Moderator: Stefan Kohler, Director, Building Management and Infrastructure, AstraZeneca AB, E and SS

Presentations in this session will include a presentation on how LEAN principles were introduced in a short period of time to ensure the timely launch of a product. The second presentation will discuss the new technical report within PDA concerning BFS, the US FDA and EU GMP requirements.

10:45 a.m. - 11:15 a.m.
Manufacturing Excellence for an Unique Sterile Product

Thomas Schwarz, Process Unit Vials, Novartis Pharma

Moderator: Miguel Montalvo, President,
Expert Validation Consulting, Inc.

By using the principles of QbD in applying effective scientific planning, understanding the need for adequate raw materials/product characterizations and the use of accumulated product/process/method knowledge, a technology transfer step will result in a well-established manufacturing process including the analytical methods. This is specially important when working with a Contract Manufacturer. The transfer process must also be defined in a procedure to be agreed upon by all parties involved. The session will describe the application of this approach to two case studies for process/method transfer when working with contract manufacturers.

10:45 a.m. - 11:15 a.m.
Managing Knowledge and Data in an Ever Changing Environment
Herve Broly, Manager, Merck Serono

Moderator: Kurt Brorson, PhD, Biologist, CDER, FDA

This session examines how one company identified key factors that make up the most impactful activities (both positively and negatively) to their overall cost of quality and then developed and implemented a cost of quality model which helps them optimize their quality systems. The second paper presents a case study of what one organization has done to design and to implement a quality risk management system. This session ways in which an organization can significantly change how they do business while illustrating some of the challenges of implemetation of new business sytems.

10:45 a.m. - 11:15 a.m.
Utilizing a Cost of Quality Model at Genentech to Drive Quality Improvement

Theresa Friend, Senior Operational Excellence Manager, Genentech

Matthew Pearson, Associate Director, Operational Excellence, Genentech

11:15 a.m. - 11:45 a.m.
Regulatory Challenges for Blow-Fill-Seal Technology in Order to Reach Manufacturing Excellence

Stefan Sundstrom, Safety Ventilation, Safety Ventilation at The Royal Institute of Technology in Stockholm

Stefan Kohler, Director, Building Management and Infrastructure,
AstraZeneca AB, E & SS

11:15 a.m. - 11:45 a.m.
Analytical Method Transfer Strategies for a Contract Manufacturing Organization

Barbara Berglund, QC Manager, HollisterStier Laboratories

Michael Koivula, Senior Scientist, Transfer Group, HollisterSteir Laboratories

11:15 a.m. - 11:45 a.m.
Quality Risk Management for Theory to Practice: The Cangene Experience

Jeffery Hartry, Director Quality Systems and Information, Cangene Corporation

Moderator: Phil DeSantis, Senior. Director, Engineering Systems and Compliance, Merck and Company

This session presents two papers which discuss and present case studies of projects where manufacturing excellence concepts were applied as a criteria for designing, constructing, operating, and controlling modern bio-pharmaceutical facilities.

1:45 p.m. - 2:15 p.m.
Incorporating Manufacturing Excellence into Clinical Manufacturing Facility Design (Case Study: Schering-Plough Global Clinical Supply Facility)

Christian Lamont, Manager, Clinical Manufacturing, Merck and Company

Moderator: Mike Sadowski, Director, Sterile Manufacture Support, Baxter Healthcare

In 2008, FDA published a draft guidance document on Process Validation which focuses on a product life cycle approach through modern risk management that is based on a foundation of sound science supported by statistics. This session will highlight the application of critical process validation concepts over the product life cycle. Examples will be presented that detail the development of a statistically-based quality metric for process performance, that describe the use of a Design of Experiments (DOE) study in process development, and that apply PDA Technical Report No. 1 concepts to establish worst case items in the development of a variable loading pattern qualification system for moist heat sterilization.

1:45 p.m. - 2:15 p.m.
Use of Statistical Analysis in the Process Validation Lifecycle: Examples from the Stages

Scott Bozzone, Senior Manager, Pfizer, Inc.

Moderator: Miguel Montalvo, President, Expert Validation Consulting, Inc.

Operational Excellence is becoming ever more important in the pharmaceutical manufacturing world as organizations react to a changing and challenging business environment but Quality and Operational Excellence are not mutually exclusive. By applying adequate and carefully planned “lean” and automated applications to our Quality Management and Quality Control requirements, we can achieve better results and at less overall cost to our business. The session will include case studies on how companies are moving forward with these approaches to supplying a quality product at lower costs by using “lean” strategies and computerized applications.

