Übersicht der SEO Analyse
Metaangaben
67% 
Seitenqualität
16% 
Seitenstruktur
58% 
Verlinkung
3% 
Server
45% 
Externe Faktoren
30% 
SEO Score
Antwortzeit
0,08 s
Dateigröße
113,10 kB
Wörter
5446
Medien
11
Anzahl Links
455 Intern / 82 Extern

To-do Liste mit SEO Optimierungen

Meta-Angaben im HTML

Titel
(Extrem wichtig)
Validation and Compliance for FDA and Other Agencies
Die Länge des Titels ist optimal. (497 Pixel von maximal 580 Pixel Länge)
Es gibt keine Wortwiederholungen im Titel.
Meta-Description
(Extrem wichtig)
Die Meta-Description fehlt.
Crawlbarkeit
(Extrem wichtig)
Es gibt keine Probleme beim Zugriff auf die Webseite.
Canonical Link
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Es ist kein Canonical Link angegeben.
Sprache
(Wenig wichtig)
Im Text erkannte Sprache: en
Im HTTP-Equiv Element angegeben Sprache: de
Serverstandort: Deutschland
Die angegebene Sprache de stimmt nicht mit der im Text erkannten Sprache en überein.
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Es gibt keinen rel next Meta Tag auf der Seite.
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Domain
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Die Domain ist keine Subdomain.
Die Länge der Domain ist gut.
Die Domain enthält keine Umlaute.
Seiten URL
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In der URL wurden keine Parameter entdeckt.
In der URL wurde keine Session ID entdeckt.
Die URL hat nicht zu viele Unterverzeichnisse.
Zeichensatzkodierung
(Wenig wichtig)
Die Angaben zur Zeichensatzkodierung (UTF-8) sind fehlerfrei.
Doctype
(Nice to have)
Die Doctype Angabe XHTML 1.0 Transitional ist korrekt angegeben.
Die Doctype Angabe befindet sich an erster Stelle im HTML-Code.
Favicon
(Nice to have)
Es ist kein Favoriten Icon (Favicon) im HTML-Code verlinkt.

Meta Tags

NameWert
keywordsfda,gmp, glp, compliance, validation, laboratory, iso 17025
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Seitenqualität

Inhalt
(Extrem wichtig)
Der Seiteninhalt ist mit 5446 Wörtern sehr lang. Es macht eventuell Sinn den Text auf mehrere Seiten aufzuteilen.
Auf der Seite wurden Tippfehler entdeckt:
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Die durchschnittliche Satzlänge ist mit 138 Wörtern hoch.
Der Text besteht zu 21.3% aus Füllwörtern.
Worte aus dem Titel werden im Text wiederholt.
Im Text befindet sich eine Aufzählung, dies deutet auf eine gute Textstruktur hin.
Es wurden 4 Fließtextblöcke auf der Seite gefunden.
Es wurden keine Platzhalter Texte bzw. Bilder gefunden.
Es befinden sich keine Duplikate auf der Seite.
Frames
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Die Seite hat kein Frameset.
Mobile
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Es ist kein Viewport angegeben.
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Die Webseite benötigt nur wenige JavaScript Dateien (3).
Bold- und Strongtags
(Wenig wichtig)
Einige der Tags sind zu lang. Mit 76 Zeichen ist dieser länger als 70 Zeichen:
"quality by design (qbd) for development and validation of analytical methods"
Einige Tags werden wiederholt. z.B.: quality by design (qbd) for development and validation of analytical methods
Bilder Optimierung
(Wenig wichtig)
Bei 11 Bildern fehlt das Alt-Attribut. Der Inhalt von Alt-Attributen wird von Suchmaschinen auch als Text gewertet und ist wichtig für die Bildersuche.
Soziale Vernetzung
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Es befinden sich wenige Social-Sharing Möglichkeiten auf der Seite. Mit Plugins zum Teilen, kann die Reichweite der Seite in sozialen Netzwerken erhöht werden.
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(Nice to have)
Es wurde kein zusätzliches Markup gefunden.
HTTPS
(Wenig wichtig)
Das Protokoll HTTPS zur sicheren Übertragung von Daten wird nicht verwendet.

Medienliste

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Seitenstruktur

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Es befinden sich 83 Überschriften auf der Seite. Die Anzahl der Überschriften sollte in einem besseren Verhältnis zum Text stehen.
Einige Überschriften haben keinen Inhalt.

Überschriftenstruktur

Überschriften HierarchieInhalt
H1 Leere Überschrift
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Es befinden sich zu viele interne Links (455) auf der Seite.
Einige der Linktexte wiederholen sich.
6 Links haben keinen Linktext oder nur Inhalt in Alt- und Titelattributen.
Es gibt 1 Links mit einem trivialem Linktext.
Keiner der Linktexte ist zu lang.
Alle internen Links haben keine dynamischen Parameter.
Es befinden sich zu viele externe Links (82) auf der Seite.
LinkAttributeLinktext
http://www.labcompliance.com/Extern Home
http://www.labcompliance.com/m...Extern Contact Us
http://www.labcompliance.com/n...Extern Newsletter
http://www.labcompliance.com/u...Extern Usersclub
http://www.labcompliance.com/b...Extern Books
http://www.labcompliance.com/s...Extern Audio Seminars
http://www.labcompliance.com/s...Extern Textduplikat Audio Seminars
http://www.labcompliance.com/s...Extern Video Seminars
http://www.labcompliance.com/s...Extern Workshops
http://www.labcompliance.com/b...Extern Textduplikat Books
http://www.labcompliance.com/s...Extern SOPs
http://www.labcompliance.com/s...Extern Validation Examples
http://www.labcompliance.com/s...Extern Free Literature
http://www.labcompliance.com/m...Extern Glossary
http://www.labcompliance.com/u...Extern Intro
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https://www.labcompliance.com/...Extern Register
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http://www.labcompliance.com/t...Extern Risk Management Practices
http://www.labcompliance.com/t...Extern Computer Validation
http://www.labcompliance.com/t...Extern Part11
http://www.labcompliance.com/t...Extern Method Validation
http://www.labcompliance.com/t...Extern ISO 17025
http://www.labcompliance.com/t...Extern Lab Equipment Qualification
http://www.labcompliance.com/t...Extern Good Laboratory Practices
http://www.labcompliance.com/m...Extern About Labcompliance
http://www.labcompliance.com/m...Extern Contact Labcompliance
http://www.labcompliance.com/m...Extern Scope
http://www.labcompliance.com/m...Extern Tax/Bank Information
http://www.labcompliance.com/s...Extern Trivialer Linktext
click here
http://www.labcompliance.com/b...Extern Kein Text
/usersclub/default.aspx71 New Usersclub Additions
http://www.labcompliance.com/s...Extern Kein Text
http://www.labcompliance.com/s...Extern Understanding the Final FDA Guidance for Validation of Analytical Method
http://www.labcompliance.com/s...Extern FDA Compliant IT Infrastructure and Network Qualification
http://www.labcompliance.com/s...Extern Understanding the New FDA Data Integrity Guidance
http://www.labcompliance.com/s...Extern Understanding the new Revision of USP <1058>
http://www.labcompliance.com/s...Extern Integrity of Laboratory Data for FDA/EU compliance
http://www.labcompliance.com/s...Extern Quality by Design (QbD) for Development and Validation of Analytical Methods
http://www.labcompliance.com/s...Extern Ensuring Data Integrity for FDA/EU Complianc
http://www.labcompliance.com/s...Extern Learning from Recent Warning Letters related to Part 11 and Computer Validation
http://www.labcompliance.com/s...Extern Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines
http://www.labcompliance.com/s...Extern Understanding the Final FDA Guidance for Validation of Analytical Methods
