| TITLE |
# COMMENTS |
LATEST |
| Seven Signs that Your Quality Program Is in Trouble | 7 | 04/13/11 03:54PM |
| Reducing Human Error on the Manufacturing Floor | 0 | |
| New Commercial Models for New Market Realities | 0 | |
| Defining GxP Training / Learning: Part 1 | 0 | |
| Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program | 3 | 04/29/13 04:46PM |
| Computer System Validation: FDA Inspections | 1 | 09/29/10 04:55AM |
| Automating Training Control Processes to Comply with FDA and ISO Requirements | 0 | |
| ISO 9001: Quality Objectives and Quality Dreams | 0 | |
| Effective Nonconformance Management Key to FDA and ISO Compliance | 1 | 02/13/11 08:57PM |
| Quality Basics Simplify Complex Engineering Document Management Challenge | 0 | |
| Conducting a Clinical Trial in Europe from the Perspective of a U.S. Virtual Company | 0 | |
| Change Control – Continuous Quality Improvement in FDA and ISO Environments | 2 | 12/26/10 04:49AM |
| 19 Key Elements to Review for Effective Procurement Audits | 5 | 11/09/10 07:57AM |
| Did you know that a newly issued final rule will affect the way that Pharmaceutical, Biologics and Contract Organizations report adverse events during clinical trials? | 0 | |
| Four Common Quality Misconceptions | 0 | |
| Assessing the Proposed Changes to the US FDA's 510(k) Programme | 0 | |
| Do you know what 'readily available' means in the context of 21 CFR Part 11 documentation? | 0 | |
| Did you know that the FDA is developing a standardized format for REMS? | 0 | |
| Why Baldrige Works | 0 | |
| Did you know that the FDA is currently taking comments on the recently issued PGx Draft Guidance for Pharmaceutical Manufacturers? | 0 | |
| Quality Inspiration | 3 | 04/14/11 04:04PM |
| Did you know that MasterControl's software suite is now offered in Chinese, French, German, Japanese, Korean, and Spanish in addition to its English version? | 0 | |
| How to Avoid Common IND Submission Pitfalls | 0 | |
| Certification and Advanced Degrees: Are They Worth It? | 4 | 07/28/11 03:43PM |
| Management Review - Measuring the "Heartbeat" of Your Quality Management System | 0 | |
| Writing and Enforcing Your SOPs for GxP Compliance Success | 1 | 07/13/11 12:31PM |
| Do you know how to navigate the FDA's website when searching for FDA warning letter information? | 0 | |
| How to Build a Business Case for a Quality Management System | 0 | |
| Preparing for a Safety Inspection | 0 | |
| Did you know that the FDA has recently introduced a new strategy for ensuring the safety and quality of imported products? | 0 | |
| Did you know that seven pharmaceutical companies submitted a joint citizen petition asking the FDA for clarification regarding off-label use manufacturer-communications? | 0 | |
| Four ‘Dos and Don’ts’ for Handling Warning Signs about an Approved Drug | 0 | |
| What to Expect When They're Inspecting - Part 1 | 0 | |
| Reading the FDA Tea Leaves | 0 | |
| Annex 11 and 21 CFR Part 11: Comparisons for International Compliance | 0 | |
| End-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals | 0 | |
| Four Common Quality Misconceptions | 10 | 07/26/11 01:17AM |
| Did you know that according to a recent ASQ survey, companies are expressing concern that BPO (Business Process Outsourcing) providers are falling short? | 0 | |
| Developing a Supplier Scorecard | 3 | 04/15/11 12:08PM |
| Did you know that the FDA is considering a "Super Office" of Drug Safety? | 0 | |
| Transfer Comparability and Co-validation | 0 | |
| Is there a legal requirement to have SOPs for GCP in Europe? | 0 | |
| Good Clinical Practice: From Review to Application | 0 | |
| Annex 11: The EU's New Expectations for Regulated Computerized Systems | 0 | |
| What to Expect When They're Inspecting - Part 2 | 0 | |
| The Rising Costs of Clinical Trials | 0 | |
| The New Life Science Solution and its Implications on Document Management for Pharmaceutical Companies | 4 | 05/14/13 09:45AM |
| MasterControl Presents 'Change Control--a Risk-Based Approach' at MD&M Texas | 0 | |
| The Odd Couple: Quality vs. Research (R&D) | 0 | |
| The Rising Costs of Clinical Trials | 0 | |
| Is FDA to Blame for Biomedical Industry's Slow Growth? | 0 | |
| The "Supply Chain" Patient is Sick: Is There a Cure for the Pharma Supply Chain? - Part I | 0 | |