1:45 p.m. - 2:15 p.m.
Automating Quality Processes to Achieve Operational Excellence- A Case Study

Jon Voss, Vice President, Corporate Quality Operations- Systems, Processes and New Region Development, Genzyme Corporation

Geary MacQuiddy, Project Manager, Genzyme Corporation

2:15 p.m. - 2:45 p.m.
Manufacturing IT to Support Manufacturing Excellence

Niels Anderson, Specialist, NNE Pharmaplan

2:15 p.m. - 2:45 p.m.
A Risk Based Approach to Variable Load Configuration Validation in Steam Sterilization: Application of PDA TR1 load equivalence topic

2:15 p.m. - 2:45 p.m.
The Search for Efficiencies in your QC Laboratories – The Future is Lean

Ciaran Crosbie, Operational Excellence Specialist, Pfizer, Inc

IG3 - Visual Inspection of Parenterals

The Visual Inspection of Parenterals Interest Group provides a forum to discuss topics related to the visual inspection of injectable products. Past topics have included selection and qualification of human inspectors, validation of automated inspection systems, recent regulatory activity and country specific inspection requirements. This group has also initiated activities to survey industry inspection practices, organize special meetings on visual inspection and to provide scientific guidance on compendial requirements for the inspection of injectable products.

Leaders: Scott Bozzone, Senior Manager, Pfizer

Hal Baseman, Chief Operations Officer, Valsource LLC

Moderator: Bob Dana, Senior Vice President, Regulatory Affairs and TRI PDA

Prefilled syringes are of growing importance as a drug delivery system in the biopharmaceutical industry. Different therapeutic classes have generated specific quality requirements which are addressed by the offerings available in the marketplace. The first presentation in this session will discuss why the prefilled syringe became the delivery device of choice amongst pharmaceutical professionals and how the requirements of different therapeutic classes are realized in the available drug container system offerings. Further actual regulatory requirements and their impact on prefilled syringe quality will be discussed. The second presentation highlights an innovative methodology suited to characterize the interaction of silicone oil on the surface of prefilled syringes with aqueous protein formulations which can help to minimize silicone induced quality issues in biopharmaceutics. Protein agglomeration was studied using Raman spectroscopy yielding new insights about the mechanism of protein particle formation depending on the syringe siliconization.

7:30 a.m. - 8:00 a.m.
The Prefilled Syringe: The Container of Choice for Parenteral Drug Delivery

Thomas Schoenknecht, PhD, Director Drug Product & Device Development, Amgen, Inc (Invited)

Moderator: Hal Baseman, Chief Operations Officer, Valsource LLP

This session will focus on the application of analytical methods in the measurement of key and critical parameters used in bioprocessing. Best practices in Analytical Methods Validation (AMV) as developed by a PDA Task Force will be presented, as well as a case study of two analytical methods focused on the in-line NIR spectroscopy.

7:30 a.m. - 8:00 a.m.
Quantitative Inline Measurement and Determination of 1) Content Uniformity in Suspensions and Solutions and 2) Identification of Unlabelled Bulk Using High Speed NIR Spectroscopy

Moderator: Mike Sadowski, Director, Sterile Manufacture Support, Baxter Healthcare

The use of proactive approaches is critical in the development of an effective program for microbiological control and monitoring in the pharmaceutical setting. There are many issues that are associated with conventional approaches for setting of bioburden Alert and Action limits based on upper percentiles. An alternate method that focuses on the rate of bioburden excursions above a “Threshold Limit” has been developed with the demonstrated benefit of shifting bioburden to lower levels while improving operational efficiency. Additionally, heightened awareness around microbiological control has also been shown to reduce the number of out of limits microbiological occurrences and investigations.

7:30 a.m. - 8:00 a.m.
Statistical Method for Monitoring In-Process Bioburden Levels

Irv Shiffer, PhD, Statistician, Quality Operations, Talecris Biotherapeutics, Inc.

Lisa Musmanno, PhD, Product Quality Manager, Quality Operations, Talecris Biotherapeutics, Inc.

