B – Electronic Manufacturing Records

C – Automating Quality Systems I

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

Moderator: Ian Elvins, Vice President, Quality, Lonza Biologics and Chair,
2009 PDA Annual Meeting Program Planning Committee

Moderator: Ursula Busse, PhD,
Head of Project Office, Novartis

This session will highlight aseptic manufacturing processes which incorporate the latest automation technologies designed to improve product quality. The manufacturing of syringes and vials, as well as blow-fill-seal containers, will be discussed

Fully electronic records have long been a highly desirable goal within the industry, but it is only now that technology has advanced sufficiently to make this a realizable possibility. In this session, you will hear two case studies describing the practical application of electronic batch records in the manufacturing environment. You will see how electronic records can improve both compliance and efficiency. Once records are electronic, considerable new possibilities open up in terms of collating and organizing them, allowing better scrutiny and control, as well as facilitating batch release. Our third speaker addresses the topic of the electronic management of records.

Computerized systems are central to the establishment of efficient, uniform and yet flexible corporate quality systems in today’s global environment. Case studies will illustrate approaches to building technology enabled quality systems, adapting them to a company’s changing needs as it transitions from development to commercialization, and replacing old site-specific legacy systems by new corporate quality systems across multi-site facilities. All of this in line with ICH Q10.

10:45 a.m. - 11:15 a.m.
A Strategy to Design New Automated Production Lines for Pre-fillable Syringes
Thomas Virot, Manager, WW Engineering, BD Pharmaceutical Systems

10:45 a.m. - 11:15 a.m.
Use of a Manufacturing Execution System (MES) in a Biotech Cell Culture Facility
Norbert Hentschel, Director, Compliance and Validation, Boehringer Ingelheim Pharma GmbH & Co KG

10:45 a.m. - 11:15 a.m.
A Case Study in Managing Quality System Information While Transitioning from R&D to Commercial Manufacturing
Regina Grochowski, Senior Manager, QA Compliance, Human Genome Sciences, Inc

11:15 a.m. - 11:45 a.m.
Isolated Vision-Guided Robotic Filling of Vials and Syringes
Christopher Procyshyn, Director, CMC, VanRx Inc.

11:15 a.m. - 11:45 a.m.
Driving Quality Excellence Using Electronic Batch Recording: How Automation Can Support Your Quality Improvement Programs
Marc Puich, Vice President, MES Program Management, Werum America

11:15 a.m. - 11:45 a.m.
Multi-Site Quality System Deployment in the Biopharmaceutical Industry
Anders Vinther, Senior Director, Corporate Quality System and Support, Genentech

11:45 a.m. - 12:15 p.m.
Advanced Aseptic Processing, Blow-Fill-Seal Automation and Beyond
Mattias Haag,  Project Manager, EnergoRetea AB

11:45 a.m. - 12:15 p.m.
Electronic Document Management in Pharmaceutical Production
Niels Andersen, Manufacturing IT,
NNE Pharmaplan

11:45 a.m. - 12:15 p.m.
Creating Consistent Quality with Technology Implementation
George Kuniholm, Executive Director, Quality Systems, Anika Therapeutics

12:15 p.m. - 12:30 p.m.
Q&A

12:15 p.m. - 12:30 p.m.
Q&A

12:15 p.m. - 12:30 p.m.
Q&A

E – Computers and Process Development

F – Automating Quality Systems II

Moderator: Stefan Kohler, Director, Building Management and Infrastructure, AstraZeneca

Moderator: Ursula Busse, PhD,
Head of Project Office, Novartis

Moderator: Jennie Allewell, Sr. Director, Business Process Excellence, Sales and Business Development, Lonza, Inc.

The use of advanced computer software and mathematical models to optimize or study the impact of different process settings is becoming a more common approach. This session will provide information about new and developing technologies for Process Control and demonstrate how to use Computational Fluid Dynamics together with Risk Methods, such as the LR method in order to predict and study particle dispersion routes in the aseptic core of an highly automated process. A discussion on how EU regulatory agencies interpret the European GMPs with respect to the increasing automation used within aseptic processing, both from a design philosophy and from an inspection point of view, will also be covered. The purpose of this session is to discuss how regulators and industry can be more aligned regarding the regulation of new technologies and high-level automation.

