GXP Digital Edition 1 YEAR - (JG_gdigi)
WEB SEMINAR CD: Standardization of Instrument Qualification, Re-Qualification and Calibration in Pharmaceutical Research and Development Laboratories - (040108WC)
Web Seminar CD: A Statistical Basis for Quality by Design - (041008wc)
Computer System Validation
October 14-16, 2008 - (IVTC-csv1008)
WEB SEMINAR CD: FDA Inspections: Learning from the Experience of Others PART2 - How to Prepare - (041608wc)
WEB SEMINAR CD: FDA Inspections: Learning from the Experience of Others PART 1 - What to Expect - (031108wc)
14th Annual International VALIDATION WEEK
October 21-23, 2008 - (IVTC-VW1008)
5th Annual Method Validation
October 14-16, 2008 - (IVTC-MV1008)
Labeling Laboratory Reagents and Solutions - (NWRS4201)
Receipt and Handling of Human Specimens - (NWRS4191)
Analysis of Test and Control Article Formulations - (NWRS4181)
Formulation of Test and Control Articles - (NWRS4171)
Disposition and Archiving of Test and Control Articles - (NWRS4162)
Audit of Test and Control Article Accountability - (NWRS4151)
Test and Control Article Receipt, Handling, and Storage - (NWRS4141)
Test and Control Article Characterization - (NWRS4131)
Submission of Test and Control Articles - (NWRS4121)
Master Schedule - (NWRS4111)
Initiation, Revision, Distribution, and Control of Standard Operating Procedures - (NWRS4102)
Deviation Reporting - (NWRS4093)
Protocol and Protocol Amendments - (NWRS4081)
Training Study Personnel - (NWRS4072)
Duties and Responsibilities of Study Personnel - (NWRS4061)
Duties and Responsibilities of the Quality Assurance Unit - (NWRS4051)
Duties and Responsibilities of the Study Director - (NWRS4041)
Duties and Responsibilities of Testing Facility Management - (NWRS4031)
Testing Laboratory-Sponsor Contracts - (NWRS4021)
Conduct of a Nonclinical Laboratory Study - (NWRS4011)
PharmSep Symposium
September 9-11, 2008 - (IVTC-PSEP0908)
Web Seminar CD:Current FDA Thinking on Computerized Systems in Clinical Investigation - (092707WC)
WEB SEMINAR CD: A Comprehensive Approach to the Facilities and Equipment Subsystem of QSIT - (082307WC)
Cleaning Validation And Critical Cleaning Processes
July 14-17, 2008 - (IVTC-CV0708)
WEB SEMINAR CD Series: Advanced Topics in LC Method Validation - (ATCR8718)
WEB SEMINAR CD Series: Validation Basics A-Z: Planning, Implementing & Maintaining - (VBCR6107)
Pharmaceutical Technology's Third Annual QPEC Conference
July 21-23, 2008 - (IVTC-PT0708)
WEB SEMINAR CD: cGMP Informatics - IT Infrastructure Design for 21st Century Pharmaceutical Quality Control and Quality Assurance Operations - (082907WC)
The Cleaning Validation Toolkit - (IVT_CVTK)
Change Control Combo SPECIAL OFFER - (CCCombo)
Web Seminar CD: Risk Based Approach to cGMP Systems - (080707WC)
Web Seminar CD: Deviations in Handling Deviations in the Microbiological Laboratory - (070607WC)
Web Seminar CD: Trend Data - (062607WC)
Web Seminar CD: Cleaning Validation Strategies for Success: Grouping and Bracketing of Products and Equipment - (062507WC)
Web Seminar CD: Cleaning & Cleaning Validation: An Overview - (062007WC)
Web Seminar CD: Commissioning and Qualification Risk Assessment - (061407WC)
Web Seminar CD: Managing International FDA Inspections - (053107WC)
Web Seminar CD: Pay Now or Pay (More!)Later: Optimizing the Computer Systems Maintenance Phase - (051707WC)