8:00 a.m. - 8:30 a.m.
Quantification of Protein Agglomeration in Differently Siliconized Syringes

Markus Lankers, Managing Director, rap-ID Particle Systems GmbH

8:00 a.m. - 8:30 a.m.
Technical Report: Analytical Method Development

Melissa Smith, Senior Consultant, MJ Quality Solutions, LLC

8:00 a.m. - 8:30 a.m.
Bringing Microbiology Back Home

Jane Wyatt, QC Manager - Environmental Monitoring, Pfizer, Inc

Moderator: Christopher J. Smalley, Ph.D., Director, Global Compliance Operations, Pfizer, Inc

Projects intended to convey best practices throughout the organization have taken many forms over many decades throughout the Pharmaceutical Industry. Best practices are frequently defined in terms of operational efficiencies, as well as improved quality and compliance, but the ability to affect meaningful and lasting change in organizations has resulted in many approaches, such as lean, six sigma, kaizen and others, being employed. These presentations will discuss the success of lean in a CMO when properly managed by trained project managers - using a case study - and the implementation of a modular, standardization approach to production documentation in a clinical manufacturing environment. These presentations will focus not only on the best practice results achieved, but the means to achieve these results in a sustainable manner.

8:45 a.m. - 9:15 a.m.
Knowledge Management: Application of Project Management and Program Management Best Practices to Lean Manufacturing and Lean Laboratory Projects

Barbara Berglund, QC Manager, HollisterStier Laboratories

William Allen, Senior Manager, PMO, HollisterSteir Laboratories

Moderator: Felicia Ford-Rice,
Senior Director, Quality Assurance,
Formerly with Astellas Pharma Global Development, Inc.

In the current economic environment, the pharmaceutical industry is challenged to develop and manufacture products as well as to ensure stakeholder value through appropriate cost containment. These case studies will describe (1) the use of ICH guidance documents and (2) the concept of quality-by-design (QbD) to ensure price competitive product development and commercial product launch meeting quality and regulatory requirements.

8:45 a.m. - 9:15 a.m.
Implementing the FDA’s (QbD) Initiative for Cost Effective Pharmaceutical Manufacturing Quality Control and Assurance

Sandy Weinberg, PhD, Associate Professor of Healthcare, MHA, Clayton St. University

Moderator: Marsha Hardiman, Product Expert,
BSI Product Service

Implementation of Rapid Micro Methods can result in many benefits such as time and cost savings. New technologies for RMM have become available over the years. That said there is still hesitancy in the pharmaceutical industry to implement the new technologies. In this session, we will learn how to develop a return on investment model to justify the financial benefits of implementation of RMMs. Attendees will hear a review of RMM technical and business benefits and will review a case study of implementation of a RMM for Environmental Monitoring. A review of implementation of a RMM for sterility testing will also be reviewed. In this presentation, a comparison of the RMM sterility test will be made to the USP <71> method.

8:45 a.m. - 9:15 a.m.
Breaking the Rapid Microbiological Method Financial Barrier: A Case Study in RMM Return on Investment and Economic Justification

9:15 a.m. - 9:45 a.m.
Optimization of Compliance and Efficiency through Redesigning Clinical Manufacturing and Packaging Batch Records

Jessica Hunt, Manager, Clinical Manufacturing, Schering Plough Research Institute

Veronica Onumah, Manager, Clinical Packaging and Labeling, Merck and Company

9:15 a.m. - 9:45 a.m.
Quality by Design for Price Competitive Product

Eric Minguely, Development, Debiopharm Group

9:15 a.m. - 9:45 a.m.
Rapid Sterility Testing: A Comparison to USP Chapter <71> Test Methodology

Dawn McIver, President, MicroWorks, Inc.

9:45 a.m. - 10:15 a.m.
Q&A

9:45 a.m. - 10:15 a.m.
Q&A

9:45 a.m. - 10:15 a.m.
Q&A

Moderator: Ursula Busse,PhD, Head Project Office Project, Novartis Pharma AG

Disposable technologies are increasingly being used in biopharmaceutical processes owing to cost benefits, process flexibility and safety improvements. Join the session to learn about advantages and challenges inherent to existing, newest and future single-use equipment, and gain insight into strategies to streamline implementation of new bioprocess containers into a commercial manufacturing process. Several case studies will illustrate the topic and add practical information.

11:00 a.m. - 11:30 a.m.
Disposable Biopharmaceutical Processes – Advances and Benefits

Moderator: Rich Levy, PhD, Senior Vice President, Science and Regulatory Affairs, PDA

Proactive and retrospective attention to design space in product and process development will lead to higher assurance that final prducts will meet intented quality and safety charateristics. Two case studies will be presented which address development studies to identify critical parameters, set appropriate operating ranges, and ensure that the design space is optimized for fill finish operations and the lyophilization of biotech products.