Learn how computer modeling can effectively replace trial and error approaches in drug development. Automated parameter screening has found many different applications, such as bioprocess development, formulation optimization and the establishment of product shelf life. Discover how the assessment of multiple variables in parallel can increase the quality and the speed of drug development.

The automation of quality systems is now a must if we are to effectively track and control compliance. In this session, you will hear not only practical advice on how to select and interlink automation tools, but also a review of configurable systems and how these offer a cost effective way to automate quality systems. The third speaker offers an interesting case study on how automation can even be applied to auditing.

2:00 p.m. - 2:30 p.m.
In-line Control of a Lyophilization Process Based on Product Temperature Soft-Observer
Miquel Galan, Director of Innovation, R&D, Telstar Lyo

2:00 p.m. - 2:45 p.m.
Fully Automated 32 Stirred-Tank Bioreactor System for High Throughput QbD-based Bioprocess Development
Martin Rhiel, Fellow, BioProcess Development, Novartis Biologics

2:00 p.m. - 2:30 p.m.
Applying an Analytical Approach to the Quality Systems Vendor Selection Process
Marie McDonald, Senior Manager,
Clarkston Consulting

2:30 p.m. - 3:00 p.m.
Optimizing an Highly Automated Process with the LR Method and Computational Fluid Dynamics (CFD)
Stefan Kohler, Director, Sterile Aseptic Manufacturing, Engineering and Maintenence, AstraZeneca
Stefan Sundström,PhD, Senior Engineer, AstraZeneca

2:45 p.m. - 3:30 p.m.
The Development and Use of Stability Models in Predicting Drug Characteristics at the End of Shelf Life
Peter Sprinz, Research Scientist, Eli Lilly and Company

2:30 p.m. - 3:00 p.m.
Implementing Configurable Process Management Software for Quality Systems
Eric Salwan, Information Technologies Consultant, CompuSolve Ohio, Inc.

3:00 p.m. - 3:30 p.m.
EU Regulatory Perspective on Automation in Aseptic Processing
Martyn Becker, Managing Director, Martyn Becker Associates

3:00 p.m. - 3:30 p.m.
Applying a Risk Management Approach to Auditing via Use of Risk Tools and Trend Metrics
Richard Spehar, Associate Director, Computerized Systems and Instruments, QA, Johnson & Johnson

3:30 p.m. - 3:45 p.m.
Q&A

3:30 p.m. - 3:45 p.m.
Q&A

3:30 p.m. - 3:45 p.m.
Q&A

IG2 - Combination Products

IG3 – Facilities and Engineering

IG4 - Vaccines

IG5- Lyophilization

Leader: Jeanne Moldenhauer, PhD, Vice President, Excellent Pharma Consulting

Leader: Michael Gross, PhD, Principal Consultant, Chimera Consulting

Leader: Chris Smalley, Director, Compliance Operations, Wyeth Pharmaceuticals

Leader: Frank Kohn, PhD
President, FSK Associates, Inc.

Leader: Edward Trappler, President, Lyophilization Technology, Inc.

The Microbiology/Environmental Monitoring Interest Group will have a panel discussion on the topic of contamination investigations. Speakers for this panel include James Akers, PHD, who is a microbiology expert at USP, and Kenneth Muhvich, PhD, a former FDA microbiology reviewer. Speakers will provide short presentations and then open up the discussion to attendees.

This PDA Interest Group provides a forum for discussion of topical issues concerning submissions and compliance matters related to a variety of combination product types with emphasis on drug delivery devices and functional pharmaceutical packaging. This session will include open discussions of hot topics and formal presentations by industry and government experts on a variety of topical combination product quality and regulatory issues.

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.
This session will provide 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.

The Vaccines Interest Group focuses on issues that affect the biological, biotechnology and vaccine industry. The interest group has previously discussed regulatory issues, new technologies, and emerging industry trends. Resent issues include vaccine availability and supplies, homeland security and inspection trends.

