SEETHARAM KANDARPA
Homepage
About Me
Contact Me
Our Team
Knowledge Bank
Key Info
Useful Info
Videos
ASQ Certification
ASQ-CQA
ASQ-CPGP
News
Blog
Homepage
>
Tag list
Tag: seetharam kandarpa
"SRK GMP OCEAN"- My Mobile Application Works for Android & HTML5
https://seetharamkandarpa.webnode.in/news/srk-gmp-ocean-my-android-application/
My new Mobile Application "SRK CLEANING VALIDATION
https://seetharamkandarpa.webnode.in/news/my-new-mobile-application-srk-cleaning-validation/
My new Mobile Application "SRK GMP FAQ"
https://seetharamkandarpa.webnode.in/news/test/
My new Mobile Application "SRK GMP Videos"
https://seetharamkandarpa.webnode.in/news/my-new-mobile-application-srk-gmp-videos/
My new Mobile Application "SRK GCP World"
https://seetharamkandarpa.webnode.in/news/my-new-mobile-application-srk-gcp-world/
Elemental impurities: ICH Q3D has reached step 4 (final guideline)
https://seetharamkandarpa.webnode.in/news/elemental-impurities-ich-q3d-has-reached-step-4-final-guideline-/
Seetharam Kandarpa Receives ASQ Quality Auditor
https://seetharamkandarpa.webnode.in/news/seetharam-kandarpa-receives-asq-quality-auditor/
Seetharam Kandarpa Receives ASQ-Certified Pharmaceutical GMP Professional
https://seetharamkandarpa.webnode.in/news/seetharam-kandarpa-receives-asq-certified-pharmaceutical-gmp-professional/
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/
GMP Non-compliance reports (AGEPHA, Austria) Published by EMA
https://seetharamkandarpa.webnode.in/news/gmp-non-compliance-reports-agepha-austria-published-by-ema/
GMP Non-compliance reports (North China Pharmaceutical Group Semisyntech Co., Ltd, China) Published by EMA
https://seetharamkandarpa.webnode.in/news/gmp-non-compliance-reports-north-china-pharmaceutical-group-semisyntech-co-ltd-china-published-by-ema-/
USFDA 483s Published in 2014 by USFDA
https://seetharamkandarpa.webnode.in/news/usfda-483s-published-in-2014-by-usfda/
ISO 9001: 2008 Quality Management Systems – Requirements
https://seetharamkandarpa.webnode.in/news/iso-9001-2008-quality-management-systems-requirements/
Good manufacturing practice: data integrity definitions by MHRA
https://seetharamkandarpa.webnode.in/news/good-manufacturing-practice-data-integrity-definitions-by-mhra/
FDA Commissioner Margaret Hamburg to Resign Next Month
https://seetharamkandarpa.webnode.in/news/fda-commissioner-margaret-hamburg-to-resign-next-month/
Concept paper on the revision of EU GMP Annex 1– manufacture of sterile medicinal products
https://seetharamkandarpa.webnode.in/news/concept-paper-on-the-revision-of-eu-gmp-annex-1-manufacture-of-sterile-medicinal-products/
MHRA Warns of People Impersonating its Staff
https://seetharamkandarpa.webnode.in/news/mhra-warns-of-people-impersonating-its-staff-/
GMP Pre-Inspection Compliance Documents published by MHRA
https://seetharamkandarpa.webnode.in/news/gmp-pre-inspection-compliance-documents-published-by-mhra/
Final EU GMP Annex 15 Qualification & Validation- Effective from 01 October 2015
https://seetharamkandarpa.webnode.in/news/final-eu-gmp-annex-15-qualification-validation-effective-from-01-october-2015/
EU Commission released two final Guidelines on GMP for Excipients and GDP for APIs
https://seetharamkandarpa.webnode.in/news/eu-commission-released-two-final-guidelines-on-gmp-for-excipients-and-gdp-for-apis/
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/
Revision of GMP Data Integrity Definitions from MHRA
https://seetharamkandarpa.webnode.in/news/revision-of-gmp-data-integrity-definitions-from-mhra/
Health Canada Vanessa's Law, effective from November 2014
https://seetharamkandarpa.webnode.in/news/health-canada-vanessas-law-effective-from-november-2014/
TGA finalised the specificationfor the Australian eCTD format submissions
https://seetharamkandarpa.webnode.in/news/tga-finalised-the-specificationfor-the-australian-ectd-format-submissions/
WHO Called for Increased Transparency in Medical Research