http://www.labcompliance.com/s...Extern Analytical Instrument Qualification According the new Revision of USP <1058>
http://www.labcompliance.com/s...Extern FDA's New Enforcement of Part 11
http://www.labcompliance.com/s...Extern Qualification of Virtual Networks and Cloud Computing
http://www.labcompliance.com/s...Extern Textduplikat Analytical Instrument Qualification According the new Revision of USP <1058>
http://www.labcompliance.com/s...Extern Ensuring Data Integrity for FDA/EU Compliance
http://www.labcompliance.com/s...Extern Textduplikat Quality by Design (QbD) for Development and Validation of Analytical Methods
http://www.labcompliance.com/s...Extern Managing Electronic Raw Data in Regulated Environments
http://www.labcompliance.com/s...Extern FDA/EU Compliant Handling of OOX Test Results
http://www.labcompliance.com/s...Extern Managing Out of Trend Results in Pharmaceutical Quality Control
http://www.labcompliance.com/s...Extern Validation and Control of Excel Spreadsheets for FDA Compliance
http://www.labcompliance.com/s...Extern Comparing GLP with GMP
http://www.labcompliance.com/s...Extern Impact of Quality by Design on the Analytical Laboratory
http://www.labcompliance.com/s...Extern Validation and Use of Cloud Computing in FDA Regulated Environments
http://www.labcompliance.com/s...Extern Understanding Quality by Design for the Pharmaceutical Industry
http://www.labcompliance.com/s...Extern Validation of Analytical Methods according to the New FDA Guidance
http://www.labcompliance.com/s...Extern Understanding FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
http://www.labcompliance.com/s...Extern Transfer of Analytical Methods According to the New USP Chapter 1224
http://www.labcompliance.com/s...Extern FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
http://www.labcompliance.com/s...Extern System Suitability Testing for FDA and USP Compliance
http://www.labcompliance.com/s...Extern Analytical Equipment Qualification and System Validation for FDA Compliance
http://www.labcompliance.com/s...Extern Textduplikat Managing Electronic Raw Data in Regulated Environments
http://www.labcompliance.com/s...Extern FDA Compliant Use of (Certified) Reference Material
http://www.labcompliance.com/s...Extern Regulatory Aspects of 'Biosimilar' Drugs
http://www.labcompliance.com/s...Extern Understanding and Implementing the New EU-PIC/S Annex 11
/seminars/audio/298/default.aspxLaboratory Equipment Qualification according to USP <1058>
http://www.labcompliance.com/s...Extern Qualification and Use of Virtual Networks in Regulated Environments
http://www.labcompliance.com/s...Extern How to Prepare Yourself for FDA's on-going Part 11 Inspection Program
http://www.labcompliance.com/s...Extern Learning from Recent Warning Letters Related to GMP Laboratory Controls
/books/lab-compliance/default....Kein Text
/books/iso17025/default.aspxKein Text
/books/computers/default.aspxKein Text
/books/part11/default.aspxKein Text
/books/macros/default.aspxKein Text
http://www.fdawarningletter.com/Extern Kein Text
http://www.fdawarningletter.com/Extern www.fdawarningletter.com
http://www.labcompliance.com/n...Extern Kein Text
/news/2016/09-sep_news.aspxTen New in-Person Seminars with Dr. Ludwig Huber
/news/2016/09-sep_news.aspx62 New Documents added to the Labcompliance Usersclub
/news/2016/08-aug_news.aspxEMA answers Data Integrity related Frequently Asked Questions
/news/2016/07-jul_news.aspxNew FDA Guidance for Elemental Impurities in Drug Products
/news/2016/06-jun_news.aspxIT Infrastructure Qualification vs. Validation of Networked Systems
/news/2016/06-jun_news.aspxA year ago: FDA released the New Guidance on "Analytical Method Validation"
/news/2016/06-jun_news.aspxFDA's Concern about Using Actual Samples for System Evaluation Testing
/news/2016/06-jun_news.aspxFailure to Maintain Complete Data Cited In an FDA Warning Letter
/news/2016/05-may_news.aspxRecord Attendance at the New Computer Validation and Part 11 Seminar
/news/2016/05-may_news.aspxFDA expects Interim Compliance Solutions during Part 11 Upgrades
/news/2016/05-may_news.aspxUSP Publishes a Second New Revision of Chapter <1058>
/news/2016/05-may_news.aspxHong Kong SAR / PPBHK and Croatia / HALMED accede to PIC/S
/news/2016/05-may_news.aspxUSP Revises Chapter <232> on Limits of Elemental Impurities
/news/2016/04-apr_news.aspxFDA has published the Draft Guidance: Data Integrity and Compliance With CGMP
/news/2016/04-apr_news.aspx"Training Material not available in local Language" and "Data Integrity lapses draw an FDA Warning Letter
/news/2016/04-apr_news.aspxFDA Releases Draft Guidance for Industry: “Labeling for Biosimilar Products
/news/2016/04-apr_news.aspx"Failure to maintain, repair and clean Buildings" and data integrity issues cited in an FDA Warning Letter"
/news/2016/04-apr_news.aspxNew Ph. Eur. General Chapter on Chemometrics now available
/news/2016/03-mar_news.aspxGeneral Chapter Update: <197> Spectroscopic Identification Tests
/news/2016/02-feb_news.aspxFDA Releases Online Continuing Education Course on Biosimilars
/news/2016/02-feb_news.aspxTen New Class-Room Trainings with Dr. Ludwig Huber in Boston, Zurich, San Francisco, Mumbai, and Singapore
http://www.ludwig-huber.com/qu...Extern Textduplikat Trivialer Linktext
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http://www.labcompliance.com/l...Extern Textduplikat Trivialer Linktext
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/news/2016/01-jan_news.aspxNew FDA Guidance for Communication Between IND Sponsors and FDA During Drug Development
/news/2016/01-jan_news.aspxMore FDA Warning Letters with Data Integrity Issues
/news/2016/01-jan_news.aspxFDA released the final Guidance on Formal Meetings with Biosimilar Product Sponsors
/news/2016/01-jan_news.aspxPIC/S Answers Frequently Asked Questions
/news/2016/01-jan_news.aspxSeven New Class-Room Trainings with Dr. Ludwig Huber in Zurich, San Francisco, Mumbai, Hong Kong and Sydney
/news/2015/12-dec_news.aspxFree Presentation on Hot Topics at IVTs Computer and Software Validation Conference
/news/2015/11-nov_news.aspxTraining Materlal not available in local Language, cited in FDA Warning Letter
/news/2015/11-nov_news.aspxNew Version 4.0 of the ISO 17025 Accreditation Package Released
/news/2015/11-nov_news.aspxICH develops Training Material for ICH Q3D
/news/2015/11-nov_news.aspxPart 11 requires Recording and Maintaining "Complete" Records
/news/2015/11-nov_news.aspxFour New Class-Room Trainings with Dr. Ludwig Huber in Zurich and San Francisco
/news/2015/10-oct_news.aspxComputer Validation and Part 11 Cited in recent FDA Warning Letters
/news/2015/10-oct_news.aspxICH answers Frequently asked Questions related to ICH Q7
/news/2015/10-oct_news.aspxUpdated Primer: Compliance for Biopharmaceutical Laboratories
/news/2015/10-oct_news.aspxICH publishes Maintenance Procedures for ICH Q3C Impurities: Volatile Impurities
/news/2015/10-oct_news.aspxEC publishes a new Revision of Annex 16 on the Qualified Person
/news/2015/09-sep_news.aspxNew Article about the updated USP Chapter <1223>: Validation of Alternative Microbiological Methods
/news/2015/09-sep_news.aspxPIC/S GMP Annex 15 "Validation and Qualification" Effective on October 1
/news/2015/09-sep_news.aspxWhy are there so many new Guidelines on Transfer of Analytical Methods?