| Outsourcing Trends for 2012 - Top Services by Customer Segment and the Prevalence of Contracting to Emerging Markets | 0 | |
| FDA Says Part 11 Guidance Remains Status Quo | 0 | |
| How Mobile Technology Can Help You in Data Collection | 0 | |
| Clinical CAPA: CAPA Isn't Just for Manufacturing Anymore | 0 | |
| When Good Teams Go Wrong | 0 | |
| Process Verification vs. Process Validation: What You Need to Know | 0 | |
| Risk-Based Approach to Monitoring: The Value of Data in Clinical Studies | 0 | |
| Implementing a New System: Why Training Reinforcement is Critical | 0 | |
| How to "Sell" Quality | 0 | |
| Can You Use Automated Testing Tools as an FDA-Regulated Company? | 0 | |
| Regulations Vary Worldwide but Risk Management is Common Demoninator | 0 | |
| Vivian Bringslimark 100% Training Complete ? 100% Effectively Trained | 0 | |
| Regulatory Submissions: Filling the Critical Gaps in EDM Systems | 0 | |
| How to Build a Strong Supply Chain Team | 1 | 05/07/13 02:33AM |
| FDA User Fees: What Have They Done for You Lately? | 1 | 04/26/13 08:36PM |
| Clinical Research: Common Challenges in Sponsor-CRO Relationship | 0 | |
| Developing a QMS: Should You Buy or Build? | 1 | 05/05/13 06:15AM |
| The U.S. Biosimilar Pathway Nearly Three Years Later | 0 | |
| Transitioning from an FMEA Risk Analysis to a Total Risk Management System | 2 | 05/02/13 01:51AM |
| Highlights of the 2012 Revised EU Pharmacovigilance Regulations | 0 | |
| The EMA Guidance for Process Validation | 1 | 05/15/13 09:10PM |
| Creating, Staffing and Managing an Inspection War Room | 0 | |
| Surviving the Hosted Compliance Audit: Front Line, Back Room and in the Shop | 0 | |
| Clinical CAPA: CAPA Isn't Just for Manufacturing Anaymore | 0 | |
| FDA Issues Draft Guidance on Biosimilar Product Development | 0 | |
| Quantifying Quality for GxP Compliance | 0 | |
| The Importance of Computer Systesm I/Os Accuracy Checks | 0 | |
| Challenges in Combination Product Regulation | 0 | |
| Remote Audit: Out of Sight but Not Out of Mind | 0 | |
| Five CAPA Tips that Help Ensure Compliance | 1 | 05/05/13 05:31AM |
| Peeling the Onion to Improve Human Reliability | 0 | |
| Quality Professionals: How to Increase Your Job Security | 0 | |
| MasterControl Revs Operational Excellence Using Six Sigma | 1 | 05/05/13 04:04AM |
| Introduction to High Risk Software Automated Testing | 0 | |
| Correcting and Detecting CAPA Horrors | 2 | 04/30/13 12:10AM |
| Business Benefits of Archiving | 1 | 05/05/13 02:34PM |
| Implementing a Systems Approach to Pharmaceutical Quality Systems | 1 | 04/27/13 08:47AM |
| The European Qualified Person - What's It All About? | 0 | |
| Avoiding Remediation with a Good QMS | 0 | |
| SPC vs SQC: The Strategic Difference | 0 | |
| Did you know that the FDA has published a new guidance for the pharmaceutical industry? | 0 | |
| Product Risk Management Under ISO 14971:2007 and ICH Q9 | 2 | 03/23/11 01:08AM |
| Do you know the dos and don'ts of FDA inspections? | 0 | |
| How to Avoid Common IND Submission Pitfalls | 0 | |
| The "Supply Chain" Patient is Sick: Is There a Cure for the Pharma Supply Chain? - Part II | 0 | |
| Contract Management: What's Compliance Got to Do with it? | 0 | |
| Hamburg Speaks about Innovation at FDLI Annual Conference | 0 | |
| Writing and Enforcing Your SOP for GxP Compliance Success - Part 2 | 3 | 07/14/11 08:11PM |
| New Report Highlights Need to Reduce R&D Cost | 0 | |
| Quality and Risk Management in Clinical Studies | 1 | 04/29/13 06:42PM |
| U.S. Agencies Should Take Steps to Boost Developing Nations' Regulatory Capacity to Ensure That Imported Foods and Drugs Are Safe | 0 | |
| Corrective Action and Preventive Action: What's the Difference? | 0 | |
| How Social Media Is Advancing Healthcare | 0 | |
| Ways to Ensure Supplier Compliance | 0 | |
| How Life Science Companies Can Leverage Mobile Technology | 0 | |
| Surviving the Back Room During an FDA Inspection | 1 | 05/16/13 06:07AM |
| Drug Accountability in Clinical Trials | 0 | |
| FDA Fields Tough Questions About Inspections, Challenges Pharma to Be Open, Honest | 0 | |
| Is Quality by Design just for Big Pharma? | 0 | |
| Trends in Q1 FDA Warning Letters | 0 | |
