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2018 Technical Education Program

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  • Formulation and Delivery of Biologics and Complex Small Molecule Compounds

    04/17/2018, 10:15 AM - 11:00 AM, INTERPHEX Live, Crystal Palace CP-2
    • Language: English

  • MasterControl Inc.: Automating the Human Element in Production

    04/17/2018, 10:30 AM - 11:00 AM, Technical Conference Stage 5, Booth 1677, Exhibit Hall

    The benefit of automating human involvement in production and the cost vs return. The continual improvement process to drive process changes, utilizing low cost...

    • Language: English

  • Driving Digital Transformation in Chemistry & Advanced Materials Industry through Decision Support Information Solutions

    04/17/2018, 10:30 AM - 11:15 AM, FormulationX Stage Booth 4005
    • 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: Oral Solid Dosage Manufacturing - Employing the Internet of Things and PAT for Solid Dosage Forms Manufacturing:

    04/17/2018, 10:30 AM - 10:55 AM, INTERPHEX Innovation Stage

    Research underway at Innopharm Labs' pilot facility in Dublin, Ireland, combines the concepts of Industrial Internet of Things (IoT), Industry 4.0, machine-to-m...

    • 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, CMO/CDMO Theatre Booth 1053

    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

  • Pharmaceutical Technology Keynote Series: Oral Solid Dosage Manufacturing - PCMM OSD Manufacturing Facility Platform

    04/17/2018, 11:00 AM - 11:25 AM, INTERPHEX Innovation Stage

    The PCMM Collaboration brought together the expertise of Pfizer, GSK, GEA, and G-CON to collectively develop the next generation OSD manufacturing platform to a...

    • Language: English

  • Advantages of Continuous Manufacturing for Solid Dosages

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

  • MilliporeSigma: Flexibility Without Compromise – A Novel Approach to Single-Use System Design to Increase Speed, Reduce Costs and Enhance Supply Reliability

    04/17/2018, 11:30 AM - 12:00 PM, Technical Conference Stage 5, Booth 1677, Exhibit Hall

    The benefits of single-use technologies are well known throughout the industry, but as the number of process consumables increase, so does the complexity to man...

    • Language: English

  • The Perks and Pitfalls of a Single-Use Biopharmaceutical Facility

    04/17/2018, 11:30 AM - 12:15 PM, CMO/CDMO Theatre Booth 1053
    • Language: English

  • Streamlined Manufacture of Modified-Release Matrix Tablets via Direct Compression

    04/17/2018, 11:30 AM - 12:15 PM, FormulationX Stage Booth 4005

    This session will provide an overview of direct compression and wet granulation processes including updated information on how to remove production cost and exc...

    • Language: English

  • Pharmaceutical Technology Keynote Series: Oral Solid Dosage Manufacturing - Continuous Manufacturing Roundtable: Best Practices for Implementation

    04/17/2018, 11:30 AM - 12:30 PM, INTERPHEX Innovation Stage

    The pharmaceutical industry has made progress in implementing continuous manufacturing for oral solid-dosage drugs. Commercial processes have been approved, and...

    • 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

  • Lunch and Learn: SUEZ (GE Analytical Instruments) - Getting the most out of TOC: Improve cleaning process understanding and monitor leachables /extractables

    04/17/2018, 12:15 PM - 1:15 PM, Technical Conference Stage 2, Booth 1177, Exhibit Hall

    TOC and conductivity are required tests to meet compendial requirements for pharmaceutical waters, but that is not the only use for TOC. Many industry manufactu...

    • Language: English

  • Rockwell Automation: Flexible Manufacturing with Single Use Systems

    04/17/2018, 1:00 PM - 1:30 PM, Technical Conference Stage 5, Booth 1677, Exhibit Hall

    Biopharma companies seek innovative solutions to solve their present and future manufacturing needs. Flexible and scalable manufacturing systems incorporating m...

    • Language: English

  • Application of Rotor/GXR Technology for Development of Oral Solid Products

    04/17/2018, 1:30 PM - 2:15 PM, CMO/CDMO Theatre Booth 1053

    Rotor / GXR technology was used for development of oral solid products at CMIC CMO USA and Freund Vector, such as taste masking, drug layering, etc. This novel ...