/news/2015/09-sep_news.aspxNew article on GMP Supervision and Inspection of Manufacturers for Medicines in the EU Market
/news/2015/09-sep_news.aspxICH Q3D on Elemental Impurities published as FDA Guidance
/news/2015/08-aug_news.aspxHealth Canada reminds drug manufacturers about the importance of data Integrity
/news/2015/08-aug_news.aspxNew FDA Guidance for Demonstrating Biosimilarity to a Reference Product
/news/2015/08-aug_news.aspx300 GxP Warning Letters on the Labcompliance Users Club Website
/news/2015/08-aug_news.aspxNew FDA Warning Letters with Data Integrity Issues
/news/2015/08-aug_news.aspxNEW FDA Guidance on Risk Evaluation and Mitigation Strategies: Modifications and Revisions
/news/2015/07-jul_news.aspxUSP Publishes New Revision of Chapter <1058>
/news/2015/07-jul_news.aspxFDA releases New Guidance on "Analytical Method Validation"
/news/2015/07-jul_news.aspxThe FDA has released its Draft Guidance on Quality Metrics
/news/2015/07-jul_news.aspxVideoclips on Part 11 Basics
/news/2015/07-jul_news.aspxFDA Answers Questions related to Residual Solvents in Drugs
/news/2015/06-jun_news.aspxCH develops Training Material for ICH Q3D
/news/2015/06-jun_news.aspxTextduplikat New Version 4.0 of the ISO 17025 Accreditation Package Released
/news/2015/06-jun_news.aspxUSP proposes Chapter <1210>: Statistical Tools for Procedure Validation
/news/2015/06-jun_news.aspxNew Guidance from OECD on Using Computers for GLP Studies
/news/2015/05-may_news.aspxPIC/S adopts the New EU GMP Annex 15: Validation and Qualification
/news/2015/05-may_news.aspxEU Issues Final Guidance for Excipient GMPs
/news/2015/05-may_news.aspxNew Date for USP Chapters 232 and 2232
/news/2015/05-may_news.aspxData Integrity in Analytical Laboratories has a long History
/news/2015/05-may_news.aspxNew Primer on FDA Inspections and Warning Letters
/news/2015/04-apr_news.aspxHighest FDA Concern: Missing availability and control of raw data
/news/2015/04-apr_news.aspxEU releases the new final version of the GMP Annex 15: Qualification and Validation
/news/2015/04-apr_news.aspxFDA releases a New Guidance on Near Infrared Analytical Procedures
/news/2015/04-apr_news.aspxFDA Warning Letter Requests Failure Investigations for a-typical Results
/news/2015/04-apr_news.aspxFDA approves first biosimilar product Zarxio
/news/2015/04-apr_news.aspxHealth Canada follows USFDA with focusing on data integrity
/news/2015/03_mar_news.aspxLabcompliance offers more in-Person Workshops
/news/2015/03_mar_news.aspxNew Article on the Development and Analysis of Biosimilars
/news/2015/03_mar_news.aspxUpdates on Using Cloud Computing in Regulated Environments
/news/2015/03_mar_news.aspxFDA Collects Information on Record Keeping Requirements for Finished Drugs
/news/2015/03_mar_news.aspxFDA added more Data Integrity Questions to the cGMP Q&A Webpage
/news/2015/03_mar_news.aspxFDA publishes Guidance Agenda for 2015
/news/2015/03_mar_news.aspxFDA mandates SOPs for Management of Out-of-Trend (OOT) and other Atypical Results
/news/2015/02_feb_news.aspxTextduplikat New Primer on FDA Inspections and Warning Letters
/news/2015/02_feb_news.aspxFDA publishes new Guidance on Current GMP Requirements for Combination Products
/news/2015/02_feb_news.aspxManual Reintegration must follow a documented Procedure", FDA says
/news/2015/02_feb_news.aspxFDA offers New Guidance Document Search Feature
/news/2015/02_feb_news.aspxNew FDA Guidance on Providing Regulatory Submissions in Electronic Format-Standardized Study Data
/news/2015/01_jan_news.aspxTextduplikat New Date for USP Chapters 232 and 2232
/news/2015/01_jan_news.aspxPIC/S establishes formal Program to Harmonize Global GMP Training
/news/2015/01_jan_news.aspxNew FDA Guidance on Delaying or Refusing a Drug Inspection
/news/2015/01_jan_news.aspxTextduplikat Data Integrity in Analytical Laboratories has a long History
/news/2015/01_jan_news.aspxCroatia and Brazil apply for PIC/S membership
/news/2015/01_jan_news.aspxThe European Medicines Agency pro-actively publishes Clinical Data
/news/2015/01_jan_news.aspx71 New Documents added to the Labcompliance Usersclub
/news/2014/12_dec_news.aspxThe EC published three updated EU GMP Chapters
/news/2014/12_dec_news.aspxTextduplikat ICH develops Training Material for ICH Q3D
/news/2012/05_may_news.aspxTextduplikat New Version 4.0 of the ISO 17025 Accreditation Package Released
/news/2014/12_dec_news.aspxPDA published Definitions for four key Quality Metrics
/news/2014/12_dec_news.aspxTextduplikat USP proposes Chapter <1210>: Statistical Tools for Procedure Validation
/news/2014/11_nov_news.aspxEU/PICS GMP Annex 11: The new global Standard for Computer Management and Validation
/news/2014/11_nov_news.aspxUSP proposes updating the weighing chapter <1251>
/news/2014/11_nov_news.aspx10 New SOPs Available since November 20
/news/2014/11_nov_news.aspxCHMP publishes a Guideline on similar biological Medicinal Products
/news/2014/11_nov_news.aspxMissing HPLC Detector Noise/drift Tests Cited in FDA Warning Letter
/news/2014/10_oct_news.aspxTextduplikat New Guidance from OECD on Using Computers for GLP Studies
/news/2014/10_oct_news.aspxUSP Publishes a Revision of the general chapter "Validation of Alternative Microbiological Methods"
/news/2014/10_oct_news.aspxFDA and EMA require an SOP for Management of Out-of-Trend (OOT) Situations
/news/2014/10_oct_news.aspxWhich SOPs are Required by GMP?
/news/2014/10_oct_news.aspx"Chromatographic Reintegration must follow an SOP", FDA Says
/news/2014/09_sep_news.aspxFDA publishes Purple Book with Lists of Licensed Biological Products
/news/2014/09_sep_news.aspxRegular Revalidation or Review of Analytical Methods: Evaluation of Efficiency and Costs
/news/2014/09_sep_news.aspxThe ICH M7 Guideline on DNA Reactive Impurities enters the Implementation Period (Step 5)
/news/2014/09_sep_news.aspxHow to Qualify Trainers in FDA regulated Areas?