As a constantly developing field there are always new perspectives in the science, technology and compliance realms. This interest group provides an open forum for discussions on current topics. Topics are identified at the onset of the meeting for open discussions among participants. This provides a unique opportunity to learn from a variety of experiences and perspectives and provides an excellent benchmark for current industry practices.

“Sterility Failures caused by Propionibacterium acnes”
Ken Muhvich, PhD, Principal Consultant, Micro-Reliance LLC

James Akers, PhD, President,
Akers, Kennedy & Associates

Karen Ginsbury, CEO, PCI Pharmaceutical

H – Training

I - Quality Improvement

Moderator: Hal Baseman, Chief Operations Officer, Valsource LLP

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

Moderator: Felicia Ford-Rice,
Senior Director, QA, Astellas Pharma US, Inc.

This session will explore two innovative approaches to sterile product manufacturing, emphasizing contamination control and reduction of personnel intervention.

This session will focus on the use of Learning Management Systems and computer-based training and how thesecan be designed and utilized to train quality science personnel. The session will also provide you with presentations onhow one organization integrated a Learning Management System into theirquality system. You will hear real life examples from company representatives about how they designed and utilized computer-based programs to develop and implement training and education systems.

This session will feature presentations that describes the concept, development and successful implementation of a Manufacturing Tracking System (MTS) which virtually eliminates all human error from the manufacture of terminally sterilized large volume parenterals (LVPs), along with a discussion on the need to document and provide evidence of training has been a critical (yet elusive) quality system component for any company involved in the pharmaceutical industry.

7:00 a.m. - 7:30 a.m.
Case Study on the Selection, Design, Installation and Validation of an Aseptic Isolated Pre-filled Tub Syringe Filling Line Utilizing eBeam Tub Decontamination
Chris V. Stenglin, Metall-Plastic

7:00 a.m. - 7:30 a.m.
Training Made Simple: Integrating a Learning Management System Into a Quality Systems Approach
David Talmage, Training Manager, Bayer Healthcare

7:00 a.m. - 7:30 a.m.
A Case Study in Human Error Reduction - Modular, Integrated Automation System in Large Volume Parenteral Manufacture
Robert Perks, Manager of Operations Support, Baxter Healthcare Corporation

7:30 a.m. - 8:00 a.m.
Closed Vial Technology: New Development for Lyophilized Products
Jacques Verhees, Area Sales Director, Aseptic Technologies

7:30 a.m. - 8:00 a.m.
Using a Three-tiered Computer-based Training System for Reporting Deviations in Pharmaceutical Manufacturing Operations
Matthew Jones, Quality Science Systems,
Ben Venue Laboratories

K - Practical Data Utilization

L – Environmental Monitoring

Moderator: Ian Elvins, Vice President, Quality, Lonza Biologics and Chair,
2009 PDA Annual Meeting Program Planning Committee

Moderator: Ursula Busse, PhD,
Head of Project Office, Novartis

Moderator: Marsha Hardiman,
Product Expert, BSI Product Services

Automation is having an ever increasing impact on the way we design and operate manufacturing plants. Hear from GSK on the successful start-up of an automated biopharma facility, and how a risk-based approach and the leveraging of the control system architecture enabled reduced testing and a compliant result. In addition, the second speaker will address the advantages of modular construction and how this will enable an “island of automation” approach to be realized. The third speaker will present a case study on the wider issues of how to control and coordinate the operation of a modern biopharma production facility with the aim of enabling fast and compliant release of product through paperless systems.

Today’s pharmaceutical manufacturing environment heavily relies on the use of automation and electronic data collection. This session will illustrate how process data can be retrieved into customized database applications and used, in combination with statistical tools, to quickly monitor process performance or reliably predict potential deviations. Automated electronic data collection and analysis are the basis for the gain in technical information and process knowledge.

