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GUEST COLUMNISTS

  • What Organizational Design Says About Your Commitment To Data Integrity
    What Organizational Design Says About Your Commitment To Data Integrity

    Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.

  • Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom
    Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom

    Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.

  • Does A Phase 1 Virtual Biopharma Company Need A cGMP Quality System?
    Does A Phase 1 Virtual Biopharma Company Need A cGMP Quality System?

    Virtual pharmaceutical/biotech companies often receive conflicting advice regarding the need to establish an internal cGMP quality system. Either they’re told “you need an extensive set of cGMP SOPs” or “you don’t need any cGMP SOPs at all.” Which advice is correct?

  • 4 Important Things To Consider Before Developing A Drug Delivery Device
    4 Important Things To Consider Before Developing A Drug Delivery Device

    This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development.

  • 2019 U.S. State Policy Trends Impacting Pharma Manufacturers
    2019 U.S. State Policy Trends Impacting Pharma Manufacturers

    If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.

  • How To Prepare For An FDA Inspection
    How To Prepare For An FDA Inspection

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections and will generally result in inspectional observations.

  • Is Continuous Manufacturing A Good Fit For Generic Drug Products?
    Is Continuous Manufacturing A Good Fit For Generic Drug Products?

    Continuous manufacturing (CM), though well recognized by regulators and technology providers as a means to improve product quality, has seen a slow pace of adoption within the generic manufacturing sector. This article discusses the challenges and mitigation strategies for adoption of CM by generic drug product manufacturers.

  • 3 Surefire Approaches To SOP Harmonization
    3 Surefire Approaches To SOP Harmonization

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

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PHARMA ONLINE WHITE PAPERS

  • Aggregation In Pharma: The Future-Proof Solution
    Aggregation In Pharma: The Future-Proof Solution

    This white paper highlights the fact that there are no limits to progress in the pharma industry and provides an insight into the improvement potential of all processes in the supply chain using aggregation.

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PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

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Free collection of articles exploring topics including the various types of risks associated with medicinal products, the role of risk management in pharmaceutical and biopharmaceutical regulation, QRM principles and practices, the role of QRM across the product life cycle, primary literature sources for QRM, and common challenges associated with QRM implementation.

PHARMA INDUSTRY EVENTS

INTERNATIONAL CONFERENCE ON HEART & DIABETES August 19 - 20, 2019
Osaka, AL
7th World Heart Congress August 19 - 20, 2019
Vienna, VT
World Congress on Chemistry August 19 - 20, 2019
Kuala Lumpur
Biohe 2019 August 19 - 20, 2019
Kuala Lumpur,, LA
World Heart Congress 2019 August 19 - 20, 2019
London, VA
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TRAINING COURSES

Lyophilization - An Introduction to the Scientific Principles August 27 - 27, 2019
1pm-2:30pm EST, Online Training
The Top Method Validation Mistakes – And How to Avoid Them September 9 - 9, 2019
1pm-2:30pm EDT, Online Training
Pediatric Clinical Trials: Special Considerations and Requirements September 13 - 13, 2019
1pm-2:30pm EDT, Online Training
How to Write SOPs That are GCP Compliant and Implementable September 17 - 17, 2019
1pm-2:30pm EDT, Online Training
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