/news/2014/09_sep_news.aspxFDA releases two new Guidance Documents for ANDA Submission
/news/2014/09_sep_news.aspxMHRA publishes Guidance for Development of Software used as Medical Device
/news/2014/08_aug_news.aspxNew Article on the Importance of Quality System
/news/2014/08_aug_news.aspxFDA requires Validation of Data Integrity during Software Validation
/news/2014/08_aug_news.aspxPIC/S adopts the EU Good Distribution Practice Guide
/news/2014/08_aug_news.aspxFDA expects an SOP to manage Out-of-Trend (OOT) Situations
/news/2014/08_aug_news.aspxNew FDA Guidance on Statistical Evaluation of Stability Data for Veterinary Products
/news/2014/07_jul_news.aspxShare Price of API Manufacturer drop 13 % after FDA inspection with 483 form Observations
/news/2014/07_jul_news.aspxFDA publishes Strategic Priorities 2014-2018 for Public Comment
/news/2014/07_jul_news.aspxEU GMPs require Procedures for handling OOS and OOT Results
/news/2014/07_jul_news.aspxTwo Identical Audio Seminar Sessions targeted for different Time Zones
/news/2014/07_jul_news.aspxFDA extending Part 11 Inspections to outside Asia and finds many Violations
/news/2014/06_jun_news.aspxKorea and Japan to Join PIC/S
/news/2014/06_jun_news.aspxNew SOP and Checklist for Auditing QC Labs in Line with FDA Inspections
/news/2014/06_jun_news.aspxFDA launches "openFDA" to provide easy Access to valuable FDA public Data
/news/2014/06_jun_news.aspxInadequate Handling of OOS Test Results and Incomplete Records key Points of an FDA Warning Letter
/news/2014/06_jun_news.aspxEMA Publishes New Guidance Template for Qualified Person's
/news/2014/06_jun_news.aspxFDA publishes final Guidance on Stability Testing for Generics
/news/2014/05_may_news.aspxNew Seminar Series: Regular Compliance Updates for (Bio)Pharma
/news/2014/05_may_news.aspxExcel Spreadsheets again on Target of FDA Inspections
/news/2014/05_may_news.aspxNew FDA Guidance on Post Approval Manufacturing Changes
/news/2014/05_may_news.aspxQbD Lessons Learned from an FDA Filing
/news/2014/05_may_news.aspx'Advice' from FDA on Using Excel in Regulated Environments
/news/2014/05_may_news.aspxFDA publishes new Draft Guidance on Biosimilarity to Reference Products
/news/2014/04_apr_news.aspxNew EU GMP Annex 15 requires Factory and Site Acceptance Testing
/news/2014/04_apr_news.aspxFDA Publishes 2014 Annual Report on Inspections of Establishments
/news/2014/04_apr_news.aspxEMA Releases new Guideline on Process Validation
/news/2014/04_apr_news.aspxFDA warns Pharmaceutical Labeler Facility for incomplete API Records
/news/2014/04_apr_news.aspxFinal Version of the Chapter 6 Quality Control of the EM GMPs published
/news/2014/04_apr_news.aspxFDA expects GMP regulated Method Development Data
/news/2014/03_mar_news.aspxLab equipment failures must be investigated, FDA Warning letter says
/news/2014/03_mar_news.aspxNew revision of the EU-GMP Annex 15 on Validation and Qualification
/news/2014/03_mar_news.aspxFDA releases a New Draft Guidance on "Analytical Method Validation"
/news/2014/03_mar_news.aspxTextduplikat Updates on Using Cloud Computing in Regulated Environments
/news/2014/03_mar_news.aspx"Quality by Design" is getting more and more important for Pharma
/news/2014/02_feb_news.aspxFDA requests Operational Qualification for Analytical Laboratory Instrumentation
/news/2014/02_feb_news.aspxHealth Canada releases new GMP Guidelines for APIs
/news/2014/02_feb_news.aspxCooperation between US FDA and Indian Ministry of Health & Family Welfare for better Drug Safety
/news/2014/02_feb_news.aspxFDA releases new Guidance on "Validation of Bioanalytical Methods"
/news/2014/02_feb_news.aspxNew Part 11 Compliance Package for Trouble-free Implementation
/news/2014/01_jan_news.aspxUSP proposed to Revise the General Chapter <1092> on Dissolution
/news/2014/01_jan_news.aspxEMA Releases Inspectional Information on GMP Issues
/news/2014/01_jan_news.aspxFDA and EMA launch generic drug application inspections initiative
/news/2014/01_jan_news.aspxNew presentation on "Future Activities of ICH from the FDA Point of View"
/news/2014/01_jan_news.aspxLabcompliance Introduces the New Network Compliance Package
/news/2013/12_dec_news.aspxNew Article on Control of Elemental Impurities by the European Pharmacopeia
/news/2013/12_dec_news.aspxHong Kong SAR applied for PIC/S membership
/news/2013/12_dec_news.aspx10 New FDA Drug Inspectors Stationing in China
/news/2013/11_nov_news.aspxFDA Continues with Part 11 Inspections and related Warning Letters
/news/2013/11_nov_news.aspxFDA Releases a Draft Guidance on Elemental Impurities
/news/2013/11_nov_news.aspxFDA Request a Retrospective Review of all Drugs manufactured at a Facility after Improper Laboratory Testing
/news/2013/11_nov_news.aspxNew Article on Analysis of Biopharmaceuticals for ICH Q6B Compliance
/news/2013/10_oct_news.aspxFDA Publishes a New Draft Guidance on Bioanalytical Method Validation
/news/2013/10_oct_news.aspxMultiple Laboratory GMP Violations cited in FDA Warning Letter
/news/2013/10_oct_news.aspxFDA releases a Draft Guidance on Requirements for ANDA Submissions
/news/2013/10_oct_news.aspxUSP Proposes a Revision Plan for General Chapters on Elemental Impurities
/news/2013/10_oct_news.aspxFDA releases the final Guidance on Use of Electronic Source Data in Clinical Investigations
/news/2013/09_sep_news.aspxElemental Impurities According to the new ICH Q3D Guideline
/news/2013/09_sep_news.aspxFDA Warning for Inadequate Storage of Reference Samples and Reagents
