FEATURED ARTICLES

  • Why Data Integrity Is Impossible Without A Quality Culture
    Why Data Integrity Is Impossible Without A Quality Culture

    Quite a bit has been written about data integrity in recent years, and an embedded, effective quality culture remains a critical success factor for fully realizing strong data integrity. In recently published guidance on data integrity, the FDA goes so far as to state very directly that “it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues.”

  • How To Write An Effective Validation Master Plan
    How To Write An Effective Validation Master Plan

    A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.

  • An Analysis Of FDA FY2018 Drug GMP Warning Letters
    An Analysis Of FDA FY2018 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This allows manufacturers and sponsors to identify new trends in the focus of FDA inspectors and to act to address or justify similar situations at their own firms.

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WHITE PAPERS & CASE STUDIES

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PRODUCTS & SERVICES

Pharmaceutical Compliance Packaging Pharmaceutical Compliance Packaging

Pharma Packaging Solutions helps companies create packaging which deals with dosing regimens, patient instructions, patient record keeping and more. For companies needing unique designs to drive medication adherence, there is in-house Creative Service Team to develop specified artwork.

Pharmaceutical Environmental Humidity and Temperature Probes: HygroClip2 Pharmaceutical Environmental Humidity and Temperature Probes: HygroClip2

The HygroClip2 ADVANCED humidity and temperature probes offer you maximum repeatability and an accuracy of ±0.8 %RH and ±0.1 K.

Enterprise Asset Performance Management Software for Life Sciences, Pharma Enterprise Asset Performance Management Software for Life Sciences, Pharma

Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.

Life Sciences Regulatory Compliance Services Life Sciences Regulatory Compliance Services

The Schneider Electric team of dedicated industry experts is focused on providing companies with strict regulatory adherence in a timely and cost-effective manner. This includes comprehensive regulatory compliance and validation services, focused on but not limited to, environmental monitoring systems, building management systems, manufacturing, processing and packaging equipment and automated business systems (MES, laboratory, Information Technology). The Schneider Electric offerings also include quality audits and assessments. Our full range of services and solutions are vendor and platform independent, providing organizations with an objective and authoritative view.

USP 232 And USP 233 Elemental Impurities Compliance USP 232 And USP 233 Elemental Impurities Compliance

Metrics Contract Services offers a complete elemental impurities program designed to comply with the USP 232 and USP 233 Elemental Impurities proposed chapters which become official on December 1, 2015.

Logistics Audit/Assessment & Engineering Solution Services

Modality Solutions provides services such as: cGMP readiness assessments, product characterization and stability studies for distribution, controlled-environment logistics process validation, quality management systems and change control, and thermal packaging design and qualification.

EZ BioPac®: Powder Transfer Process EZ BioPac®: Powder Transfer Process

Advanced Powder Transfer for Media and Buffer preparation and Solids additions.

Regulatory Services 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.

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LIFE SCIENCE WEBINARS

  • Using Positive Controls In Container Closure Integrity Studies
    Using Positive Controls In Container Closure Integrity Studies

    This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.

  • Oxygen Permeation In Pre-Filled Syringes
    Oxygen Permeation In Pre-Filled Syringes

    This webinar presents how to design and conduct studies to assess the total oxygen permeation rate of your pre-filled syringes, and how to determine if the permeation is primarily through the plunger or through the tip.  Protecting oxygen-sensitive formulations during filling will also be discussed. 

  • Non-destructive Moisture Analysis Of Freeze Dried Product
    Non-destructive Moisture Analysis Of Freeze Dried Product

    This webinar describes how non-destructive headspace moisture analysis can be used for characterizing batch moisture distributions, for lyo cycle development and optimization, and for freeze dryer moisture mapping and validation.

  • Determining And Controlling Oxygen Levels In Sensitive Formulations
    Determining And Controlling Oxygen Levels In Sensitive Formulations

    This webinar will review how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.

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REGULATORY COMPLIANCE VIDEOS

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