Web Seminar CD: The New Process Validation FDA Perspective - Basis for the Revision to the 1987 FDA PV Guideline - (050307WC)
Web Seminar CD: How to Handle OOS Stability Results-When Do You Need to Alert the Regulators? - (043007WC)
Web Seminar CD: Proper Documentation and SOPs to Ensure Compliance in the Lab - (041907WC)
Web Seminar CD: Writing Scientific Rationales for Cleaning Validation: Balancing Risk and Regulation - (032107WC)
Web Seminar CD: Acceptance Criteria and Test Method Validation - (041207WC)
Web Seminar CD: CAPA: A Risk Mitigating Quality System - (040407WC)
Handbook to Laboratory Best Practices, Training and Facing Challenges - (HBLAB07)
Handbook to GMP Training, Compliance & Risk Management Solutions: A European Perspective - (HBGMPEU07)
Web Seminar CD: ISO 14971 and Q9 Risk-based Validation Planning - (031407WC)
Web Seminar CD: Developing and Validating LC Stability Indicating Assays - (032807WC)
Web Seminar CD: Proper Design and Maintenance of GMP Training Program with Emphasis on New FDA and Industry Trends - (030807WC)
Web Seminar CD: Forming a Partnership Between IT and QA: How to Achieve IT Quality the Right Way - (022207WC)
Web Seminar CD: Site Validation Master Planning - (022807WC)
Librarian Special GXP Offer - (GXP_Lsub1yr)
Librarian Special JVT Offer - (JVT_Lsub1YR)
Web Seminar CD: Quality Systems and Risk Management: A Multi-national Approach - (021407WC)
Web Seminar CD: How to Conduct a Gap Analysis on your Quality Systems to comply with the FDA Guideline and future ICH Q10 requirements - (013107WC)
Web Seminar CD: A Comprehensive Approach to Microbial OOS Investigations in Purified Water Systems in Pharmaceuticals - (012507WC)
Web Seminar CD: Retirement Planning: Your GXP Computer System's IRA - (011607WC)
Handbook: Good Clinical Practice 21CFR Parts 11, 50, 54, 56, 312 & 314 - (HB115307)
FDA Main Toolkit - (FDAMTK)
FDA CD Toolkit - (FDAWCTK)
FDA Print Toolkit - (FDAPTK)
Web Seminar CD: Are You Doing The Right Thing? Choosing Your Chinese API/FDF Suppliers Wisely - (011107WC)
INT'L: Journal of GXP Compliance Subscription 2 year - (JG_gxpI2)
DOMESTIC: Journal of GXP Compliance Subscription 2 Year - (JG_gxpD2)
INT'L: Journal of GXP Compliance Subscription 1 Year - (JG_gxpI)
DOMESTIC: Journal of GXP Compliance Subscription 1 Year - (JG_gxpD)
DOMESTIC: JVT Subscription 2 Year - (JG_jvtD2)
INT'L: JVT Subscription 2 Year - (JG_jvtI2)
DOMESTIC: JVT Subscription 1 Year - (JG_jvtD)
INT'L: JVT Subscription 1 Year - (JG_JVTI)
Medical Device Design Control Program - (BIODL01)
Web Seminar CD: Cleaning Validation Recovery Study Rescues: Guidelines to Make Recovery Studies Simple - (121906WC)
Web Seminar CD: Standardization Of Instrument Qualification, Re-Qualification And Calibration. . . - (121206WC)
Web Seminar CD: Using FDA Warning Letter Trends to Create a Proactive Compliance Environment - (113006WC)
Web Seminar CD: Mock FDA Inspection - (111506WC)
Event CD: Understanding the Sliding Scale of 21 CFR Part 11: Learning from the Past to Shape the Future - (telesemCD122006)
Event CD: Environmental Monitoring: The True Reasons - (telesemCD120606)
COMBO PACKAGE: Special Edition: Corrective and Preventive Action plus CD: Corrective Action Preventive Action (CAPA): A Risk Mitigating Quality System - (CAPAC)
