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2018 Technical Education Program

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  • "Advantages of Continuous Manufacturing for Solid Dosages"

    04/17/2018, 10:15 AM - 11:15 AM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • PDA Roundtable: State of the Industry Practices for Pre Use Post-Sterilization Integrity Testing

    04/17/2018, 10:30 AM - 11:30 AM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    • Language: English

  • Pharmaceutical Technology Keynote Series

    04/17/2018, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

    • Language: English

  • Integrating a Programmable Robotic Bioreactor System with a Biochemical Analyzer for Real-time Analysis

    04/17/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    High-throughput bioreactor robotic systems have started to replace traditional, labor and time intensive methods of using shake flasks and stirred tank reactors...

    • Language: English

  • Bioprocess Simulations – the means to decision making from Feasibility through Detailed Design

    04/17/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Speed to market continues to be a critical need for pharmaceutical companies expanding and/or launching new products to the marketplace. Whether it's deploying ...

    • Language: English

  • Accelerating Freeze-Drying: From Model to Production of a Semi-Continuous Aseptic Spray Freeze-Dryer

    04/17/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    Freeze drying has traditionally been a batch process making it both, time consuming and energy intensive (Rambhatla et al., 2003; Liu et al., 2008). While the u...

    • Language: English

  • A Molecule’s Journey – Breaking Down Roadblocks to Commercial Success - Navigating through the important considerations necessary to successfully bring a biologic molecule to market

    04/17/2018, 10:30 AM - 11:15 AM, TBD

    When bringing a molecule from the bench to market, there are many important considerations that biopharma executives must take into account throughout the journ...

    • Language: English

  • "Formulation and Non-Invasive Delivery of Biologics"

    04/17/2018, 11:15 AM - 12:00 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Impact of Tank Cone Bottom Interior Angle on Agitator Design, Lowest Mixable Volume, and Process Results

    04/17/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    The pharmaceutical and biotechnology industries often utilize vessels with cone bottoms. Cone bottoms are selected to enhance product recovery and improve clean...

    • Language: English

  • Data Integrity and Management in the Pharmaceutical Industry. Understanding and Complying with GMP & FDA requirements.

    04/17/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    ♦Today, both the MHRA and FDA are highly focused on data integrity and currently discourage methods by which data is recorded manually. Modern data management s...

    • Language: English

  • Cleaning Validation – Different approaches to limit setting for detergents

    04/17/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Cleaning validation projects involve a lot of different departments and resources within pharmaceutical manufacturing. One of the most critical steps within th...

    • Language: English

  • Building the Foundation for Continued Process Verification with Industry 4.0 Manufacturing Analytics

    04/17/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    The quest by leading pharmaceutical and life sciences companies to achieve Continued Process Verification has begun in earnest. Originally a guidance issued by ...

    • Language: English

  • CRB Tech Tank: Flexible Manufacturing - Adapt or Die!

    04/17/2018, 1:30 PM - 2:15 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    Your business has to be flexible to survive and thrive. A flexible facility tailored to the business needs of your company will save you money. A flexible facil...

    • Language: English

  • Tablet Press and Encapsulating Machine Transactions

    04/17/2018, 1:30 PM - 2:15 PM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    Effective in 2017, transactions involving tableting and encapsulating machines must be reported to the Import/Export Unit at the Drug Enforcement Administration...

    • Language: English

  • Start-ups – Moving out of the Incubator into a New Pilot/Manufacturing Facility

    04/17/2018, 1:30 PM - 2:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Start-up companies often have their beginnings in a crowded flex space. After years of research and testing, they finally developed a viable product. This is ...

    • Language: English

  • Remediation Challenges of Aging Facilities

    04/17/2018, 1:30 PM - 2:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Aging is an unavoidable part of a facility's life cycle. It is imperative that the facility owner constantly evaluate the impact of aging to the prime purpose ...

    • Language: English

  • Pharmaceutical Technology Keynote Series

    04/17/2018, 1:30 PM - 3:00 PM, INTERPHEX Innovation Stage

    • Language: English

  • "Pharma Intelligence: 2018 Industry Outlook"

    04/17/2018, 1:30 PM - 2:15 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • "Biosimilars 4.0"

    04/17/2018, 2:15 PM - 3:00 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • CRB Tech Tank: Keep 'em separated! Integrating segregation for gene vector production

    04/17/2018, 2:30 PM - 3:15 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    Don't wait until your facility is overrun! Come learn how CRB approaches effective strategies for segregation of viral vector production, as found in gene thera...

    • Language: English

  • Single use viable air monitoring in critical environments of a specialty multi-purpose contract manufacturing organization

    04/17/2018, 2:30 PM - 3:15 PM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    The absence of microbial contaminations is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safe...

    • Language: English

  • Optimized Manufacturing of mAb-based Products: Flexibility, Speed, and Efficiency can Co-exist

    04/17/2018, 2:30 PM - 3:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    The manufacture of mAb-based products represents a large portion of many company's drug substance pipeline. In order to ensure that critical business goals focu...