Innovative technologies are now available to effectively leverage the ability to assess environmental monitoring results instantly help us better manage EM data. In this session, you will hear three different cases studies demonstrating the use of new EM sampling and data management technologies. Learn about the benefits that these advances in technology can bring to your facility. The first speaker will address how software can be used to assess low-level and non-zero data trends to allow for a more efficient reaction when a trend occurs. The second case study will address the benefits of implementation of a paperless EM data capture system including reductions in lead times and elimination of non-value added activities. The third speaker will present case study results of using a real-time viable and nonviable EM instrument during an aseptic filling operation in a manufacturing isolator. This new technology allows for instantaneous assessment of environmental changes which can result in a better understanding of microbiological control during manufacturing

8:00 a.m. - 8:30 a.m.
An Integrated Risk- and Science-based Approach to Qualifying a Fast-Tracked Automated Biopharmaceutical Facility
Scott Runkle, Senior Validation Engineer, GlaxoSmithKline

8:00 a.m. - 8:30 a.m.
Statistical Process Control: Cusum Control Charts Theory and Examples of Use in the Manufacturing Environment
Stephan Roenninger, Dr.–Ing., Global Quality, F.Hoffmann-La Roche Ltd.

8:00 a.m. - 8:30 a.m.
A Novel Approach to Addressing Low Level Trends and Non Zero Results
Robert Lutskus, Supervisior, QCMLS,
ImClone Systems

8:30 a.m. - 9:00 a.m.
The Role of Automation and Computerized Systems in Modern Modular Manufacturing Facilities of the Future
Peter Watler, Chief Technology Office, Hyde Engineering and Consulting

8:30 a.m. - 9:00 a.m.
Automation and Data Handling in Filter Integrity Test Systems
Will Clark, Instrumentation Technology Group, Pall Corporation

8:30 a.m. - 9:00 a.m.
Improvement in QC Environmental Monitoring Processes by Implementation of a Paperless Data Capture System
Tim Coleman, Senior Director, QC Testing Services, Lonza Bioscience

9:00 a.m. - 9:30 a.m.
Implementation Of A Process Automation System In A New Pharmaceutical Manufacturing Facility
Joseph A Masi, Senior Director, Manufacturing, MannKind Corporation

9:00 a.m. - 9:30 a.m.
Customized Database and Analytical Applications for Biologics Manufacturing
James McAllister, Senior Statistician, Applied Statistics, Lonza Biologics

9:00 a.m. - 9:30 a.m.
Case Studies in the Use of the BioVigilant IMD-A for Real-time Environmental Monitoring During Aseptic Filling, Intervention Assessments and Glove Integrity Testing in Manufacturing Isolators
Michael Miller, PhD, Senior Research Fellow, Manufacturing Science and Technology, Eli Lilly and Company

9:30 a.m. - 10:00 a.m.
Q&A

9:30 a.m. - 10:00 a.m.
Q&A

9:30 a.m. - 10:00 a.m.
Q&A

N – Trending and Traceability

O – Rapid Microbiology Methods

Moderator: John Shabushnig, PhD, Senior Manager/Team Leader, Pfizer, Inc, and Chair, PDA Board of Directors

Moderator: Bob Dana, Vice President, Quality and Regulatory Affairs, PDA

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

The detection and identification of foreign material in finished units of an injectable product is an important part of the manufacturing process.100% inspectionis necessary forthe detection and removal of very low levels of visually detectable defects. Identification offers an important tool to find the root cause and reduce the rate of similar defects in subsequent batches. This session will include presentations on new technologies to aid in both detection and identification of foreign material.

Computerized systems have been used in many different ways to improve the efficiency of handling data and modeling new approaches using that data. In this session, presentations will address new and novel applications of data collection and analysis, as well as discussing how information technology can be used to improve the efficiency and effectiveness of managing the validation lifecycle. Finally, the use of computerized risk modeling and simulation to reduce patient risk by optimizing drug delivery systems from manufacture to administration will be described.

Microbial detection and identification methods have benefitted from the incorporation of detection systems, microprocessors and robotics. This session will explore recent advances in automation technology which has enabled us to screen, enumerate and process samples quickly and more accurately.

11:00 a.m. - 11:30 a.m.
Optimizing the Correlation of Automated Inspection Data Obtained from Electronic Sensors to (NIST Traceable) Referee Level Particle Standards
Gerald Budd, Founder/President, Phoenix Imaging Ltd.