11:00 a.m. - 11:30 a.m.
Characterizing and Establishing Design Space Around the Fill-Finish Unit Operations for a Biopharmaceutical Product in Support of FDP Manufacturing and Process Validation

Arpan Nayak PhD, Scientist, Human Genome Sciences Inc.

Moderator: Marsha Hardiman, Product Expert, BSI Product Service

In this session, attendees will hear about some different RMMs and how these technologies can improve efficiency. Real-time microbiological measurements present new possibilities. Results from a study showing simultaneous measurements of airborne particulates and CFUs in a test chamber for evaluation of clean room clothing systems will be presented. Pros and cons on how data from the new techniques might be connected to results from older techniques will be discussed. This session will also review challenges and requirements for development of an online bacterial endotoxin testing unit.

11:00 a.m. - 11:30 a.m.
Dectected Number of Airborne Particles and CFUs from a Test Chamber; Data Aquired from Simultaneous Measurements by IMD-A Standard OPC and STA-Sampler

Berit Reinmuller, PhD, Senior Researcher, KTH

Bengt Ljungqvist, PhD, Professor or Safety Ventilation, KTH

11:30 a.m. - 12:00 p.m.
Strategies for Implementation of a New Bioprocess Container in Commercial Biologics Manufacturing

11:30 a.m. - 12:00 p.m.
Creation of Design Space for Established Lyophilized Drug Products

Karen Bossert, VP, Scientific Affairs, Lyophilization Technology, Inc.

11:30 a.m. - 12:00 p.m.
Recent Issues in Environmental Monitoring

12:00 p.m. - 12:30 p.m.
Q&A

12:00 p.m. - 12:30 p.m.
Q&A

12:00 p.m. - 12:30 p.m.
Q&A

Moderator: Kurt Brorson, PhD, Biologist, CDER, FDA

This session addresses challenges faced when optizing upstream and downstream manufacturing processes with high titre cell culture bioreactors at industrial scale. In the first case study, scientists employed both controlled pilot-scale experimental approaches and multivariate statistical techniques to better elucidate the relationships between cell culture and purification performance. In the second case study, by evaluating development and pilot scale data, a single pass tangential flow filtration unit operation for the in-line concentration of feed streams was developed to alleviate the need to install larger intermediate product hold tanks.

2:00 p.m. - 2:30 p.m.
Redefining Upstream and Downstream Process Relationships for High-Titer Biologics Manufacturing: Application of Holistic Experimental and Advanced Modeling Approaches for Final Drug Product Quality Predictions

Moderator: Luc Pisarik, Head of Pharmaceutical Support, Merial

This session includes a case study and test data from trials performed on actual production vials. Information will be provided as to various faults which were detected with Near Infrared Technology, as well as discuss some of the practical aspects of real time release and stimulate some discussion points.

2:00 p.m. - 2:30 p.m.
Near Infrared Technology for Residual Moisture Measurement in the Cake and Laser Absorption for Oxygen Measurement in the Headspace- PAT on Freeze Dried Vials

Gerhard Schramm, Sales Director, WILCO AG

Daniel Allende, Senior Scientist II, Pfizer, Inc.

Moderator: Kristen Evans, Director, Global Quality Compliance, Amgen, Inc.

Presentations in this session will discuss The view of regulatory agencies on evaluation of the methods to demonstrate efficient mycoplasma clearance during manufacture of inactivated viral vaccines using embryonated chicken eggs, as well as, new solutions to replace Mycoplasma culture testing by PCR. The recent approval by authorities of the submitted data will support the power of the new method.

2:00 p.m. - 2:30 p.m.
Efficient Inactivation of Mycoplasmas during Production of Biologics: egg-based viral vaccines as a model

Dmitry Volokhov, Microbiologist, US FDA/CBER

2:30 p.m. - 3:00 p.m.
Viral Clearance Database

Kurt Brorson, PhD, Biologist, CDER, FDA

2:30 p.m. - 3:00 p.m.
Development of Quality Systems for Real Time Release- Practical Challenges and Opportunities

2:30 p.m. - 3:00 p.m.
Update on Mycoplasma Technical Reports

Barbara Potts, PhD, formerly with Genentech (Invited)

3:00 p.m - 3:30 p.m.
Q&A

3:00 p.m - 3:30 p.m.
Q&A

3:00 p.m - 3:30 p.m.
Q&A

IG9 - Inspection Trends/Regulatory Affairs

The Inspection Trends/Regulatory Affairs Interest Group provides a forum for sharing experiences and knowledge in the subject areas. Historically, most interest is in the area of Inspection Trends. Meeting format varies; we have panel discussions featuring industry and FDA participants, podium presentations on inspection-related activities and programs and an open forum for questions and answers relative to company experiences with government inspections. Data on current inspection findings and trends are presented, as well as discussions on new regulatory and compliance initiatives.