    • Language: English

  • On-dose identification for tablets and capsules – dosage design and equipment innovation to mitigate risks in patient safety and brand protection

    04/17/2018, 2:30 PM - 3:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Many business needs can be satisfied by providing unique identification on solid oral dosage forms. But there is truly only one purpose: patient safety. Manag...

    • Language: English

  • "Vaccine Innovation"

    04/17/2018, 3:00 PM - 3:45 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • CRB Tech Tank: Solving demand allocation problem with modeling and simulations

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    For a multi-site organization, allocating demands can be a challenging problem. Computer simulations, in conjunction with mathematical modeling, can be used to ...

    • Language: English

  • Risk analysis: Present state and industry's demand

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Risk analysis: Present state and industry's demand Dr. A. Fedotov, Clean Technologies LLC, Moscow, Russia 1. ICH Q9/EU GMP on risk analysis – are they correct ...

    • Language: English

  • Case Study: Capacity Expansion and Conversion to Single-Use BioProcessing at an Existing cGMP CDMO Facility

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    With growing demand in the biologics CDMO market, Merck KGaA (Darmstadt, Germany) elected to expand capacity at its existing cGMP biomanufacturing facility in M...

    • Language: English

  • A Case Study for an Improved Approach to Cleanroom Disinfection, Minimizing the Impact and Reducing Downtime

    04/17/2018, 3:30 PM - 4:15 PM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    One of the key areas for ensuring that cleanrooms remain within microbiological and particulate specifications as laid out in ISO 14644 or Annex 1 of GMP is dis...

    • Language: English

  • "The Impact of Critical Utilities"

    04/17/2018, 3:45 PM - 4:30 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Settling the Frontier of Fill-Finish Operations – High Tech Filling in a Proper Abode

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Fill/finish operations represent perhaps the last frontier of significant risk in manufacturing injectable medicines. Closed systems in compounding and formulat...

    • Language: English

  • Process Economics: The Driving Force behind the Criteria for Cell Therapies Facility Design

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Today's small number of approved cellular therapy products (13 FDA-approved), a large number of clinical trials (>10,000), and favorable regulatory climate, as ...

    • Language: English

  • Integrating IoT into your Life Sciences Packaging and Supply Chain Strategy - Best Practices to Take this Valuable Leap

    04/17/2018, 4:15 PM - 5:00 PM, INTERPHEX Innovation Stage

    In today's world, technology is advancing every second. The Internet of Things phenomenon has enabled groundbreaking advances in connected devices and personali...

    • Language: English

  • Continuous OSD: Designing a Controls Model

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    Continuous processing holds the promise of revolutionizing our approach to manufacturing and quality, but that promise is based on having a fully developed proc...

    • Language: English

  • A Novel, Real Time Adaptive Process Control System for Optimizing Feeding in Bioreactors

    04/17/2018, 4:15 PM - 5:00 PM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    An in-line process monitoring system and method for in-situ, real time monitoring and control of nutrient and carbon source feeding in bioreactors is described....

    • Language: English

  • "Show Wrap Up Day 1"

    04/17/2018, 4:30 PM - 4:45 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Data-driven Control Strategy for Critical Drug Container Closure Systems (CCS) Performance at Digital Age

    04/18/2018, 12:00 AM - 1:00 AM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    The container closure integrity (CCI) performance is essential for drug product quality throughout the entire sealed drug product life cycle, and it is predomin...

    • Language: English

  • IPS Technologies Tours - The Track to Serialization: Solutions to Safeguard Your Products

    04/18/2018, 10:00 AM - 12:00 PM, Lobby Mezzanine

    • Language: English

  • IPS Technologies Tours - iCON TM : The Turnkey Facility of the Future Here Today. Are you iCON ready?

    04/18/2018, 10:00 AM - 12:00 PM, Lobby Mezzanine

    • Language: English

  • IPS Technologies Tours - Flexible Parenteral Manufacturing - Seed to Vial

    04/18/2018, 10:00 AM - 12:00 PM, Lobby Mezzanine

    • Language: English

  • IPS Technologies Tours - Critical Utilities: The lifeblood of your facility

    04/18/2018, 10:00 AM - 12:00 PM, Lobby Mezzanine

    • Language: English

  • IPS Technologies Tours - Containment Band Reunion: Process Containment for OSD and Parenteral Manufacturing

    04/18/2018, 10:00 AM - 12:00 PM, Lobby Mezzanine

    • Language: English

  • IPS Technologies Tour - Continuous Manufacturing Principles: Linking Unit Operations and Eliminating Intermediate Bulk Storage

    04/18/2018, 10:00 AM - 12:00 PM, Lobby Mezzanine

    • Language: English

  • "New Regulations, Real Case Studies: ASME BPE Cabinet Washer Standards (SD-5.3.1)

    04/18/2018, 10:15 AM - 11:00 AM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Ensuring reliable, consistent production in pharmaceutical water systems

    04/18/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    Design and quality of water system equipment play a big role in optimizing pharmaceutical manufacturing - a huge, profitable and easily accessible potential. W...