11:00 a.m. - 11:30 a.m.
Automated Time-Trending Tool for Improved Quality Assurance
May Suet-Mui Tang, Director, May Consulting Services Inc.

11:00 a.m. - 11:30 a.m.
Evaluations of a Novel Technology for the Automated Rapid Enumeration of Microorganisms
John A. Williams, Manager Research, Baxter Healthcare Corporation

11:30 a.m. - 12:00 p.m.
Automated Raman and Computer Controlled SEM: Streamlining Identification of Foreign Particulate Matter in Pharmaceutical Samples
Karen Sutch, Project Manager, Pharmaceutical and Biotechnology Services, RJ Lee Group

11:30 a.m. - 12:00 p.m.
Quantitative Risk Modeling and Simulation of Parenteral Products Reduces Patient Risks
Ed Tidswell, Director of Sterility Assurance, Baxter Healthcare

11:30 a.m. - 12:00 p.m.
Design and Development of a High-Throughput Platform for Rapid Microbe Identification and Automatic Data Management
Björn Breth, PhD, Scientist, Greiner Bio-One GmbH

12:00 p.m. - 12:30 p.m.
Evaluation of Automated Visual Inspection Technologies for Biologic Products
Sean Deng, Drug Product and Device Development, Amgen Inc.

12:00 p.m. - 12:30 p.m.
Implementing Electronic Systems to Identify Bioprocess Containers and Monitor Batch-Related, Critical Item-Level Data from Manufacture to the End User
Jeff Johnson, Director of Software Solutions, AdvantaPure / NewAge Industries

Gael Peron, Global Product Manager, Fluid Management Technologies, Sartorius Stedim Biotech
 

12:00 p.m. - 12:30 p.m.
High Throughput and Automation in the Development of a Nucleic Acid Amplification based Rapid Microbiological Method (RMM) for the Detection and Enumeration of Microbial Contaminants in Pharmaceutical Samples
Claudio Denoya, Group Leader, Microbiological Technical Assessment Group, Pfizer Global Research & Development

12:30 p.m. - 12:45 p.m.
Q&A

12:30 p.m. - 12:45 p.m.
Q&A

12:30 p.m. - 12:45 p.m.
Q&A

Q – Practical Validation

R – Towards the Electronic Laboratory

Moderator: Maurice Phelan, Director, Regulatory Affairs, Millipore Corporation

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

Moderator: Beverly McCalla, Senior Director, Quality Control, Gen-Probe

A case study will be presented on computerized systems to proactively control microbial contamination during aseptic processing. This session will also describe the use of in-line sensors to understand variability in a process making a solid dosage matrix; provide examples of the tools linked to DoE’s being used to understand how the process maybe manipulated and provide an example of a model predictive control strategies for using this new type of information to perform mid course corrections to force a process down a defined trajectory.

The application of new technologies such as PAT and well designed automated control systems have made it possible to optimize our separation processes and provide a higher assurance of meeting our product specifications without additional testing or validation data. The session will describe the current industry perspective on the practical approach to the validation of separation technologies, including column chromatography and tangentlal flow filtration and how the implementation of these advanced automated systems can provide the basis to eliminate the need to validate the re-use of columns resins and filtration membranes. This approach includes the incorporation of computer modeling, PAT and Forward Processing Criteria (FPC) to enable release of membranes prior to re-use, thus minimizing the burden of re-use validation.

The use of Electronic Laboratory Notebook (ELN) technology is expanding throughout the industry. As the paper measurement systems are replaced by advanced monitoring and electronic data base systems, there has been a proliferation in the amount of data generated and collected. In addition to the benefits provided, many opportunities to introduce problems, inefficiencies and analyst frustrations exist. This session will discuss the application of Good Informatics Practices (GIP) to ELN using a risk-based guidance, leveraging quality and informatics best practices. In addition, a case study for implementing an effective approach for a paperless laboratory will be presented. Routine monitoring using a cost-effective method for Statistical Process Control (SPC) linking the laboratory information management system (LIMS) to a visually-oriented statistical software package (SAS JMP) will also be discussed via a case study

