Sat.Jul 01, 2023

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The Importance of a Good Onboarding Process

The Honest Apothecary

In the realm of talent acquisition, the pivotal role of the interviewing process in selecting the right candidates cannot be overstated. After all, it is during these crucial interactions that potential employees showcase their skills, experience, and cultural fit. However, as acclaimed author and business leader Stephen Covey once wisely remarked, “Hire for character, train for skill.” This quote encapsulates a fundamental truth.

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Introducing EU Annex 1: Understanding the Newest Regulatory Requirements

ISPE

Introducing EU Annex 1: Understanding the Newest Regulatory Requirements Trudy Patterson Sat, 07/01/2023 - 06:00 White Paper — Sponsored Content Introducing EU Annex 1: Understanding the Newest Regulatory Requirements 1 July 2023 As its title implies, Annex 1 is the European guidance document for good manufacturing practices of medicinal products. As such, it serves as the road map for sterile drug manufacturers to follow in order to arrive at the pathway to the highest level of sterility, assur

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The Inspection Result: Warning Letters and Form 483s

BioPharm

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

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Thermal Buffering in Temperature Mapping & Monitoring

ISPE

Thermal Buffering in Temperature Mapping & Monitoring Trudy Patterson Sat, 07/01/2023 - 06:00 White Paper — Sponsored Content Thermal Buffering in Temperature Mapping & Monitoring 1 July 2023 Temperature sensors used in critical applications are often placed into a thermal buffering device to ensure that normal and expected fluctuations in temperature-controlled environments do not cause false alarms.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Drug Shortages Continue to Plague FDA and Manufacturers

BioPharm

Problems continue despite actions by regulators to better prevent and address drug shortages.

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The Digital Validation Handbook Your Guide to Faster, More Accurate Validation

ISPE

The Digital Validation Handbook Your Guide to Faster, More Accurate Validation Trudy Patterson Sat, 07/01/2023 - 06:00 White Paper — Sponsored Content The Digital Validation Handbook Your Guide to Faster, More Accurate Validation 1 July 2023 Technology has been changing the way we communicate for almost as long as we’ve been able to send a message from one person to another.

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State of Producer Cell Development for Lentiviral Vector Manufacturing

BioPharm

Despite many development challenges, stable producer cell lines show real promise.

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Drug Pricing’s Static Changes

BioPharm

The debate surrounding drug pricing changes rages on.

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Innovation Idolatry

BioPharm

If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.

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Weighing the Benefits of Single-Use Consumables

BioPharm

Experts outline the benefits of single-use consumables relative to traditional approaches.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Automation Aids Cell and Gene Therapy Production

BioPharm

Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.

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Exploring How CPC Progresses Green Chemistry Practices

BioPharm

CPC presents a green alternative to chromatography that supports sustainable operations.

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Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key Learnings

BioPharm

Use of a small-scale filler can result in increased filling efficiency.

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Choosing the Right Expression System for Complex Modalities

BioPharm

The choice of expression system requires wise consideration of product complexities.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.