Web Seminar CD: Packaging of Clinical Trial Supplies: Organization to Cope with Randomization - (110606WC)
CD ONLY: Investigating Out-of-Specification (OOS) Test Results Implementing the New FDA Final Guidance - (telesemCD_121306)
Web Seminar CD: Cleaning Validation Limits: Limiting the Confusion - (101706WC)
Teleseminar: (CD) Nov 21, 2006 - (telesemCD112106)
SOP Library - (NWRSALL)
Teleseminar CD: Marketing and Selling Medical Devices in the EU: Emphasis on MDD 93/42/EEC and CE Marking - (telesemCD110106)
Event CD: Best Practices in 510(k) Submissions and Achieving Compliance Success with FDA - (telesemCD112906)
Event CD: Developing a Site Master File - An EU Requirement - (telesemCD111706)
Web Seminar CD: Simplifying Vendor Qualification: Increasing Reliability and Reducing Testing Costs - (092606WC)
Vendor and Supplier Quality Management: Doing it Right! - (telesemCD102706)
Biological Industry Pocket Guide - (PG611006)
CD ONLY: Corrective Action Preventive Action (CAPA): A Risk Mitigating Quality System - (telesemCD101806)
EVENT CD: Good Laboratory Practice (GLP): The Basics - (telesemCD100406)
Event CD: Validation Protocol Development and Acceptance Criteria - (telesemCD092706)
FDA Inspections of Sponsor Site - (NWRS3021)
Adverse Event Reporting for Drugs by Sponsors - (NWRS3020)
Sponsor Reporting Requirements for Drugs - (NWRS3019)
Numbering Study Protocols, Clinical Trials Sites, Investigators, Contract Laboratories and Subjects - (NWRS3018)
Institutional Review Board Evaluation by a Sponsor - (NWRS3017)
Institutional Review Board Requirements - (NWRS3016)
Sponsor's Responsibilities - (NWRS3015)
Sponsor - Investigator Agreement - (NWRS3014)
Investigator Selection and Agreement - (NWRS3013)
Evaluation and Selection of a Contract Research Organization - (NWRS3012)
Informed Consent - (NWRS3011)
Monitoring of Clinical Sites - (NWRS3010)
Clinical Site Training - (NWRS3009)
Clinical Study Initiation Visit - (NWRS3008)
Pre-Study Site Visit - (NWRS3007)
Sponsor's Clinical Record Retention Policies - (NWRS3006)
Investigational Supplies Management by Sponsor - (NWRS3005)
Managing a Pharmacovigilance Program - (NWRS3004)
Preparation of Clinical Protocols - (NWRS3003)
Quality Assurance Audits of Clinical Trial Activities - (NWRS3002)
FDA Inspections of Clinical Sites - (NWRS3001)
Preparation of Quality Plan - (NWRS2001)
Line Clearance - (NWRS1702)
Production and Process Control - (NWRS1701)
Hygiene - (NWRS1602)
Training - (NWRS1601)
Stability Studies - (NWRS1402)
Retest - (NWRS1401)
Laboratory Notebooks - (NWRS1308)
Customer Complaint (Medical Devices) - (NWRS1307)
Medical Device Reporting - (NWRS1306)
Record Retention - (NWRS1305)
Completion of Quality Records - (NWRS1304)
Quality System Record - (NWRS1303)
Device History Records - (NWRS1302)
Device Master Records - (NWRS1301)
Selection, Qualification and Monitoring of Contract Manufacturers - (NWRS1204)
Qualification and Monitoring of Suppliers - (NWRS1203)
Purchasing Controls - (NWRS1202)
Qualification and Monitoring of Service Providers - (NWRS1201)
Equipment Maintenance and Calibration - (NWRS1101)
Material Receiving - (NWRS1002)
Handling and Storage of Material - (NWRS1001)
Packaging Control - (NWRS0902)
Labeling Control - (NWRS0901)
Product Inspection, Testing and Approval - (NWRS0802)