1:45 p.m. - 2:30 p.m.
Advanced Control Systems to Improve Efficiency of Pharmaceutical Manufacturing Processes
Stephen Hammond, Director, Process Analytical Support Group, Pfizer, Inc

1:45 p.m. - 2:15 p.m.
Computerized Systems and Automation Advances to Eliminate Validation of Column and Membrane Re-use
Peter Watler, Chief Technical Officer,
Hyde Engineering and Consulting

1:45 p.m. - 2:15 p.m.
Electronic Laboratory: Moving Beyond
Paper, Pens and People
Adam Mott, Quality Control, Lonza Biologics

2:30 p.m. - 3:15 p.m.
Process Analytical Technology (PAT) for Monitoring Conjugation of Cytotoxic Agents to Modified Antibodies; Applications to Immunoconjugate Process Development, Scale Up and Automated Process Control
Ian Schwartz, Process Development Engineer, ImmunoGen

2:15 p.m. - 2:45 p.m.
PDA Technical Report No. 14,
Validation of Column-based Chromatography Processes for the Purification of Proteins
Norbert Hentschel, ABP Quality & Compliance, Boehringer Ingelheim Pharma GmbH & Co. KG

2:15 p.m. - 2:45 p.m.
Case Study: A Practical Approach to Data Extraction From a LIMS System with the Application of Statistical Process Control (SPC)
Greg Flexman, Process and Risk Analysis, Talecris

2:45 p.m. - 3:15 p.m.
Analytical Methods Validation of BioTech Products - Risk Based Validation
Stephan O. Krause, PhD, Director of Quality, Mpex Pharmaceuticals, Inc.

2:45 p.m. - 3:15 p.m.
New Cures for Chronic Software and System Interoperability Challenges
William S. Harten, President, CTO, UNIConnect

3:15 p.m. - 3:30 p.m.
Q&A

3:15 p.m. - 3:30 p.m.
Q&A

3:15 p.m. - 3:30 p.m.
Q&A

IG7 - Process Validation

IG8 - Visual Inspection of Parenterals

IG9 - Filtration

IG10 - Packaging Science

IG11 –Quality Risk Management

Leader: Richard Johnson, QA/QC Consultant

Leaders: Hal Baseman, Chief Operations Officer, Valsource LLP

Mark P. Roache, Director of Validation, Quality Assurance, Bayer Healthcare

Leader:
John Shabushnig, PhD, Senior Manager/Team Leader, Pfizer, Inc and Chair, PDA Board of Directors

Leader: Russell Madsen, President, The Williamsburg Group, LLC

Leader: Ed Smith, PhD, Principal Consultant, Packaging Science Resources

Leader: Jeff Hartman, Validation Manager, Merck & Co

The Sterile Processing Interest Group offers an overview of the relevant practical aspects of developing and processing pre-filled syringes with a focus on process steps such as siliconization, filling, stoppering and visual inspection. You will learn about the relevant methods for in-process controls and functionality testing of syringes, including silicon oil determination and distribution in the syringe, friction force measurements and particulates determination.

This interest group provides a forum for presenting and discussing issues and trends in validation. These discussions result in a better understanding of PDA member needs. This, in turn, results in better programs, more useful publications and appropriate areas of advocacy.

The Visual Inspection of Parenterals Interest Group provides a forum to discuss topics related to the visual inspection of injectable products. Past topics of discussion have included the 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.

The biopharmaceutical industry is moving toward the standard use of Parvovirus filters in their manufacturing processes. Virus filter validation is an important, but often overlooked, part of successfully implementing these filters. Strict adherence to the current practice (initial spike of virus, “SPIKErun” and designing to the achieved L/m2) can lead to oversized installed designs. The implementation of new methods to be discussed will allow for optimized process economics, thereby, reducing the cost of goods for the virus filtration step.

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.

The newly-formed Quality Risk Management Interest Group will address current thinking in risk management and case studies that illustrate how risk management is being implemented within the pharmaceutical and biopharmaceutical industry. Don't miss this opportunity to help chart the direction for this new PDA Interest group.