/news/2013/09_sep_news.aspxFDA publishes Daft Guidance for Drug Establishment Registration
/news/2013/09_sep_news.aspxMore and more Organizations want to become PIC/S Members
/news/2013/09_sep_news.aspxFDA Answers Questions Related to ANDA Stability Testing for Drug Substances and Drug Products
/news/2013/09_sep_news.aspxFDA expects Supporting Data for Extension of the Expiration Date of Reference Material
/news/2013/08_aug_news.aspxFDA Releases Guidance on Quality Agreements for Contract Manufacturing
/news/2013/08_aug_news.aspxNew Stimuli Article on Method Development, Performance Qualification and Performance Verification
/news/2013/08_aug_news.aspxMissing Requalification of Analytical Equipment draws FDA Warning Letter
/news/2013/08_aug_news.aspxFDA issues Guidance for Industry on Risk-Based Monitoring
/news/2013/08_aug_news.aspxNew FDA Draft Guidance on Delaying or Refusing a Drug Inspection
/news/2013/08_aug_news.aspxLack of Reliability, Accuracy and Integrity of Electronic Raw Data a Serious Concern for the FDA
/news/2013/07_jul_news.aspxNew FDA Guidance for Stability Testing of Generic Drugs
/news/2013/07_jul_news.aspxLearning from Recent FDA GMP Warning Letters
/news/2013/07_jul_news.aspxUSA API manufacturers exempt from Individual GMP Certificates for EU Import
/news/2013/07_jul_news.aspxNew Annex 16 to EU-GMP on Certification by a Qualified Person released
/news/2013/07_jul_news.aspxFDA Warning for Insufficient Number of System Suitability Test Runs
/news/2013/07_jul_news.aspxNew FDA Draft Guidance on Cosmetic Good Manufacturing Practices
/news/2013/06_june_news.aspxHow to Qualify Manufacturers of APIs: Questions and Answers
/news/2013/06_june_news.aspxNew USP Chapters for Elemental Impurities Deferred
/news/2013/06_june_news.aspxNew FDA Guidance on Co-development of Two or More new Investigational Drugs
/news/2013/06_june_news.aspxTextduplikat FDA expects an SOP to manage Out-of-Trend (OOT) Situations
/news/2013/06_june_news.aspxJapanese API manufacturers exempt from Individual GMP Certificates for EU Import
/news/2013/05_may_news.aspxUSP Offers Free Compendium with Testing Standards for Herbal Ingredients used in Traditional Medicines
/news/2013/05_may_news.aspxAn "Outlook on U.S. Biosimilar Competition", Life Sciences Report available
/news/2013/05_may_news.aspxTextduplikat 'Advice' from FDA on Using Excel in Regulated Environments
/news/2013/05_may_news.aspxGeneric Drug Manufacturer agrees to pay M$500 Fine for GMP Violations
/news/2013/05_may_news.aspxExcipient and Pharmaceutical Manufacturers are Concerned about the USP Timeline for Chapters <232/233>
/news/2013/05_may_news.aspxLaboratory Data Integrity Issues Cited as FDA GMP Deviations
/news/2013/04_apr_news.aspxFDA Releases Draft Guidance on Setting Limits for Mutagenic Impurities
/news/2013/04_apr_news.aspxFDA Releases Final Guidance for Computer System Validation
/news/2013/04_apr_news.aspxRevised EU GMP Guide Requires formal Transfer of Analytical Methods
/news/2013/04_apr_news.aspxDetailed Comparison between EU & Indian GMP Requirements for APIs
/news/2013/04_apr_news.aspxICH Releases M7 Step 2 Guidance for Mutagenic Impurities
/news/2013/04_apr_news.aspxFDA Warning: Paper print-outs of e-records incomplete, missing e-audit trail, no back-up of raw data
/news/2013/03_mar_news.aspxFDA Answers Questions related to User Fees for Generic Drugs
/news/2013/03_mar_news.aspxNew FDA Guidance on Formal Dispute Resolution
/news/2013/03_mar_news.aspx"No Acceptance Testing during Method Transfer" cited in FDA 483
/news/2013/03_mar_news.aspxNew Global Guidelines and Regulations Impacting Validation Professionals
/news/2013/03_mar_news.aspxNew Publication on Recent Developments of Biosimilar Products
/news/2013/03_mar_news.aspxFDA 483 Observation caused by wrong SOP for Method Transfer
/news/2013/02_feb_news.aspxUSP General Notice suggest USP Reference Standards to be a MUST for USP Compendial Standards
/news/2013/02_feb_news.aspx"CGMP Regulations not included in the Training program" draws FDA Warning Letter
/news/2013/02_feb_news.aspxFDA Announces the Availability of the ICH Q11 Guidance
/news/2013/02_feb_news.aspx14 New SOPs Available since February 1.
/news/2013/02_feb_news.aspxEMA published a Concept Paper on Revision of Annex 15 of the EU GMP
/news/2013/02_feb_news.aspxFDA expects Deviations from GLP SOPs to be Authorized and Documented
/news/2013/01_jan_news.aspxFDA CDER Presents FY 2012 Review
/news/2013/01_jan_news.aspxFDA Expects Periodic Requalification of GCs and HPLCs
/news/2013/01_jan_news.aspxFDA Presentation on Quality by Design for Analytical Methods
/news/2013/01_jan_news.aspxFDA Warning Letter for Insufficient Training and inadequate Response
/news/2013/01_jan_news.aspxFDA expects Multifold Increase of Foreign Generic Drug Manufacturer Inspections
/news/2013/01_jan_news.aspxNATA Updates Technical Note for the Validation of Test Methods
/news/2012/12_dec_news.aspxNew FDA Guidance: Electronic Source Data in Clinical Investigations
/news/2012/12_dec_news.aspxTextduplikat EU/PICS GMP Annex 11: The new global Standard for Computer Management and Validation
/news/2012/12_dec_news.aspxTextduplikat How to Qualify Manufacturers of APIs: Questions and Answers
/news/2012/12_dec_news.aspxFDA understands the Industry's Need for Virtual Networks and Cloud Computing
/news/2012/12_dec_news.aspxNew ICH/FDA Guidance on Genotoxicity Testing for Pharmaceuticals
/news/2012/12_dec_news.aspxHow to Qualify IT Infrastructure?