    • Language: English

  • Process Analytical Technology and My Dosage Design Tool to Measure Functional Film Coating thickness on Multiparticulate Coating

    04/17/2018, 1:30 PM - 2:15 PM, FormulationX Stage Booth 4005

    Ethylcellulose is a widely used polymer in the formulation of modified release drug delivery systems; applications are either using organic solvent or fully for...

    • 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

  • Pharmaceutical Technology Keynote Series: Aseptic, Sterile, and Biologics Manufacturing - Analytics and Instrumentation: Best Practices for Lyophilization

    04/17/2018, 1:30 PM - 2:10 PM, INTERPHEX Innovation Stage

    In this session, experts will discuss advances in lyophilization technology, with lessons learned from academia and other industries.

    • 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

  • Pharma Intelligence: 2018 Industry Outlook

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

  • L.B. Bohle LLC: Revolutionizing truly continuous granulation and drying - QbCon®

    04/17/2018, 2:00 PM - 2:30 PM, Technical Conference Stage 5, Booth 1677, Exhibit Hall

    A completely new and innovative truly continuous drying process will be introduced to the audience. This new technology is implemented in an R&D machine for lab...

    • Language: English

  • Pharmaceutical Technology Keynote Series: Aseptic, Sterile, and Biologics Drug Manufacturing - Continuous Manufacturing for Biopharm, Visions of an End-to-End Approach

    04/17/2018, 2:15 PM - 3:00 PM, INTERPHEX Innovation Stage

    To date, the adoption of continuous manufacturing technology for bioprocessing remains slow, and where the technology is being used, it is limited to either dow...

    • Language: English

  • Biosimilars 4.0

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

  • Large Scale Single-Use Bulk Drug Substance Freeze and Thaw Platform

    04/17/2018, 2:30 PM - 3:15 PM, FormulationX Stage Booth 4005
    • Language: English

  • Considerations for Building a High Potency Manufacturing Facility

    04/17/2018, 2:30 PM - 3:15 PM, CMO/CDMO Theatre Booth 1053
    • 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

  • Sika Corp: Pharmaceutical Floor & Wall Surface Selection Guidance

    04/17/2018, 3:00 PM - 3:30 PM, Technical Conference Stage 5, Booth 1677, Exhibit Hall

    This presentation will review surface selection criteria to design a pharma production area to address ambient conditions, usage specification and lifecycle ex...

    • Language: English

  • Automated Visual Particle Inspection for Hard to Inspect Containers

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

  • Small Molecule Outsourcing Panel

    04/17/2018, 3:30 PM - 4:15 PM, CMO/CDMO Theatre Booth 1053
    • 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

  • Case studies : Steam sterilization regulatory requirements, and end user impact analysis and common mistakes.

    04/17/2018, 3:30 PM - 4:15 PM, INTERPHEX Innovation Stage

    The goal is to highlight the links between the different regulatory updates regarding steam sterilization management, validation and requalification. In particu...

    • 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

  • Antares Vision North America: Disruptive Technology for Visual Inspection of Lyophilized Pharmaceutical Products

    04/17/2018, 4:00 PM - 4:30 PM, Technical Conference Stage 5, Booth 1677, Exhibit Hall

    Introduce new technologies that provide more accurate defect detection and improve false reject rates to produce safer products for patients.

    • Language: English

  • Application of Material Selection and Compatibility in Aseptic Manufacturing

    04/17/2018, 4:15 PM - 5:00 PM, CMO/CDMO Theatre Booth 1053
    • Language: English

  • Achieving Manufacturing Efficiencies with Advanced Batch Management Technology

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

    The pharmaceutical industry's competitive environment of today demands advanced process solutions which improve manufacturing efficiency and profitability. Proc...

    • 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

  • 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

  • "Show Wrap Up Day 1"

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

  • FDA Presentation: The Future of Pharmaceutical Quality and the Path to Get There

    04/18/2018, 10:00 AM - 10:45 AM, INTERPHEX Innovation Stage

    Dr. Yu is currently the Deputy Director of the Center for Drug Evaluation and Research's (CDER) Office of Pharmaceutical Quality, Food and Drug Administration (...

    • 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

  • Rockwell Automation: FactoryTalk Analytics Project Scio: Where Information Transforms to Value

    04/18/2018, 10:30 AM - 11:00 AM, Technical Conference Stage 5, Booth 1677, Exhibit Hall

    Gaining value from production data takes time and often requires specialized expertise. Project Scio reduces these efforts by allowing any user to securely acce...

    • 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

  • 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

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