QA Product Approval - (NWRS0801)
Material Identification - (NWRS0701)
Deviations - (NWRS0606)
Nonconformances - (NWRS0605)
Failure Investigation - (NWRS0604)
Material Review Board - (NWRS0603)
Recall - (NWRS0602)
CAPA - (NWRS0601)
Risk Management for Medical Devices - (NWRS0502)
Management Representative - (NWRS0403)
Management Responsibility - (NWRS0402)
Management Review - (NWRS0401)
FDA Inspections - (NWRS0303)
Supplier Audits - (NWRS0302)
Internal Quality Audits - (NWRS0301)
Assignment of Expiration Date - (NWRS0202)
QA Responsibilities - (NWRS0201)
Assignment of Lot Numbers - (NWRS0109)
Assignment of Part Numbers - (NWRS0108)
Preparation of Manufacturing Batch Records - (NWRS0107)
Engineering Change Order - (NWRS0106)
Preparation of Test Methods - (NWRS0105)
Preparation of Final Release Specifications - (NWRS0104)
Preperation of Raw Material Specifications - (NWRS0103)
Preperation of SOP's - (NWRS0102)
Document Initiation, Revision, Distribution and Control - (NWRS0101)
Teleseminar CD: Master Planning for Validation: Doing it Right! - (telesemCD083006)
EVENT CD: Good Manufacturing Practice, Validation and Change Control: A Bird's Eye View of the Principles Involved - (telesemCD082306)
Pharmaceutical Industry GMP’s 21 CFR Parts 210 & 211 - (PG101106)
Process Validation Combo - (PVCB)
Event CD: Root Cause Analysis: Examining the Options - (telesemCD081006)
EVENT CD: When Systems Fail, CAPA Validation Begins, What Does That Mean? Implementing Corrective and Preventive Action Effectively - (telesemCD092006)
IVT Operations Combo - (OPSC)
Analytical Method Validation and Analytical Method Validation, Vol. II - (AMVC)
EVENT CD: Guidelines and Methodologies for Proper Handling of Laboratory Investigations -Effectively Managing Out of Trend (OOT) Situations - (telesemCD080406)
Event CD: Proper Documentation and SOPs to Ensure Laboratory Compliance - (telesemCD072806)
Environmental Monitoring Handbook - (HBEM06)
Cleaning Validation Handbook - (CVHB)
EVENT CD: The How-to Guide for Effective Cleaning and Cleaning Validation - (telesemCD071206)
Teleseminar: (CD) Auditing a Validation Program a Risk-Based Approach - (telesemCD072106)
Telseminar: (CD) Understanding FDA's New Medical Device Innovation Initiative - (telesemCD062906)
Event CD: The Validation Life Cycle and Change Control: A Regulatory Imperative - (telesemCD062206)
Event CD: Effective Elements of a Successful Disinfectant Validation Program - (telesemCD060806)
Event CD: Identifying and Resolving GMP Issues for Pharmaceutical Process and Facility Design - (telesemCD061306)
Event CD: Understanding the ASTM Draft Standard Guide - (telesemCD060606)
x - (mindee)
cleaning test - (TEST)
The Special Edition: Conducting Audits - (SECGCA)
Event CD: Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Facilities: Causes and Effective Solutions to Prevent OOS Events and Excursions - (telesemCD052406)
download - (test_mks)
EVENT CD: PROCESS ANALYTICAL TECHNOLOGY (PAT): Understanding the Impact on Pharmaceuticals Manufacturing And Validation Needs/Requirements - (telesemCD053106)
Event CD: Facilities Issues For Young Biotech Companies: A Case Study - (telesemCD051606)
The Special Edition: Process Validation - (SEPROV)
The Special Edition: Analytical Methods Validation, Vol. II - (SEANMV)