Alternative Virus Filter Validation Strategies: A Little Extra Effort During Validation Yields a Minimum Cost of Goods for the Life of Your Process
Paul Genest, Consulting Engineer, Millipore Corporation

Advancing Thermal Package Design by Combining Modern Technologies
Kevin O'Donnell, Director and Chief Technical Advisor, Tegrant Corporation,
ThermoSafe Brands

Container Closure Integrity by Design, Modeling and Testing
Mihaela Simianu, PhD, Manufacturing Science and Technology, Eli Lilly & Co.  

The Measurement of Vial Seal Integrity
Roger Asselta, Vice President of Technical Affairs
Genesis Packaging Technologies

IG13 - Inspection Trends/Regulatory Affairs 

IG14 - Pre-filled Syringes

IG15 - Pharmaceutical Water

Leader:
Kathleen Greene, Executive Director, Novartis Pharmaceuticals

Leader: Bob Dana, Vice President, Quality and Regulatory Affairs, PDA

Leader:
Thomas Schoenknecht, PhD, Director Drug Product and Device Development, Amgen, Inc.

Leader: Theodore H. Meltzer, PhD, Capitola Consulting Co.

The Clinical Trial Materials Interest Group offers the opportunity to discuss topics of interest associated with the development and manufacture of clinical supplies. This includes the pre-clinical phase, the manufacture of all phases of clinical supplies, and the ultimate transfer of the manufacturing process to the commercial manufacturing site.
This group offers a valuable opportunity to interact with professionals and regulators alike to share ideas, discuss opinions, and offer advice to each other in this very complex area of the pharmaceutical business.

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.

The Pre-filled Syringes Interest Group provides a forum for discussions of actual topics related to pre-fillable injection system components, such as cartridges or syringes and combinations thereof with injection and safety devices. Members come together to exchange the latest information about technological improvements in the universe of pre-fillable syringes and injection devices, covering production, filling, handling and regulatory aspects. The format of the Interest Group meetings includes formal presentations of experts from industry and government, as well as open discussions.

The PDA Pharmaceutical Water Task Force has undertaken a subcommittee approach to establishing the state of knowledge concerning certain important but unresolved topics. These are:

• Rouging and Passivation of Austenitic Steels
• Biofilms, Origins, and Management
• Sampling - Where, When, How in Europe, Japan and the United States

The Quality Systems Interest Group will consider the following two topics during this meeting:

1) Implementation of ICH Q10 with a focus on how Knowledge Management may be defined and used and

2) Different approaches to controlled printing and where is the added value of this requirement? Join invited industry and FDA speakers and new Interest Group Leader Anders Vinther for what is sure to be a stimulating and interesting session.

Edward Trappler, President, Lyophilization Technology, Inc.

EMEA’s paper on reverse osmosis
Russell Madsen, President, The Williamsburg Group, LLC

Moderator: Don Elinski, Senior Associate, Lachman Consultant Services, Inc 

Moderator: Hal Baseman, Chief Operations Officer, Valsource LLP

Lean manufacturing is built not only on automation, but also the ability to effectively link the many different automated functions together. This session will seek to answer how this may be achieved in a cost effective way, and key to this is the vendor selection process.

This session will present an update of two important PDA Technical Report revision efforts that focus on aseptic process control, monitoring and validation.

8:00 a.m. - 8:30 a.m.
Automating for Lean Benefits
Nikki Willett, Vice President, Marketing and Regulatory Affairs, Pilgrim Software, Inc.

8:00 a.m. - 8:30 a.m.
Update on PDA Technical Report No. 13, Fundamentals of an Environmental Monitoring Program
Jeanne Moldenhauer, PhD, Vice President, Excellent Pharma Consulting

8:30 a.m. - 8:45 a.m.
Q&A

8:30 a.m. - 9:00 a.m.
Update on PDA Technical Report No. 22,  Process Simulation Testing for Aseptically Filled Products
Hal Baseman, Chief Operations Officer, Valsource LLP

W – Novel Microbiological Approaches

Moderator: Jean Bender, Senior Engineer, Genentech, Inc.

Moderator: Felicia Ford-Rice, Senior Director, Quality Assurance, Astellas Pharma US, Inc.