IG10 - Microbiology/Environmental Monitoring

The Microbiology/Environmental Monitoring Interest Group addresses topics in pharmaceutical microbiology, rapid microbiology, environmental monitoring, and compendial issues. The group typically has a guest speaker followed by a group discussion. If warranted, task forces are established to respond to issues relevant to microbiologists.  The session speaker is Dr. James Cooper, who will present on Endotoxin Contamination Control.

Endotoxin Contamination Control
James Cooper, PhD, Endotoxin Consulting Services

The Packaging Science Interest Group (PSIG) is a venue for the exchange of knowledge and ideas about pharmaceutical packaging. Members come together to develop presentations for PDA programs, organize special meetings on current topics, review USP and FDA proposals and regulations, work on task forces on focused topics, and educate each other. Meetings are held in conjunction with PDA meetings.

Glass Vial Finish Defects - Leak Detection and Product Risk Assessment
Stephen T. Orosz, Jr., PhD, Director, Fill, Finish and Packaging Process Sciences, ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company
Donna M. Guazzo, PhD, President, RxPax, LLC and Package Integrity Lab Director, Whitehouse Analytical Labs

The Facilities and Engineering Interest Group provides a forum for the discussion of topics and interests related to the design, construction, operation and maintenance of the production and research facilities used for GMP and GLP purposes. Discussions are held in conjunction with two of the PDA meetings: the Annual Meeting and the PDA/FDA Joint Conference, as well as a discussion forum on the PDA website.  The format of the Facilities and Engineering Interest Group meetings are an open forum for discussion, where attendees select the topic for discussion and the leader moderates the discussion of peers seeking to reach a better understanding of regulatory expectations and opportunities to share and learn best practices. Where appropriate, the Facilities and Engineering Interest Group will compile these understandings and best practices into technical reports with the contributions and review of interested members.

A Case Study in Utility Monitoring and Predictive Utility Management - Modular, Integrated Automation System in Large Volume Parenteral Manufacture
Robert Perks, Engineering Specialist, Baxter Healthcare Corporation

Our Continuous Journey to Operational Excellence: One Facility’s Experience
Robert Lippe, Director of Manufacturing, Genentech Vacaville Operations
Patricia Lufburrow, Senior Director and Quality Site Head, Genentech Vacaville Operations

The PDA Filtration Interest Group provides a forum for discussion of topics and issues related to filtration in pharmaceutical and biopharmaceutical applications, including sterilizing filtration of liquids and gases, depth filtration of process streams and process systems, and viral removal and purification. Discussions are held in conjunction with PDA meetings (e.g., the Annual Meeting and PDA/FDA Joint Conference) and via discussion forum on the PDA website.

The Future of Sterile Filtration in Biopharmaceutical Manufacturing: New Membrane Combinations and their Comparative Performance with Classical Membranes
Mandar Dixit, Head of Product Management, Filtration Technologies, Sartorius Stedim

Sizing of Depth Filter Capsule System
Jon Petrone, Global Technical Director, Biopharmaceuticals, Pall Life Sciences

Moderator: Rich Levy, PhD, Senior Vice President, Science and Regulatory Affairs, PDA

The quanification of sanitization and inactivation of bacteria and viruses, respectively, in biotech and plasma products will be explored. Assay methods will be decribed and results discussed in support of the use of two very different microbial control methods in two very different applications.

7:30 a.m. - 8:00 a.m.
Effective virus inactivation in human plasma by UVC irradiation without altering plasma protein activity

Eckard Flechsig, PhD, Head of Virus Validation, Biotest

Moderator: Hal Baseman, Chief Operations Officer, Valsource LLP

This session will include a review of risk management uses in the industry and am Update on the Technical Report R44 revision.

