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CONTAINER CLOSURE SYSTEMS 2010 Strategies for Selection, Compliance, and Mitigation of Extractables and Leachables Challenges January 25-26,2010, Radisson Warwick Hotel, Philadelphia, PA Key Learning Objectives: ·Understanding the Unique Container Closure System Considerations and Requirements for Various Drug Products ·Determining the Presence of Extractables and Leachables ·Understanding Testing Requirements for Container Closure Systems ·Evaluating and Selecting Materials for Container Closure Systems ·Developing Internal Quality Control Programs For Container Closure Systems ·Innovations in Container Closure Systems and New Industry Technologies Special In-Depth Session: Evaluating and Selecting Polymeric Materials for Container Closure Systems Featuring Representation From: BD Medical Pharmaceutical Systems Eakins & Associates Eli Lilly & Company Helvoet Pharmaceuticals Hyaluron Linda A. Walker Consulting, LLC Material Needs Consulting, LLC NAMSA Packaging Science Resources, Inc. Phase Technologies, Inc. West Pharmaceuticals Whitehouse Analytical Laboratories, LLC View Brochure I Purchase Materials

OUTSOURCING MANUFACTURING January 25-26,2010, Radisson Warwick Hotel, Philadelphia, PA Key Learning Objectives: ·Understand Supplier and Customer Issues in Outsourcing Relationships ·Learn Strategies for Making the Decision to Outsource ·Know How to Identify the Right Supplier for your Particular Outsourcing Need ·Understand How to Conduct Supplier Audits ·Learn Strategies for Awarding Projects and Engaging your Suppliers ·Understanding Technology Transfer Considerations for Successful View Brochure I Purchase Materials

DISSOLUTION TESTING Current Approaches to Dissolution Method Development, Validation and Regulatory Compliance for Poorly Soluble Drugs October 26-27, 2009, Radisson Warwick Hotel, Philadelphia, PA ·Incorporating Key Validation Requirements for Dissolution Testing Techniques ·Issues in Developing Bio-relevant Dissolution Methods ·Developing Robust and Accurate Dissolution Methods in Early and Late-Phase  Drug Development In-Depth Pre-Conference Workshop: Managing the Effect of Processing Conditions on Dissolution Variability: A QbD Approach Fernando Muzzio, Ph.D., Professor of Chemical Engineering, Rutgers University Hear Case Studies from: Wyeth Merck Dow Chemical and more. View Brochure I Purchase Materials

CLEANING VALIDATION A hands-on two day workshop covering the key components of cleaning validation planning, implementation and maintenance October 26-27, 2009, Radisson Warwick Hotel, Philadelphia, PA KEY LEARNING OBJECTIVES: ·Understand the Regulatory Requirements for Cleaning Validation ·Review the Phases of the Cleaning Validation Lifecycle ·Develop an Effective Cleaning Validation Master Plan ·Effectively Develop and Define Acceptance Criteria ·Learn How to Appropriately Address Deviations ·Implement Strategies for Change Control, CAPA and Ongoing Monitoring ·Understand Steps Towards Continuous Improvement View Brochure I Purchase Materials

Register by April 7th   and receive a $300 discount! PRACTICAL PHARMACEUTICAL MANUFACTURING A Two-Day, Hands-On Multimedia Workshop Covering Solid Dose Manufacturing June 22-23, 2009, Radisson Plaza Warwick, Philadelphia, PA KEY LEARNING OBJECTIVES: ·Understand the core regulatory components of cGMP ·Know the three mail types and the functions and components of mixing ·Understand why granulation is necessary and wet/dry granulation differences ·Learn about new technologies and how they can be utilized ·Understand the key guidances and current interpretation ·Learn about the principles and tools used for tabletting ·Know the key considerations for tablet tooling ·Understand principles and equipment considerations for coating ·Understand encapsulation and manufacturing considerations for soft- and hard-shell capsules Includes numerous hands-on examples and exercises! View Brochure I Purchase Materials