/news/2012/11_nov_news.aspxFDA publishes ICH Guidance on Development and Manufacture of Drug Substances
/news/2012/11_nov_news.aspxUSP Postpones the official Date for Chapters <232/233>
/news/2012/11_nov_news.aspxThree easy steps towards FDA compliant Electronic Signatures
/news/2012/11_nov_news.aspxNew Zealand and Taiwan to join PIC/S
/news/2012/11_nov_news.aspxBiosimilars Handbook available from the European Generic Medicines Association
/news/2012/11_nov_news.aspxTextduplikat Updates on Using Cloud Computing in Regulated Environments
/news/2012/10_oct_news.aspxNew FDA Guidance for ANDA Stability Testing
/news/2012/10_oct_news.aspxEMA answers Questions related to Specification Limits of Genotoxic Impurities
/news/2012/10_oct_news.aspxPIC/S Adopts EU GMP Annex 11 as PIC/S Annex
/news/2012/10_oct_news.aspxLearning from Recent FDA GLP Warning Letters
/news/2012/10_oct_news.aspxJapanese Guidelines for Computerized Systems and Electronic Records&signatures available
/news/2012/10_oct_news.aspxMore EMA GMP Inspections caused by significant quality or GMP problems
/news/2012/09_sep_news.aspxNew FDA Guidance for Pyrogen and Endotoxins Testing
/news/2012/09_sep_news.aspxFDA Recommends 3rd Party Consultant for Lab Equipment Qualification
/news/2012/09_sep_news.aspxVideo on FDA Drug Development and Approval
/news/2012/09_sep_news.aspxEURACHEM Releases the 3rd Edition of the Measurement Uncertainty Guide
/news/2012/08_aug_news.aspxUSP Proposes Changing the General Chapter 'Weight and Balances'
/news/2012/08_aug_news.aspxEMA Releases Guideline on 'Real Time Release Testing'
/news/2012/08_aug_news.aspxNew Guideline on the use of Near Infrared Spectroscopy (NIRS)
/news/2012/08_aug_news.aspxISPE Releases New Guidance for 'Pharmaceutical Change Management'
/news/2012/08_aug_news.aspxFDA Warning Letter Issued for Missing Verification of Analytical Methods
/news/2012/08_aug_news.aspxFDA Video explains the 'Accelerated Approval Program'
/news/2012/07_jul_news.aspxNew FDA List with New/Revised/Withdrawn Guidances available
/news/2012/07_jul_news.aspxTextduplikat New Part 11 Compliance Package for Trouble-free Implementation
/news/2012/07_jul_news.aspxEGA Answers Questions about Biosimilar Medicines
/news/2012/07_jul_news.aspxAll Drug and API Manufacturers must Control Elemental Impurities
/news/2012/07_jul_news.aspxHalf of FY11 FDA GMP Warning Letters tied to Batch Failures
/news/2012/07_jul_news.aspxFDA Update on Ongoing-Activities and Product Recalls
/news/2012/07_jul_news.aspxMHRA answers Frequently Asked Questions related to OOS
/news/2012/06_jun_news.aspxIndonesia Joins PIC/S
/news/2012/06_jun_news.aspxLabcompliance releases new New Computer System Validation Package
/news/2012/06_jun_news.aspxFDA Presentation on International Compliance Issues
/news/2012/06_jun_news.aspxFree E-Book on Virtualization of Computer Systems and Networks
/news/2012/06_jun_news.aspxEMA Releases Draft Guideline on Similar Biological Medicinal Products
/news/2012/06_jun_news.aspxKorea applies for PIC/S membership
/news/2012/05_may_news.aspxNew Version 3.0 of the ISO 17025 Accreditation Package Released
/news/2012/05_may_news.aspxUSP Chapters <232/233> for Elemental Impurities Approved
/news/2012/05_may_news.aspxFDA Warning letter: Paper print-outs of e-records incomplete, missing e-audit trail, no back-up of raw data
/news/2012/05_may_news.aspxEMA Releases Quality Guideline Concerning Biological Investigational Medicinal Products
/news/2012/05_may_news.aspxTextduplikat 'Advice' from FDA on Using Excel in Regulated Environments
/news/2012/05_may_news.aspxJapan Applies for PIC/S Membership
/news/2012/04_apr_news.aspx"Your Response is not Adequate, Because .....": is the most frequent Warning Letter statement
/news/2012/04_apr_news.aspxPIC/S publishes Inspection Guide on Quality Risk Management Systems
/news/2012/04_apr_news.aspxNumber of FDA Warning Letters still Increasing
/news/2012/04_apr_news.aspx12 Months FDA Update Presented by FDA Officials
/news/2012/04_apr_news.aspxConsent Decree requests Drug Manufacturer hiring 3rd Party Auditors to resolve "Data integrity" Issues
/news/2012/04_apr_news.aspxEMA answers Frequently Asked Questions related to Biosimilar Products Applications
/news/2012/04_apr_news.aspx"Rationale for inspection of Reserve Samples is not based on Statistical Assessment" draws FDA 483
/news/2012/03_mar_news.aspxNew FDA Guidance on Safety Data Collection
/news/2012/03_mar_news.aspxFDA Warning Letter: Import Alert for Polish API Manufacturer
/news/2012/03_mar_news.aspxFDA CDER Launches New Web Education Series on Drug Review Process
/news/2012/03_mar_news.aspxTextduplikat FDA Continues with Part 11 Inspections and related Warning Letters
/news/2012/03_mar_news.aspxChinese Pharmacopeia 2010 Edition Available in English
/news/2012/03_mar_news.aspx"Samples not Representative" cited in FDA Warning Letter
/news/2012/03_mar_news.aspxNew FDA Guidance on Acceptance of Foreign Clinical Studies
/news/2012/02_feb_news.aspxFDA issues Draft Guidance on Biosimilar Product Development
/news/2012/02_feb_news.aspxThe USP <1224> for Method Transfer is coming in May: Are you ready?
/news/2012/02_feb_news.aspxFDA Warning Letters in 2011 Increased 155% from 2010
/news/2012/02_feb_news.aspxEMA Guideline on Quality of Herbal Medicinal Products Final
/news/2012/02_feb_news.aspxInadequate Transfer of analytical methods cited in FDA Warning Letter
/news/2012/02_feb_news.aspxEnglish Version of the New Chinese GMPs available on the WHO Website
/news/2012/01_jan_news.aspxJoint EMA and FDA Inspections starting in January
/news/2012/01_jan_news.aspxFree E-Books on Cloud Computing and Virtualization of Networks
/news/2012/01_jan_news.aspxProduct Recalls and Temporary Manufacturing Halt after FDA Inspection
/news/2012/01_jan_news.aspxFDA Publishes Updated ANDA Checklist
/news/2012/01_jan_news.aspxFDA Expects Robustness Testing during Method Validation
/news/2012/01_jan_news.aspxUSP Chapter <1224> on Transfer of Analytical Procedures official in May 2012
/news/2011/12_dec_news.aspxWHO continues to publish Inspection Report Summaries
/news/2011/12_dec_news.aspxFDA expects Global Corrective Actions for Inspectional Observations
/news/2011/12_dec_news.aspxPPD Publishes White Paper on Clinical Developments for Biosimilar Drugs
/news/2011/12_dec_news.aspxInadequate SOPs for Analytical Method Validation and Transfer cited in FDA Warning Letter
/news/2011/12_dec_news.aspxEU will require Certificates for API Imports from third Countries
/news/2011/12_dec_news.aspxFDA expects an SOPs to manage Out-of-Trend (OOT) Situations
/news/2011/11_nov_news.aspx50 New Documents in the Labcompliance Usersclub
/news/2011/11_nov_news.aspxFDA Focus on Computer Validation Ongoing
/news/2011/11_nov_news.aspxFDA Answers Questions related to ICH Q8/Q9/Q10 Implementation
/news/2011/11_nov_news.aspx"Corrective Action for inadequate Method Validation too late", FDA Warning Letter says
/news/2011/11_nov_news.aspxPIC/S Reaches Membership Milestone: 40 Members
/news/2011/11_nov_news.aspxMissing Robustness Testing for Analytical Methods cited in FDA Warning Letter
/news/2011/11_nov_news.aspxRussia to follow India and China as Pharma Drug and API Manufacturer
/news/2011/10_oct_news.aspxDevice Manufacturer Cited for not Having Supplier Quality Agreements
