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Tag: usfda
New FDA Guidance on the Finalization of several FDA Draft Guidances
https://seetharamkandarpa.webnode.in/news/new-fda-guidance-on-the-finalization-of-several-fda-draft-guidances/
FDA Inspection Reports: What are various results and their significance?
https://seetharamkandarpa.webnode.in/news/fda-inspection-reports-what-are-various-results-and-their-significance-/
U.S. FDA Clearance for Mass Spectrometry
https://seetharamkandarpa.webnode.in/news/u-s-fda-clearance-for-mass-spectrometry/
Cleaning Validation Requirements in Asia
https://seetharamkandarpa.webnode.in/news/cleaning-validation-requirements-in-asia/
USFDA increases inspection staff in India
https://seetharamkandarpa.webnode.in/news/usfda-increases-inspection-staff-in-india/
USFDA Draft Guidance - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection
https://seetharamkandarpa.webnode.in/news/usfda-draft-guidance-circumstances-that-constitute-delaying-denying-limiting-or-refusing-a-drug-inspection/
FDA Warning for Inadequate Storage of Reference Samples and Reagents
https://seetharamkandarpa.webnode.in/news/fda-warning-for-inadequate-storage-of-reference-samples-and-reagents/
European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach
https://seetharamkandarpa.webnode.in/news/european-medicines-agency-and-us-food-and-drug-administration-release-further-guidance-on-quality-by-design-approach/
FDA published List of GMP facilities producing for the US market (generic drug products and APIs)
https://seetharamkandarpa.webnode.in/news/fda-published-list-of-gmp-facilities-producing-for-the-us-market-generic-drug-products-and-apis-/
New FDA Requirement on the Handling of INDs
https://seetharamkandarpa.webnode.in/news/new-fda-requirement-on-the-handling-of-inds1/
More Inspections by USFDA in 2014
https://seetharamkandarpa.webnode.in/news/more-inspections-by-usfda-in-2014/
My new Mobile Application "SRK GCP World"
https://seetharamkandarpa.webnode.in/news/my-new-mobile-application-srk-gcp-world/
New Guidance on Validation of Analytical Methods by USFDA
https://seetharamkandarpa.webnode.in/news/new-guidance-on-validation-of-analytical-methods-by-usfda/
FDA Secure Supply Chain Pilot Program: 13 companies prequalified
https://seetharamkandarpa.webnode.in/news/fda-secure-supply-chain-pilot-program-13-companies-prequalified/
FDA wants to increase Number of foreign Inspections
https://seetharamkandarpa.webnode.in/news/fda-wants-to-increase-number-of-foreign-inspections/
Overview of new CDRH Guidelines
https://seetharamkandarpa.webnode.in/news/overview-of-new-cdrh-guidelines/
FDA plans Changes to the Classification of Medical Devices
https://seetharamkandarpa.webnode.in/news/fda-plans-changes-to-the-classification-of-medical-devices/
FDA published Medical Device Recall Report
https://seetharamkandarpa.webnode.in/news/fda-published-medical-device-recall-report/
FDA published Guidance for Industry on "Investigation Device Exemptions (IDE)"
https://seetharamkandarpa.webnode.in/news/fda-published-guidance-for-industry-on-investigation-device-exemptions-ide-/
Electronic Submissions Presentations by USFDA
https://seetharamkandarpa.webnode.in/news/electronic-submissions-presentations-by-usfda/
US FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products and FDA Questions and Answers
https://seetharamkandarpa.webnode.in/news/us-fda-guidance-for-industry-andas-stability-testing-of-drug-substances-and-products-and-fda-questions-and-answers/
EMA Official Details Obstacles to Reaching Mutual Reliance on GMP Inspections
https://seetharamkandarpa.webnode.in/news/ema-official-details-obstacles-to-reaching-mutual-reliance-on-gmp-inspections/
Sun Pharma gets warning letter from USFDA
https://seetharamkandarpa.webnode.in/news/sun-pharma-gets-warning-letter-from-usfda/
Particles continue to cause major compliance problems and recalls
https://seetharamkandarpa.webnode.in/news/particles-continue-to-cause-major-compliance-problems-and-recalls/
India's Data Integrity Problems
https://seetharamkandarpa.webnode.in/news/indias-data-integrity-problems/
Regulators Again Find Data Integrity Problems at Indian Manufacturing Site
https://seetharamkandarpa.webnode.in/news/regulators-again-find-data-integrity-problems-at-indian-manufacturing-site/
FDA launches openFDA to provide easy access to valuable FDA public data
https://seetharamkandarpa.webnode.in/news/fda-launches-openfda-to-provide-easy-access-to-valuable-fda-public-data/