    • Language: English

  • Pharmaceutical Technology Keynote Series

    04/18/2018, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

    • Language: English

  • Making "Spray and Pray" Obsolete with New Technologies

    04/18/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    Title: Making "Spray and Pray" Obsolete with New Technologies. Objective: This presentation describes the limitations of spraying and wiping items and componen...

    • Language: English

  • DME Facility Focus 1: Flexibility by Design: GMP Manufacturing for the Diverse Product Portfolio

    04/18/2018, 10:30 AM - 11:30 AM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    GMP facilities are increasingly challenged to accommodate production diversity, adapt to evolving business needs, and deliver high quality products with low cos...

    • Language: English

  • Cleaning Agent Screening: Key Aspects in Selecting a Suitable Cleaning agent for a GMP Cleaning Procedure

    04/18/2018, 10:30 AM - 11:15 AM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    The recent shift from traditional cleaning validation to a cleaning life cycle approach emphasizes the requirement for scientifically sound decisions in the des...

    • Language: English

  • "Automation Trends Facing the Industry"

    04/18/2018, 11:15 AM - 12:00 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Verifiable Containment Performance of Isolator Technologies

    04/18/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    With the advent of increasingly potent compounds such as HPAPIs, ADCs, etc within the pharmaceutical industry, the focus on containment solutions and their abil...

    • Language: English

  • The use of extractables data from Single Use components for risk assessment

    04/18/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    It has been over a decade since the first single use components were utilised with biopharmaceutical manufacturing. Single-Use technologies are now established ...

    • Language: English

  • Integrating IoT into your Life Sciences Packaging and Supply Chain Strategy - Best Practices to Take this Leap

    04/18/2018, 11:30 AM - 12:15 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    • Language: English

  • IPS Technologies Tours - The Track to Serialization: Solutions to Safeguard Your Products

    04/18/2018, 1:00 PM - 3:00 PM, Lobby Mezzanine

    • Language: English

  • IPS Technologies Tours - iCON TM: The Turnkey Facility of the Future Here Today. Are you iCON ready?

    04/18/2018, 1:00 PM - 3:00 PM, Lobby Mezzanine

    • Language: English

  • IPS Technologies Tours - Flexible Parenteral Manufacturing - Seed to Vial

    04/18/2018, 1:00 PM - 3:00 PM, Lobby Mezzanine

    • Language: English

  • IPS Technologies Tours - Critical Utilities: The lifeblood of your facility

    04/18/2018, 1:00 PM - 3:00 PM, Lobby Mezzanine

    • Language: English

  • IPS Technologies Tours - Continuous Manufacturing Principles: Linking Unit Operations and Eliminating Intermediate Bulk Storage

    04/18/2018, 1:00 PM - 3:00 PM, Lobby Mezzanine

    • Language: English

  • IPS Technologies Tours - Containment Band Reunion: Process Containment for OSD and Parenteral Manufacturing

    04/18/2018, 1:00 PM - 3:00 PM, Lobby Mezzanine

    • Language: English

  • DME Facility Focus 2: Restrictive Access Barriers: Best industry practices for retrofitting a legacy filling lines with a RABS barrier.

    04/18/2018, 1:00 PM - 2:00 PM, Technical Conference Stage 1, Booth 1076, Exhibit Hall

    Many long-time manufacturers of sterile drug products will eventually wrestle with the "RABS versus Isolator" decision, which is, whether to build new isolator-...

    • Language: English

  • Mass Spectrometry in Freeze Drying, Over 25 Years since the First Installation: How Far have we Come?

    04/18/2018, 1:15 PM - 2:00 PM, Technical Conference Stage 3, Booth 1376, Exhibit Hall

    Mass Spectrometers have commonly been used in the semi-conductor industry where maintaining a clean environment with minimum contaminants under high vacuum is c...

    • Language: English

  • Harmonized Method for Cleanroom Hard Surface Disinfectant Efficacy Evaluations

    04/18/2018, 1:15 PM - 2:00 PM, Technical Conference Stage 4, Booth 1477, Exhibit Hall

    Disinfectant efficacy validation testing can be a daunting task as there are various factors to consider. There are a number of standardized test methods availa...

    • Language: English

  • Global pharmaceutical packaging trends, beyond Serialization

    04/18/2018, 1:15 PM - 2:00 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    The session will consist of a thorough walk-trough of world map updated regulatory requirements as well as supply chain stakeholder's demands and needs. Deep di...

    • Language: English

  • Pharmaceutical Technology Keynote Series

    04/18/2018, 1:30 PM - 3:00 PM, INTERPHEX Innovation Stage

    • Language: English

  • "Utilizing AR/VR in Pharma Development and Manufacturing"

    04/18/2018, 1:30 PM - 2:15 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

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