FEATURED ARTICLES
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Strong Data Is Generated By Strong PeopleBy Joanna Gallant, Joanna Gallant Training Associates
In the event you’ve been living under a rock for the last several months, facility inspection information released by FDA has thrust data integrity into the spotlight. As someone who had responsibility for assuring laboratory data quality in the past, I find the recent spate of issues reported in FDA warning letters and 483s to be extremely disconcerting. Each subsequent revelation becomes more unbelievable. The good news is that steps to ensure data integrity are completely within our control – assuming we will put the time into executing them.
- Impact Of Strategic Outsourcing On QA Oversight By Sponsor Companies
- FDA And Industry Experts Offer Guidance For DQSA Preparation
- Janet Woodcock’s Quality Agenda At CDER
- Women In Bio Profile: Industry Insights From The Executive Director Of Compliance At Seattle Genetics
WHITE PAPERS & CASE STUDIES
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Don’t Get Blindsided By New USP Quality StandardsThe U.S. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years – and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December 2013. By Dirk Ahlbrecht, Sartorius Group
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Points To Consider When Developing A TMF (Trial Master File) StrategyMany organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). By Karen Redding, Global Business Development Director, Phlexglobal Ltd.
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3 Tips For Safe, Secure Healthcare ShippingAll businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical
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5 Steps To A Reliable CAPA ProcessIt sounds simple, but lack of CAPA process documentation is a frequent reason for FDA 483 citations. Planning and organization lay the foundation for a strong CAPA program.
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Mitigating Risk To Compliance With Integrated Quality SystemsThe North American company in this white paper is a global leader in the field of filtration, separation and purification processing equipment for the pharmaceutical, biotech and industrial markets.
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Using Collaborative Review And Authoring Technology Increases Productivity And Drives Value Across The CompanyConatus Pharmaceuticals Inc. is headquartered in San Diego, California and is a privately-held biotechnology company focused on the development of human therapeutics to treat liver disease and cancer. Currently, the company’s primary activity is based on the clinical trials for the treatment of Hepatitis C Virus.
PRODUCTS & SERVICES
EZ BioPac™: Powder Transfer Process
Advanced Powder Transfer for Media and Buffer preparation and Solids additions.
Regulatory Services
If you need help preparing and submitting your API regulatory applications, Cedarburg Hauser Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.
LIFE SCIENCE WEBINARS
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H.R. 3204 Drug Quality And Security ActAfter so many years of struggling with how to comply with the California ePedigree requirement, we now need to know how to comply with the new federal requirement, H.R. 3204. This webinar will review DQSA requirements and timelines.
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Top Things To Consider When Evaluating Your Vendor’s Security Of Supply StrategiesThe biopharmaceutical industry’s increasingly complex global supply chains, often involving single-source supplier arrangements, are made vulnerable by uncertain financial environments and unpredictable natural disasters.
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Successfully Managing The Risks And Challenges Of Orphan Drugs
Orphan drugs, while life changing and in many cases life saving for patients, are fraught with challenges for biotech and pharmaceutical manufacturers. These range from locating the patients and their physician caregivers, to making sure the patients can pay for these therapies, to the overcoming the numerous risk points in moving very expensive and in most cases temperature controlled goods to patients all over the globe. This webinar looks at addressing these issues. The experienced speakers will guide you through the salient points and considerations when dealing with these challenges.
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The Cost of Failure In Pharma Development: A Risk for Everyone
Predicting potential problems serves no purpose if it is not accompanied by adequate corrective actions or mitigation strategies to address them. This webinar will also discuss risk mitigation options for both early and late stage development programs.