/news/2011/10_oct_news.aspxEMA Guideline on Bioanalytical Methods Validation Effective by Feb 1, 2012
/news/2011/10_oct_news.aspxFDA requires formal Stability Assessment of In-house Prepared Standard Solutions used for Quantitative Analysis
/news/2011/10_oct_news.aspxFDA Published FY2010 Inspectional Observation Summary
/news/2011/10_oct_news.aspxFDA Proposes Enhancing Search Criteria for Inspections Database
/news/2011/10_oct_news.aspxInadequate Response to 483 Observations Causes Part 11 Warning Letter
/news/2011/09_sep_news.aspxHealth Agency helps Industry Preparing for an Initial Drug GMP Inspection
/news/2011/09_sep_news.aspxFDA Official Reports about Part 11 Related Inspectional Observations
/news/2011/09_sep_news.aspx"Failure to Provide Adequate Study Direction", cited in FDA Observation
/news/2011/09_sep_news.aspxTextduplikat IT Infrastructure Qualification vs. Validation of Networked Systems
/news/2011/09_sep_news.aspxUSP Publishes Six New General Chapters on Spectroscopy Methods
/news/2011/09_sep_news.aspxRecent Warning Letter Related to 21 CFR Part 11
/news/2011/09_sep_news.aspxFirst US FDA India Seminar on Computer System Validation & Part 11 Compliance a big Success
/news/2011/08_aug_news.aspxExcel Spreadsheet not protected against unauthorized Use" cited in FDA 483
/news/2011/08_aug_news.aspxWHO Publishes Guidance on Technology Transfer
/news/2011/08_aug_news.aspxNew free Tutorial on Risk Management
/news/2011/08_aug_news.aspxStudies Conducted by CRO May Require Reevaluation, FDA Says
/news/2011/08_aug_news.aspxFDA Commissioner Dr. Hamburg Talked about Sharing Global Inspection Data
/news/2011/08_aug_news.aspxFDA Warning Letter Issued for Missing Verification of Compendial Methods
/news/2011/07_jul_news.aspxUSP: Current and Future Directions
/news/2011/07_jul_news.aspxFDA Update on Part 11
/news/2011/07_jul_news.aspxEU GMP Annex 11 enforced since July 1
/news/2011/07_jul_news.aspxResponse to 483 after 15 business days declined by FDA
/news/2011/07_jul_news.aspxFDA Introduces a Spectral Library to Detect Improper Ingredients in Drugs
/news/2011/07_jul_news.aspxNew Article on Quality Risk Management Principles With Case Studies
/news/2011/06_jun_news.aspxFDA Warning Letters increasing by 30% in FY 2011
/news/2011/06_jun_news.aspxPeriodic Evaluation and Review of Computer Systems Legally Required
/news/2011/06_jun_news.aspxFDA expects to Validate or Verify the Accuracy of Bioanalytical Methods
/news/2011/06_jun_news.aspxNew FDA Guidance about Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies
/news/2011/06_jun_news.aspxShares fall 5 Percent Caused by an FDA GMP Warning Letter
/news/2011/06_jun_news.aspxPart 11 Related Deviations Cited in FDA Warning Letter
/news/2011/06_jun_news.aspxFDA Publishes Names and Addresses of Inspected Facilities
/news/2011/06_jun_news.aspxApprovals for Biopharmaceuticals nearly doubled in the past Decade
/news/2011/05_may_news.aspxFDA Requests 'Global' Improvements to address Raw Data Issues
/news/2011/05_may_news.aspxEMA Answers Questions Related to the New EU Annex 11
/news/2011/05_may_news.aspxNew FDA Guidance for Submission of Summary Bioequivalence Data
/news/2011/05_may_news.aspxFDA recommends to hire a Third Party Auditor for detecting (Raw) Data Integrity Problems
/news/2011/05_may_news.aspxFree FDA Web Seminar on Foreign Inspections
/news/2011/05_may_news.aspxCan Electronic Raw Data be deleted after Printouts?
/news/2011/05_may_news.aspxUSP Updates Draft Chapters 232&233 for Analysis of Metal impurities
/news/2011/04_apr_news.aspxFDA Warning Letter Issued for Inadequate Use of Excel Spreadsheets
/news/2011/04_apr_news.aspxPIC/S Publishes Questions & Answers Document Regarding Distribution Activities for APIs
/news/2011/04_apr_news.aspxMicrosoft Offers SharePoint 2010 Configuration Guidance for Part 11 Compliance
/news/2011/04_apr_news.aspxFDA is Using Excel in its own Regulated Environments
/news/2011/04_apr_news.aspx"Raw Data for Annual Instrument Re-Qualification not Maintained" cited in Warning Letter
/news/2011/04_apr_news.aspxIs the U.S. Really Slower than Europe in Approving New Drugs?
/news/2011/04_apr_news.aspxLabcompliance Offers Workshop for Validation of Analytical Methods
/news/2011/03_mar_news.aspxFDA Starts to Look for Measurement Uncertainty
/news/2011/03_mar_news.aspxNew FDA Draft Guidance: Electronic Source Documentation in Clinical Investigations
/news/2011/03_mar_news.aspxFDA 483 for Insufficient Number of Qualified People
/news/2011/03_mar_news.aspxUSP Proposes to Update Chapter on Verification of Compendial Methods
/news/2011/03_mar_news.aspx"SOP does not Ensure Sample Integrity" cited in FDA 483
/news/2011/03_mar_news.aspxCan Vendors Offer 'FDA Compliant' or "Part 11 Compliant" Software?
/news/2011/03_mar_news.aspx73 New Documents added to the Labcompliance Usersclub
/news/2011/02_feb_news.aspxThe EU Annex 11 Can Become Important for FDA Regulated Industry
/news/2011/02_feb_news.aspxFDA Warning Letter for Inadequate Transfer of Analytical Methods
/news/2011/02_feb_news.aspxLaboratory Controls #1 Deviations in FDA GMP Inspections
/news/2011/02_feb_news.aspxInadequate Per
/news/2011/02_feb_news.aspxormanc
/news/2011/02_feb_news.aspxQualification" cited in FDA Warning Letter
/news/2011/02_feb_news.aspxUSP Publishes the New Chapter <1224> for Analytical Method Transfer
/news/2011/02_feb_news.aspxFDA Publishes the Final Version of the Process Validation Guidance
/news/2011/02_feb_news.aspxFDA Part 11 Inspections Starting with Delay
/news/2011/01_jan_news.aspxNew EU GMP Annex 11 on Computerized Systems Released
/news/2011/01_jan_news.aspxFDA Published Advance Notice of Rulemaking for GLP Revisions
/news/2011/01_jan_news.aspx"Stability Testing Co-eluting Peaks not Identified", cited in FDA Warning Letter
/news/2011/01_jan_news.aspxUSP Pharmacopeial Forum (PF) now for Free
/news/2011/01_jan_news.aspxNumber of GLP Warning Letters and Number of Deviations Increasing
/news/2010/12_dec_news.aspxFDA Releases New Guidance for ANDAs: Impurities in Drug Products
/news/2010/12_dec_news.aspxFDA Warning: Stability Indicating Methods not Selective, not Validated or not Followed
/news/2010/12_dec_news.aspxEMA Publishes Guideline on Similar Biological Medicinal Products
/news/2010/12_dec_news.aspxEMA Publishes Guidance on the Investigation of Bioequivalence
/news/2010/12_dec_news.aspxFDA Expects Forced Degradation in the Presence of all APIs, Warning Letter Says
/news/2010/12_dec_news.aspxLabcompliance ISO 17025 Tutorial Updated
/news/2010/12_dec_news.aspxOutsource Analytical QC Testing Yes or No?
/solutions/sops/default.aspxKein Text
/news/2010/11_nov_news.aspxFDA Will Join PIC/S in January 2011
/news/2010/11_nov_news.aspxFDA Warning: Computers Must be Revalidated Before Put in Operation After Changes
/news/2010/11_nov_news.aspxEMA Posted Questions & Answers about Post Approval Changes
/news/2010/11_nov_news.aspxFDA Guidance for Early Clinical Trials with Live Biotherapeutic Products
/news/2010/11_nov_news.aspxFDA Guidance on the Need of IND for Conducting Clinical Trials
/news/2010/11_nov_news.aspxFree 76-page Primer on Method Validation Available
/news/2010/10_oct_news.aspxSpreadsheets Should be Verified for Accuracy, FDA Warning Letter says
/news/2010/10_oct_news.aspxDo all EU GMP Inspections Cover the Quality Risk Management Process?