https://seetharamkandarpa.webnode.in/news/who-called-for-increased-transparency-in-medical-research/
Indian Government to amend SCHEDULE Y of D&C Rules pertaining to authenticity of data submitted by applicants
https://seetharamkandarpa.webnode.in/news/indian-government-to-amend-schedule-y-of-d-c-rules-pertaining-to-authenticity-of-data-submitted-by-applicants/
Health Canada Launched New Drug and Product Inspections Database
https://seetharamkandarpa.webnode.in/news/health-canada-launched-new-drug-and-product-inspections-database/
FDA's New Pharmaceutical Quality Approach- One Quality Voice
https://seetharamkandarpa.webnode.in/news/fdas-new-pharmaceutical-quality-approach-one-quality-voice/
White paper on "Raising Quality Results on Supplier Audits Using EQMS for Pharmaceutical Companies"
https://seetharamkandarpa.webnode.in/news/white-pape-on-raising-quality-results-on-supplier-audits-using-eqms-for-pharmaceutical-companies/
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 WHO TRS 992 (May 2015) having guidance on Hold time study, Process validationand stirage & transport of products
https://seetharamkandarpa.webnode.in/news/new-who-trs-992-may-2015-having-guidance-on-hold-time-study-process-validationand-stirage-transport-of-products/
Notice by CDSCO regarding administrative action by concerned licensing authority (Dated 04/06/2015)
https://seetharamkandarpa.webnode.in/news/notice-by-cdsco-regarding-administrative-action-by-concerned-licensing-authority-dated-04-06-2015/
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/
Update of Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) [EudraLex - Volume 2]
https://seetharamkandarpa.webnode.in/news/update-of-guideline-on-the-packaging-information-of-medicinal-products-for-human-use-authorised-by-the-union-july-2015-eudralex-volume-2/
Recent Non-compliance Reports Published by EudraGMDP
https://seetharamkandarpa.webnode.in/news/non-compliance-reports-published-by-eudra-gmdp/
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/
EDQM released new edition of Technical Guide for the Elaboration of Monographs
https://seetharamkandarpa.webnode.in/news/edqm-released-new-edition-of-technical-guide-for-the-elaboration-of-monographs/
APIC revised the "How to do" Document on ICH Q7
https://seetharamkandarpa.webnode.in/news/apic-revised-the-how-to-do-document-on-ich-q7/
New GMP Implementing Act published by EU
https://seetharamkandarpa.webnode.in/news/new-gmp-implementing-act-published-by-eu/
Consultation on EU GMP Guidelines, revised Annex 17 on the Real Time Release Testing
https://seetharamkandarpa.webnode.in/news/consultation-on-eu-gmp-guidelines-revised-annex-17-on-the-real-time-release-testing/
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
https://seetharamkandarpa.webnode.in/news/european-medicines-agency-pre-authorisation-procedural-advice-for-users-of-the-centralised-procedure/
WHO Draft on 'SUPPLEMENTARY GUIDELINES ON GMP FOR HVAC SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS'
https://seetharamkandarpa.webnode.in/news/who-draft-on-supplementary-guidelines-on-gmp-for-hvac-systems-for-non-sterile-pharmaceutical-dosage-forms/
IPEC Federation Published Position Paper on Third Party Audit and Certification Programmes
https://seetharamkandarpa.webnode.in/news/ipec-federation-published-position-paper-on-third-party-audit-and-certification-programmes/
Training presentation on 'How to conduct an effective internal quality audit'
https://seetharamkandarpa.webnode.in/news/training-presentation-on-how-to-conduct-an-effective-internal-quality-audit/
Training Presentation on 'ICH Q10: Pharmaceutical Quality System'
https://seetharamkandarpa.webnode.in/news/training-presentation-on-ich-q10-pharmaceutical-quality-system/
Training Presentation on 'ICH Q9: Quality Risk Management'
https://seetharamkandarpa.webnode.in/news/training-presentation-on-ich-q9-quality-risk-management/
Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances
https://seetharamkandarpa.webnode.in/news/reflection-paper-on-the-chemical-structure-and-properties-criteria-to-be-considered-for-the-evaluation-of-new-active-substance-nas-status-of-chemical-substances/
ISO 14644 - Part 1: Final Version on Cleanroom Classification
https://seetharamkandarpa.webnode.in/news/iso-14644-part-1-final-version-on-cleanroom-classification/
Best Practice Guide for Quality Agreements published
https://seetharamkandarpa.webnode.in/news/best-practice-guide-for-quality-agreements-published/
Packaging: Pharmeuropa Draft Chapters regarding PVC
https://seetharamkandarpa.webnode.in/news/packaging-pharmeuropa-draft-chapters-regarding-pvc/
GCP - Implementing Regulation on Inspection Procedures
https://seetharamkandarpa.webnode.in/news/gcp-implementing-regulation-on-inspection-procedures/
EMA revises Guide on Pharmaceutical Water
https://seetharamkandarpa.webnode.in/news/ema-revises-guide-on-pharmaceutical-water/
Recognition of Alternative Compendia (BP/EP/JP) by the FDA
https://seetharamkandarpa.webnode.in/news/recognition-of-alternative-compendia-bp-ep-jp-by-the-fda/
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017
https://seetharamkandarpa.webnode.in/news/meeting-highlights-from-the-committee-for-medicinal-products-for-human-use-chmp-18-21-april-2017/
Regulatory information - adjusted fees for applications to EMA from 1 April 2017
https://seetharamkandarpa.webnode.in/news/regulatory-information-adjusted-fees-for-applications-to-ema-from-1-april-2017/
MHRA's Interpretation of Cross Contamination & PDEs
https://seetharamkandarpa.webnode.in/news/mhras-interpretation-of-cross-contamination-pdes/
EMA Q&A on GCP
https://seetharamkandarpa.webnode.in/news/ema-q-a-on-gcp/
Mentoring Class for ASQ-CQA and ASQ-CPGP
https://seetharamkandarpa.webnode.in/news/mentoring-class-for-asq-cqa-and-asq-cpgp/
ASQ-CQA Exam questions vs chapters vs level of cognition
https://seetharamkandarpa.webnode.in/news/asq-cqa-exam-questions-vs-chapters-vs-level-of-cognition/
Mentoring Classes for ASQ-CQA
https://seetharamkandarpa.webnode.in/news/mentoring-classes-for-asq-cqa/
Mentoring Class for ASQ-CQA
https://seetharamkandarpa.webnode.in/news/mentoring-class-for-asq-cqa/
Web Series Session 1: Overview of ASQ Certified Quality Auditor conducted on 21 May 2017
https://seetharamkandarpa.webnode.in/news/web-series-session-1-overview-of-asq-certified-quality-auditor-conducted-on-21-may-2017/
Overview of ASQ Certified Pharmaceutical GMP Professional (CPGP)
https://seetharamkandarpa.webnode.in/news/coming-soon/
Web Series 2 of ASQ CQA Mentoring Class: Auditing Fundamentals on 30 July 2017
https://seetharamkandarpa.webnode.in/news/web-series-2-of-asq-cqa-mentoring-class-auditing-fundamentals-on-30-july-2017/
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 publishes revised MAPP, ANDA Suitability Petitions (5240.5)
https://seetharamkandarpa.webnode.in/news/fda-publishes-revised-mapp-anda-suitability-petitions-5240-5/
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/
Brexit preparedness: EMA to further temporarily scale back and suspend activities
https://seetharamkandarpa.webnode.in/news/brexit-preparedness-ema-to-further-temporarily-scale-back-and-suspend-activities/
Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products
https://seetharamkandarpa.webnode.in/news/targeted-stakeholder-consultation-on-the-draft-guidelines-on-good-clinical-practice-for-advanced-therapy-medicinal-products/
cGMP Guidelines
https://seetharamkandarpa.webnode.in/products/product-1/
G.ONE (GMP-ONE)- One Spot for all GMP Links required in our JEEVAN
https://seetharamkandarpa.webnode.in/products/g-one/
Search site
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
DO YOU FEEL TO COMMENT ON THIS WEBSITE? PLEASE GO TO GUESTBOOK...
DO YOU WANT TO PARTICIPATE IN KNOWLEDGE DISCUSSION FORUM?
To view updated/ new content, click tag "WHAT IS NEW"....
DO Dd
Homepage
Site map
RSS
Print
This website was built with Webnode
You can also have an impressive website for free!
Try it out