USFDA Warning Letter to Novacyl Wuxi Pharmaceutical Co., Ltd. 12/19/14
https://seetharamkandarpa.webnode.in/news/usfda-warning-letter-to-novacyl-wuxi-pharmaceutical-co-ltd-12-19-14/
USFDA Inspections/483s Dashboard
https://seetharamkandarpa.webnode.in/news/usfda-inspections-483s-dashboard/
USFDA 483s Published in 2014 by USFDA
https://seetharamkandarpa.webnode.in/news/usfda-483s-published-in-2014-by-usfda/
USFDA Warning Letters- Drugs Updates
https://seetharamkandarpa.webnode.in/news/usfda-warning-letters-updates/
New Guidance on Environmental Assessments for Biotechnology Products by USFDA
https://seetharamkandarpa.webnode.in/news/new-guidance-on-environmental-assessments-for-biotechnology-products-by-usfda/
FDA warns consumers not to use muscle growth product called Tri-Methyl Xtreme
https://seetharamkandarpa.webnode.in/news/fda-warns-consumers-not-to-use-muscle-growth-product-called-tri-methyl-xtreme/
FDA's New Pharmaceutical Quality Approach- One Quality Voice
https://seetharamkandarpa.webnode.in/news/fdas-new-pharmaceutical-quality-approach-one-quality-voice/
U.S. Marshals seize unapproved drugs from Florida distributor
https://seetharamkandarpa.webnode.in/news/u-s-marshals-seize-unapproved-drugs-from-florida-distributor/
USFDA Guidance on "ANDA Submissions- Refuse-to-Receive Standards" Effective from 26 May 2015
https://seetharamkandarpa.webnode.in/news/usfda-guidance-on-anda-submissions-refuse-to-receive-standards-effective-from-26-may-2015/
USFDA Draft Guidance on "Conditions: Reportable CMC Changes for Approved Drug and Biologic Products" Effective from 29 May 2015
https://seetharamkandarpa.webnode.in/news/usfda-draft-guidance-on-conditions-reportable-cmc-changes-for-approved-drug-and-biologic-products-effective-from-29-may-2015/
New final Guidance from USFDA related to Pharmaceutical Quality/CMC on 'Analytical Procedures and Methods Validation for Drugs and Biologics
https://seetharamkandarpa.webnode.in/news/new-final-guidance-from-usfda-related-to-pharmaceutical-quality-cmc-on-analytical-procedures-and-methods-validation-for-drugs-and-biologics/
USFDA published a final rule (FDA-2011-N-0898 Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products)
https://seetharamkandarpa.webnode.in/news/usfda-published-a-final-rule-fda-2011-n-0898-permanent-discontinuance-or-interruption-in-manufacturing-of-certain-drug-or-biological-products/
New Draft Guidance from USFDA on 'Request for Quality Metrics
https://seetharamkandarpa.webnode.in/news/new-draft-guidance-from-usfda-on-request-for-quality-metrics/
Quality Metrics: Industry Reaction to FDA's Draft Guidance
https://seetharamkandarpa.webnode.in/news/quality-metrics-industry-reaction-to-fdas-draft-guidance/
FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy
https://seetharamkandarpa.webnode.in/news/fda-allows-marketing-of-first-direct-to-consumer-app-for-contraceptive-use-to-prevent-pregnancy/
FDA issues final guidance entitled Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances
https://seetharamkandarpa.webnode.in/news/fda-issues-final-guidance-entitled-dissolution-testing-and-acceptance-criteria-for-immediate-release-solid-oral-dosage-form-drug-products-containing-high-solubility-drug-substances/
FDA Launches New Medication Guide Database - Drug Information Update
https://seetharamkandarpa.webnode.in/news/fda-launches-new-medication-guide-database-drug-information-update/
cGMP Guidelines
https://seetharamkandarpa.webnode.in/products/product-1/
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About Me
SEETHARAM KANDARPA
Seetharam Kandarpa Receives ASQ-Certified Manager of Quality/Organizational Excellence
Web Series 2 of ASQ CQA Mentoring Class: Auditing Fundamentals on 30 July 2017
Overview of ASQ Certified Pharmaceutical GMP Professional (CPGP)
Web Series Session 1: Overview of ASQ Certified Quality Auditor conducted on 21 May 2017
Register to Join Mentoring Class for ASQ-CQA
Mentoring Class for ASQ-CQA
G.ONE (GMP-ONE)- One Spot for all GMP Links required in our JEEVAN
Seetharam Kandarpa Receives ASQ Quality Auditor
Seetharam Kandarpa Receives ASQ-Certified Pharmaceutical GMP Professional
ISO 9001: 2008 Quality Management Systems – Requirements
My new Mobile Application "SRK GCP World"
MACO Calculation Sheet in Cleaning Validation
My new Mobile Application "SRK GMP Videos"
"SRK CLEANING VALIDATION"- My new mobile application
"SRK GMP OCEAN"- My Mobile Application Works for Android & HTML5
"SRK GMP FAQ"- My new Mobile Application
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