. Clemens Unger, Sachverständiger
Uuml;berprüfung von statischen Berechnungen. Uuml;berprüfung der Bauausführung. Begutachtung von Schäden und Mängel im Beton- und Mauerwerksbau. Dipl-Ing. Clemens Unger ist gerichtlich beeideter Sachverständiger. Beratung und Vertretung des Bauherrn. Wenn sie bei ihrem Bauvorhaben rechtzeitig einen Sachverständigen zu Rate ziehen, dann hat das für sie folg. Vorteile:. Durch die fachgerechte Beauftragung und Abrechnung von Professionistenleistungen sparen sie Geld und Ärger.
GMP Regulatory Intelligence - Unger Consulting
We Provide GMP Regulatory Intelligence and Enforcement Trends. Get a Free Sample of Warning Letter Deficiencies "Data Integrity". Newly published BLOG items and updates on additions to our store. How We Can Help You. Have you ever been asked show it to me in writing. Where the FDA says I need to do this? Are you the new process owner for a Quality System component. And wondering what FDA is citing in your area? Preparing to conduct or be the recipient of a corporate audit? Preparing for an FDA inspection?
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Ungercorp.com
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Unger Corporation
Unger Corporation - Designing and building elegant and sustainable homes in New Mexico. NM License # 54710.
Counseling & Psychotherapy Services
Counseling and Psychotherapy Services. Debra S. Unger, LCSW, ACSW. Students · Adults · Couples. Weekday, evening, and Skype sessions available. Conveniently located in Bloomington. Now accepting credit cards. Non-Discriminatory Policy: I do not discriminate based on. Race, gender, religion, or sexual orientation. Phone, text or email. Depression, Anxiety and OCD. Reproduction and Infertility Counseling. Career Planning and Professional Development. Co-Parenting and Blended Families.
Counseling & Psychotherapy Services
Counseling and Psychotherapy Services. Debra S. Unger, LCSW, ACSW. Students · Adults · Couples. Weekday, evening, and Skype sessions available. Conveniently located in Bloomington. Now accepting credit cards. Non-Discriminatory Policy: I do not discriminate based on. Race, gender, religion, or sexual orientation. Phone, text or email. Depression, Anxiety and OCD. Reproduction and Infertility Counseling. Career Planning and Professional Development. Co-Parenting and Blended Families.