Event CD: Effective Compliance Integration - Maintaining Compliance, especially post Mergers and Acquisitions - (telesemCD050506)
FDA Current Enforcement Initiatives and Guidance - (FDAINT)
Special Edition: Equipment and Instrumentation - (SEEIQ)
Event CD: Good Laboratory Practice (GLP): The Basics - (telesemCD042706)
Event CD: Using Risk Assessment as a Planning Tool for IT - (telesemCD041806)
Teleseminar (CD ONLY): April 20, 2006 - (TelesemCD042006)
Event CD: Case Study in Commissioning and Validation: Application of Commissioning and Validation to a cGMP Project - (telesemCD041206)
Event CD: Validation Protocol Execution and Addressing Deviations - (TelesemCD033006)
Event CD: Validation Protocol Development and Acceptance Criteria - (TelesemCD032406)
Event CD: Revalidation versus Effective Monitoring and Change Control: Is Revalidation Really Necessary? - (TelesemCD032106)
Event CD: The Challenges of Implementing a Centralized Change Control Management System - (TelesemCD032806)
Event CD: Failure Mode and Effects Analysis (FMEA): A Quantitative Method to Identify Risk in a Production Environment - (TelesemCD031506)
Post Your Career Opportunity with IVT - (JOBPOST)
CD ONLY: Guidelines and methodologies for Proper Handling of Laboratory Investigations (e.g. Out of Trend [OOT]) - (TelesemCD70)
CD ONLY: Introduction to Computer Validation Key Aspects of a Computer Validation Program – Regulatory Expectations and Strategies for Implementation - (TelesemCD030106)
Event CD: Strategies and Approaches for an Effective Design Qualification/Review - (TelesemCD022806)
CD ONLY: Critical Documentation Requirements for Successful Validation in the Pharmaceutical Industry - (TelesemCD022306)
CD ONLY: Analytical Instrument Qualification (AIQ) Understanding the New USP Draft Guidance <1058> - (TelesemCD022206)
CD ONLY: A Comprehensive Approach to Microbial OOS (Out of Specification) Investigations in Purified Water Systems in Pharmaceuticals - (TelesemCD021406)
Adequate and Practical Implementation of Change - (TelesemCD020706)
Event CD: Reducing Risk in your Projects/Products by Leading your People More Effectively - (TelesemCD61)
Strategic Pharmaceutical Project/Product Decisions - (TelesemCD60)
Event CD: Effective Application of the ICH Q9 – Quality Risk Management Guideline - (TelesemCD59)
CD ONLY: Analytical Instrument Qualification (AIQ) Understanding the New USP Draft Guidance <1058> - (TelesemCD58)
EVENT CD: Environmental Monitoring: The True Reasons - (TelesemCD57)
Event CD: Master Planning for Validation - (TelesemCD56)
Special Report: Topic of the Day Training Program - (TOD)
Preventing Regulatory Crisis in an FDA-Regulated E - (TGPRC)
Implementing a Quality System - (TG-LC)
Technical Guide: Implementing a Cleaning Validation Program for the Biotechnology and Biological Industries - (TG5)
Using Global GMP Regulations and Guidance - (TG4)
Technical Guide: The Validation Life Cycle of a Biotechnology Derived Drug Product - (TG2)
Technical Guide: Validating and Establishing a Routine Environmental Monitoring Program - (TG1)
ELECTRONIC RECORDS; ELECTRONIC SIGNATURES: PART 11 - (TELERES)
Process Validation Toolbox, Equipment Qualificatio - (TBO)
Six Sigma and Process Validation Strategies - (SSPVS)
Special Report - Good Laboratory Practice - (SRGLP)
