GUEST COLUMNISTS

  • 4 Tips For Successful Collaboration With Your EU Qualified Person (QP)
    4 Tips For Successful Collaboration With Your EU Qualified Person (QP)

    Qualified Persons (QPs) are responsible for the certification of clinical trial materials in the EU and therefore are an essential link in U.S. sponsors’ supply chains. Indeed, engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated technical, quality, and regulatory challenges.

  • Debunking The Top 3 Myths About Quality By Design (QbD)
    Debunking The Top 3 Myths About Quality By Design (QbD)

    Pharmaceutical quality by design (QbD) and quality risk management (QRM) principles have become mainstays in pharmaceutical development. However, several myths are prevalent that prevent wider acceptance of the concepts by smaller firms. The lack of understanding of pertinent quality by design methods prevents smaller firms from benefiting from the majority of what QbD offers.

  • New EMA Requirements On Nitrosamines: What ALL Pharma Needs To Know
    New EMA Requirements On Nitrosamines: What ALL Pharma Needs To Know

    The EMA recently issued two new publications containing information on nitrosamines for marketing authorization holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.

  • Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project
    Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project

    Faced with competing priorities, teams often rush to turn their plans into projects while missing the important steps in between. Resource planning is chief among these oversights. 

  • Achieving Integrated Quality Through A Continued Process Verification Program
    Achieving Integrated Quality Through A Continued Process Verification Program

    Continued process verification (CPV) is not only required for companies but also is a good investment in product quality and setting the foundation for continuous improvement. 

  • Understanding The FDA’s Knowledge-Aided Assessment & Structured Application (KASA) Framework
    Understanding The FDA’s Knowledge-Aided Assessment & Structured Application (KASA) Framework

    The FDA's new pharmaceutical quality assessment system is intended to capture and manage information about inherent risk and control approaches for product design, manufacturing, and facilities, in a structured format with the intent to facilitate a concise and consistent quality assessment, and largely replace freestyle text.

  • The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial
    The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial

    For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons (QPs) may at times be perceived as a challenge to overcome, because their role and responsibilities are not fully understood. Conversely, part of the QP’s role is to support clinical trials in the EU by certifying compliant clinical trial materials while protecting public health.

  • Are Good Manufacturing Practices No Longer Good Enough?
    Are Good Manufacturing Practices No Longer Good Enough?

    Janet Woodcock’s recent quote on the state of pharmaceutical development — “It’s not working…” — should not be a surprise to anyone. The industry has been struggling for years with long development times, high product failure rates, and frequent quality problems. But, Ms. Woodcock’s further statement — “and, it won’t work in the future” — is an especially troubling call for changes.

More From Our Expert Columnists

PHARMA ONLINE WHITE PAPERS

  • Comparison Of Credo Carbon Footprint To Similar Performance Single-Use Shippers

    Containment will always be needed to protect payloads during transportation. While it is important to the protection of the value of the payload, it has no environmental benefit. It is important for organizations to carefully consider the impact of their containment, packaging, and shipping decisions, especially when high volumes of transactions are involved. Read more about how a reusable logistical approach as opposed to a single-use shipper can considerably reduce the environmental impacts of transporting thermally protected payloads.

  • Guidance For Lab Washer Cleaning In Life Sciences

    The principal concern for any scientist or technician working in the laboratory is that glassware, instruments, and equipment be free of interfering residues.

  • The Definitive Guide To Particle Sizing

    This paper provides an introduction to particle sizing comparing six widely used techniques, explaining how they work and what this means in terms of strengths and limitations. 

  • Accelerate Process Development With High-Throughput, Single-Use, Fully Automated Bioreactors

    Biopharma R&D teams everywhere face the same dilemma in the development of biologics and vaccines: Increase productivity to meet strict budgets and deadlines, while maintaining or improving data accuracy.

  • Biosafety Considerations For Single-Use Bioreactors

    How single-use bioreactors address some of the key challenges the industry faces by decreasing time-to-market, reducing validation efforts, increasing flexibility, reducing investment costs and optimizing cost of goods.

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PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

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This free collection of articles is from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.

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PHARMA INDUSTRY EVENTS

Biotechnology-2019 November 14 - 15, 2019
Amsterdam, FL
33rd European Ophthalmology Congress November 14 - 15, 2019
Madrid, ME
33rd European Ophthalmology Congress November 14 - 15, 2019
Madrid, RI
2nd annual conference on Oralcare and dentistry November 14 - 15, 2019
Istanbul, TN
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TRAINING COURSES

Preparing eCTD Submissions: A Step-By-Step Guide November 19 - 19, 2019
1pm-2:30pm EST, Online Training
Establishing Appropriate Quality Metrics November 21 - 21, 2019
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Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control December 12 - 12, 2019
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