7:30 a.m. - 8:00 a.m.
Risk Management Techniques for Pharmaceutical Manufacturing

Mike Long, Director of Engineering, Cooper Surgical

Moderator: Kurt Brorson, PhD, Biologist, CDER, FDA

This session will be based on the new PDA Technical Report which addresses principles important to Endotoxins. This session will also review challenges and requirements for development of an online bacterial endotoxin testing unit.

8:00 a.m. - 9:00 a.m.
Chicken Egg Vaccine Injector Manufacturing: A Bioluminescence-based Assay to Monitor Effectiveness of Instrument Sanitization After Microbial Challenge Procedure

Claudio Denoya, Microbiological Technical Assessment (MTA) Lab, Pfizer Global Research & Development

8:00 a.m. - 8:30 a.m.
PCMO Updates

Jeffrey Hartman, Validation Manager, Merck & Co., Inc.

7:30 a.m. - 8:00 a.m.
Endotoxin Interest Group Updates

Luc Pisarik, Head of Pharmaceutical Support, Merial
Guy Roehrig, Lead Scientist, Eli Lilly France SA
Christophe Grimm, Global Key Account Executive, Sartorius Stedim Biotech GmbH

8:00 a.m. - 8:30 a.m.
Development of an Online Endotoxin Testing System

Jeffery Weber, Senior Scientist- PAT Projects, Pfizer

Moderator: Felicia Ford-Rice,
Formerly with Astellas Pharma Global Development, Inc.

The pharmaceutical manufacturing process can be negatively impacted by risk and variability, resulting in nonconforming product. Industry and regulators have a vested interest in ensuring application of quality risk management principles during process development and product manufacturing. These case studies will (1) demonstrate the application of a risk assessment tool based upon ICH Q9 principles in R&D environment for biologics and (2) demonstrate the use of yield reconciliation, for both API and finished goods, as a managerial tool for risk mitigation and process control. This session will explore the benefits of partnering between Manufacturing, Quality, and R&D to gather useful data and, through appropriate analysis to translate that data into useable knowledge to reduce both risk and product variability. The case studies will help demonstrate how effective partnership can be the best approach for success in product development (R&D) and product manufacturing (commercial). The value of this approach in achieving successful (on time/on budget) product development (R&D) and manufacturing will be addressed.

8:45 a.m. - 9:15 a.m.
Case Study: Implementation of a Scientific Risk-Based Materials Clearance Program for Biological Product Development Projects

Moderator: Christopher J. Smalley, Ph.D., Director, Global Compliance Operations, Pfizer, Inc

The critical application of process design has been addressed to process chromatography by the two presentations in this session. The first presentation will review the application of mechanistic chromatographic modeling to simulate and optimize the actual commercial scale operation, a great example of Design Space. These methods are shown to predict pressure drops in columns to estimate the maximum operating flow rate and bed height. The second presentation is a case study where a sterilizable chromatography system was developed for a large live virus, which again uses a Design Space for the closed aseptic process. From proof of concept through the design, evaluation of sterilization methods, validation and the re-validation strategy, this presentation will be certain to command your interest.

8:45 a.m. - 9:15 a.m.
Creating a Chromatography Design Space Using Mechanistic Modeling Techniques

Peter Watler, Chief Technical Officer, Hyde Engineering and Consulting

Moderator: Marsha Hardiman, Product Expert,
BSI Product Services

Media fill tests are critical for the validation and control of aseptic processes. Current practices require visual inspection of thousands of containers filled with media. This involves considerable time resources and highly qualified technicians. In this session, attendees will hear an update on the status of TR22, XXXX. A review of a case study using a new MFT culture medium that allows for detection of contamination with an irreversible color change will be presented, including the benefits that can be gained such as reductions in reading errors.

8:45 a.m. - 9:15 a.m.
TR 22 - Aseptic Process Simulation and Aseptic Process Evaluation and Control
Hal Baseman, Chief Operations Officer, Valsource LLC

9:15 a.m. - 9:45 a.m.
Process Yields- A Tool for Continuous Improvement

9:15 a.m. - 9:45 a.m.
Case Study- Sterile Packed Bed Chromatography

Ernst Braendli, Sr. Scientist, Sanofi Pasteur
Raf Lemmens, PhD, Global Fast Trak Leader, GE Healthcare

9:15 a.m. - 9:45 a.m.
Media Fill Tests Readings Made Easier

9:45 a.m. - 10:15 a.m.
Q&A