Supplier Qualification Toolbox - (SQT)
Special Edition - Computer Validation V - (SEV03)
Special Edition: Medical Device Compliance - (SEMDC)
Computer Validation IV - (SEIV)
Special Edition: Computer Validation III - (SEIII99)
Effective Documentation Practices - (SE-DP)
Conducting Effective Calibrations - (SE-CEC)
Special Edition - Change Control Implementation - (SECC)
Special Edition: Computer Validation II - (SE98)
A Practical Guide to Change Control System Managem - (SDCC)
A Roadmap to Conducting an Effective Cleaning Prog - (RCP)
Quality Improvement Handbook - (QIH)
Process Validation Toolbox: - (PVTBX)
Protocol and Standard Operating Procedure - (PSVLI)
Handbook - Procedure Design and Implementation: - (PRES1)
A Pocket Guide To Auditing a Pharmaceutical Water - (PG-AWS)
The Validation Dictionary - (LX)
Special Edition: Laboratory Compliance - (LCSE)
Experience Migrating Mass Spectrometry Data Betwee - (JVTV8N3-250)
Remaining in a 21 CFR Part 11 Compliant State - (GXPV6N3-6)
Quality Control of Serological Tests and Applicati - (GXPV6N3-41)
Toolbox: Good Manufacturing Practice - (GMPTB)
Facility Validation: A Case Study for Integrating - (FVGW)
FDA Documents - FDA Regulatory Documents - (FDA21CFR)
Ask the FDA: A Collection of Interviews - (FDA10)
Special Edition: Implementing 21 CFR Part 11; Elec - (ESERSO)
Special Edition II: Electronic Records; Electronic - (ESERSEII)
Special Edition - Implementing 21 CFR Part 11; Electronic Records; Electronic Signatures - (ERESSE)
Equipment Qualification Toolbox - (EQTBX)
Technical Guide: Conducting Effective Medical Device Validations - (DRD)
Glossary of Computerized System and Software Dev - (CSSDT)
Existing Biopharmaceutical Manufacturing Processes - (CPBV)
Cleaning Validation III - (CLNVALIII)
Special Edition: Cleaning Validation - (CLNVAL)
Special Edition = cGMP Training II - (CGTII)
Special Edition: cGMP Training - (CGT)
Computer Diskette Library - (CDL)
Special Report: Change Control - (CCJG)
Journal of Validation Technology, February 2002, V - (BI02-02)
Journal of Validation Technology, February 2001, V - (BI02-01)
Intro. to Validation From A-Z + 1yr subscription to JVT and to GXP (US) - (A-ZJG)
Introduction to Validation from A to Z - (A-ZJ)
Intro. to Validation From A-Z - (A-ZG)
Intro. to Validation From A-Z + - (A-ZFJG)
Intro. to Validation From A-Z + 1yr subscription t - (A-ZFJ)
Intro. to Validation From A-Z + 1yr subscription to Journal of GXP Compliance - (A-ZFG)
Intro. to Validation From A-Z - (A-Z)
Special Report: Auditing - (ASJG)
Special Edition: Analytical Method Validation - (AMV)
Auditing Handbook - (AH)
Setting Limits for Cleaning Validation A + B - (9CV)
Special Edition: Implementing Electronic Records - (ESERSE)
Computer Validation Master Planning - (CVMP)
Special Edition: Cleaning Validation II - (CLNVALII)
Special Edition: Facility Qualification - (SEFQ)
Computer Validation VI - (SEVVI)
Special Edition: Corrective and Preventive Action - (SECPA)
Special Edition: Utilities Qualification - (SEUQ)
A Pocket Guide to cGMP Sampling - (PGCGMP)
Special Edition FDA Conference Report - (SRFDA)
INT'L: Journal of GXP Compliance Subscription - (GXP_SUB1YR_INTL)
INT'L: JVT Subscription - (JVT_SUB1YR_INTL)
DOMESTIC: Journal of GXP Compliance Subscription - (GXP_SUB1YR)
DOMESTIC: JVT Subscription - (JVT_SUB1YR)