Moderator: Marsha Hardiman,
Product Expert, BSI Product Services

Automated systems in current manufacturing facilities support a diverse number of functions including process control, data acquisition, equipment cleaning and sanitization and recording manual inputs. Manufacturing operations rely on these systems to ensure reproducibility and maintaining validated production ranges. This session will feature presentations about the role of automation in CIP/SIP systems, integration of several outdated automation systems into a single streamlined application and linking automated tools to enable a process to monitor and control its performance with minimal human intervention. The presentation on CIP/SIP is a case study that will address practical design and validation concerns and present PAT opportunities for computerized CIP/SIP systems. The second presentation will describe how legacy automated systems may be integrated into a single enterprise enabling increased productivity and cost-savings. Finally, the third presentation features a controller, analyzer and sampling tool connected via automation to monitor and control a process, initiate sampling and data analysis when a parameter was detected to be out of range and enable self-correction of that parameter.

This session will features a case study intended to guide you through the process of a successful validation project of a large computer system (e.g., SAP), including lessons learned and allow you to discuss different tracking approaches for large validation projects. In addition, the session will include a presentation that examines a multi-site harmonized approach to integrating Quality Risk Management in the validation lifecycle of production and laboratory equipment, facilities, utilities, computer and control systems (referred to as “systems”).

The usefulness and potential benefits of using rapid microbiology technologies and methods are vast. The ability to understand microbiological results quickly during production is becoming increasingly important in the pharmaceutical industry. Rapid Micro Methods (RMM) allow for a reduced time for results which helps to improve the efficiency of manufacturing processes. This session will provide you with an update on changes to PDA Technical Report No. 33 as well as present two case studies of RMM. Limit of Detection (LOD) is essential information needed when a conventional method is being replaced by an alternative method. You will learn about a novel approach to determining the LOD of a qualitative rapid method. A case study on the implementation of a rapid sterility test including benefits and challenges experienced will also be presented.

9:00 a.m. - 9:30 a.m.
Clean-In-Place (CIP) and Sterilize-In-Place (SIP) Systems in the Biopharmaceutical Industry, Improving Process Reliability Through Computerization
Charles Lankford, Chief Executive Officer/Co-founder, PharmaSys, Inc.

9:00 a.m. - 9:30 a.m.
Automated Validation Information Management System Case Study
Andrew Haney, Systems Manager, Engineering Software Solutions, ValSource LLC

9:00 a.m. - 9:30 a.m.
Update on PDA Technical Report No. 33 Michael Miller, PhD, Senior Research Fellow, Manufacturing Science & Technology, Eli Lilly and Company

9:30 a.m. - 10:00 a.m.
Gaining Efficiency and Agility Though Normalization of Disparate Islands of Automation
James Lysaght, Director, Compliance Services, Invensys Process Systems

9:30 a.m. - 10:00 a.m.
Large ERP Validation Projects and Effective Traceability
R. Jurgen Schmerler, CEO, Deep Sky Reliance Solutions

9:30 a.m. - 10:00 a.m.
A Novel Approach for Determination of the limit of Detection (LOD) of a Microbiological Quantitative Method
Geert Verdonk, Microbiology ControlLab
Section Leader, Schering-Plough Corporation

10:00 a.m. - 10:30 a.m.
Utilization of a Controller Interconnected to a Chemical Analyzer and Automated Sampling System to Optimize Bioprocess Management
Larry West, Chief Executive Officer, Nereus Consulting LLC

10:00 a.m. - 10:30 a.m.
A Harmonized Risk -based Validation Approach for Manufacturing and Computer Systems: Case Studies
Emma Ramnarine, Senior Manager, Corporate Quality System and Support, Genentech

10:00 a.m. - 10:30 a.m.
Implementation of Rapid Sterility Testing - A Case Study
Gary Gressett, Director, Corporate QA Technical Services, Alcon Laboratories Inc.

10:30 a.m. - 10:45 a.m.
Q&A

10:30 a.m. - 10:45 a.m.
Q&A

10:30 a.m. - 10:45 a.m.
Q&A