/news/2010/10_oct_news.aspxAgain and Again, Part 11 Related Deviations Cited in FDA Warning Letter
/news/2010/10_oct_news.aspxFDA Issued Final Rule on Safety Information During Clinical Trials
/news/2010/10_oct_news.aspxNew Part 11 Compliance Package Available as Download
/news/2010/10_oct_news.aspxFDA 'Advice' on Validation and Use of Excel®
/news/2010/09_sep_news.aspxFDA Publishes Guidance on Capillary Electrophoresis
/news/2010/09_sep_news.aspxFree 28-page White paper on Supply Chain Security from ISPE
/news/2010/09_sep_news.aspxFDA Warning Letter for Inadequate Validation of Analytical Methods
/news/2010/09_sep_news.aspxFDA Publishes Questions and Answers on Product Recall
/news/2010/09_sep_news.aspxFree FDA Web Seminar about Generic Drugs
/news/2010/08_aug_news.aspxFDA Inspection Clarifies what "Readily Available Documentation" Means
/news/2010/08_aug_news.aspxFDA Plans Using Internal Audit Reports for Risk Assessment
/news/2010/08_aug_news.aspxPrinted HPLC Chromatograms not Considered a 'True Copy' of e-Raw Data
/news/2010/08_aug_news.aspxNo Failure Investigations after Failed GC Calibration Cited by FDA
/news/2010/08_aug_news.aspxFDA Video Training Updated
/news/2010/08_aug_news.aspxDo You Know what FDA Does? Learn about FDA Basics from the FDA
/news/2010/08_aug_news.aspxTextduplikat FDA Warning for Insufficient Number of System Suitability Test Runs
/news/2010/07_jul_news.aspxNew FDA Draft Guidance on CMC Post-approval Changes
/news/2010/07_jul_news.aspxSpreadsheet Calculations not Verified' Cited in FDA Warning Letter
/news/2010/07_jul_news.aspxThe UK MHRA Updates Guidance for Stand Alone Contract Laboratories
/news/2010/07_jul_news.aspxFDA Announces New Inspections with Focus on Part 11
/news/2010/07_jul_news.aspxFree FDA Training on Human Drug Regulations
/news/2010/07_jul_news.aspxFDA Warning for Missing Verification of Expiration Date Calculation
/news/2010/06_jun_news.aspxEU Guidance on Classification of Medical Devices Updated
/news/2010/06_jun_news.aspxNew Spreadsheet Quality Package Available as Download
/news/2010/06_jun_news.aspxGenzyme Corp. Signs Consent Decree to Correct Manufacturing Quality Violations
/news/2010/06_jun_news.aspxPIC/S Assessment of FDA Membership Targeted for the Next Comittee Meeting
/news/2010/06_jun_news.aspxSoftware Testing Raw Data not Saved Cited in FDA Warning Letter
/news/2010/06_jun_news.aspxNew Template for Drug API Quality Agreements
/news/2010/05_may_news.aspxFDA's Updates the Preapproval Inspections/Investigations Manual
/news/2010/05_may_news.aspxFDA-483 with 11 Observations Related to QC Laboratory Controls
/news/2010/05_may_news.aspxPIC/S Publishes Example for Quality Risk Management Implementation
/news/2010/05_may_news.aspxLabcompliance Tutorial on ISO 17025 Updated
/news/2010/05_may_news.aspx3 Inspectional Observations Related to FDA's Dietary Supplement GMP's
/news/2010/05_may_news.aspxFDA Publishes Guidance for Industry: ICH Q8, Q9, and Q10 - Questions and Answers
/news/2010/05_may_news.aspxFDA Inspection Reports - Ideal Case Studies for Dietary Supplement GMPs
/news/2010/04_apr_news.aspxFDA Inspections for 21 CFR 111 (Dietary Supplements) will Become Common
/news/2010/04_apr_news.aspxPharmacopoeial Discussion Group (PDG) Recommendations for Dissolution Testing
/news/2010/04_apr_news.aspxWHO Publishes Guideline for the Production and Control of Starting Materials
/news/2010/04_apr_news.aspx51-Page FDA Inspection Report Related to Dietary Supplements
/news/2010/04_apr_news.aspxHow Much Validation is Enough?
/news/2010/04_apr_news.aspxFDA Focus on Integrity, Security and Authenticity of E-Records
/news/2010/04_apr_news.aspxVideo on Software Regulation with John Murray on FDA's Website
/news/2010/03_mar_news.aspxRevised Draft of Annex 11 to EU GMPs to be Released in the next few Weeks
/news/2010/03_mar_news.aspxFDA Inspection Focus on Security, Availability and Integrity of E-Records
/news/2010/03_mar_news.aspxFDA Releases Guidance for Product Sterilization Control
/news/2010/03_mar_news.aspxAPIC Publishes Guidelines and Two Templates for Quality Agreements
/news/2010/03_mar_news.aspxLabcompliance Usersclub gets more attractive with new Document Category
/news/2010/03_mar_news.aspx"Stability Chambers not Re-qualified" Cited in Recent FDA 483
/news/2010/03_mar_news.aspxNew Supply Chain Guidance from TGA
/news/2010/02_feb_news.aspxFDA Launches a new Risk-Assessment Tool for Better Drug and Food Import Control
/news/2010/02_feb_news.aspxICP Systems for Metal Impurity Analysis Must be Part 11 Compliant
/news/2010/02_feb_news.aspxUSP Changes Dissolution Performance Verification Tests
/news/2010/02_feb_news.aspxOOS of Stability Chambers not Investigated" Draws FDA Warning Letter
/news/2010/02_feb_news.aspxFDA Publishes New Guidance for Calibration of Dissolution Apparatus
/news/2010/02_feb_news.aspxFDA Warning for Data Manipulation
/news/2010/01_jan_news.aspxA Vendor's Statement is not Enough Evidence for Software Validation
/news/2010/01_jan_news.aspxUSP Proposes three new Chapters for Heavy Metal Impurity Analysis
/news/2010/01_jan_news.aspxTextduplikat FDA 'Advice' on Validation and Use of Excel®
/news/2010/01_jan_news.aspxNot Putting Finished Drugs on Accelerated Stability Studies Draws FDA Warning
/news/2010/01_jan_news.aspxNew Audio Seminars in 2010 - Schedule Available
/news/2010/01_jan_news.aspxNew FDA Guidance on Assay Development for Immunogenicity Testing
/news/2010/01_jan_news.aspxUpdated FDA Guidance for Non-Clinical Safety Studies
/default1.aspxTrivialer Linktext
Click Here
http://www.labcompliance.com/b...Extern Textduplikat Part11
http://www.labcompliance.com/b...Extern Labcompliance.com
http://www.labcompliance.com/b...Extern ISO 17025 Quality Plan
http://www.labcompliance.com/b...Extern Textduplikat Labcompliance.com
http://www.labcompliance.com/s...Extern Quality by Design for Method Validation
http://www.labcompliance.com/s...Extern Kein Text
http://www.labcompliance.com/s...Extern Textduplikat Labcompliance.com

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