VALIDATION FUNDAMENTALS A Hands-on Two-Day Workshop Covering the Basics for Conducting a Successful Validation Effort June 10-11, 2009, Sheraton La Jolla Hotel, La Jolla, CA KEY LEARNING OBJECTIVES: ·Understand GMP and Validation Requirements ·ASTM E2500 Consensus Standard: Exploring New Thinking on Validation ·Master Planning for Validation Approaches ·Know the Critical Documents Needed for Successful Validation ·Validation Protocol Development and Defining Acceptance Criteria ·Protocol Execution Criteria and Addressing Deviations ·Learn Strategies for Ensuring the Operation Stays in a Validated State Including Multiple Interactive Exercises and Case Study Examples View Brochure I Purchase Materials

PRE-FILLED SYRINGES FORUM 2009 Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization of Pre -Filled Syringes June 10-11, 2009 Sheraton La Jolla, California Featuring Case Studies and Lessons Learned from Industry Experts! ·MATERIALS, DESIGN & CONSTRUCTION OF PRE-FILLED SYRINGES ·SAFETY CONSIDERATIONS & REQUIREMENTS ·NUMEROUS DEVELOPMENT CASE STUDIES ·MANUFACTURING & FILLING SOLUTIONS ·REGULATION & INSPECTION OF PRE-FILLED SYRINGES ·FUTURE MATERIALS FOR PRE-FILLED SYRINGE COMPONENTS Including Special Coverage On: ·Syringe Plunger Movement · Stopper Movements ·Development Case Studies · Bubble-Free Filling ·Manufacturing Solutions · Syringe Manufacturing ·Visual Inspection · Extractables & Leachables ·Container Closures · Combination Products View Brochure I Purchase Materials

QUALITY BY DESIGN (QbD) A hands-on two day workshop covering the key components of QbD concepts, implementation and product risk mitigation March 5-6, 2009 - Radisson-Warwick Hotel, Philadelphia, PA Key Learning Objectives: ·Understand Risk-Based GMP Compliance and FDA, ICH and ASTM Approaches ·Review Strategies for Defining Risk, Risk Factors and Risk Prioritization ·Understand the Basic Fundamentals and Approach of QbD ·Use QbD to Mitigate Product Risk in Engineering Drug Manufacturing Operations ·Understand the Connection Between QbD and Process Analytical Technology (PAT) ·Implement the Concept of Continuous Improvement Including Multiple Interactive Exercises and Case Study Examples! View Brochure I Purchase Materials

- IMPURITIES FORUM 2009 Strategic Identification and Detection, Control and Methods to Ensure Regulatory Compliance for APIs and Drug Products March 5-6, 2009, Radisson Plaza Warwick, Philadelphia, PA Examine FDA, ICH, and USP Approaches to the Control of Impurities Choose and Evaluate Tools for Impurities Identification Plus: In-Depth Extractables and Leachables Coverage: ·New Approaches Toward the Identification of Extractables and Leachables ·Toxicology and Risk Assessment Considerations ·Extractable and Leachable Considerations for Photoinitiators Special in-depth session: USP Approaches and Initiatives for Impurities Behnam Davani, Ph.D., United States Pharmacopeia (USP) Featuring representation from: Baxter Healthcare Merck & Company JAZZ Pharmaceuticals Schering-Plough Corporation Pfizer, Inc. Cerno Biosciences Hospira Inc. Lantheus Medical Imaging Pharmalytica Services Sangart, Inc. Sheinen and Associates TOXICON West Analytical Services View Brochure I Purchase Materials

- BARRIER ISOLATION TECHNOLOGIES New Technologies, Case Studies and Current Applications in the Usage of Isolator Systems January 12-13, 2009, Radisson Plaza Warwick, Philadelphia, PA ·Strategies for Assessing Isolator Performance and Containment Effectiveness ·Performing Sterility Testing and Environmental Monitoring within an Isolator System ·Case Studies and Design Considerations for Clinical Scale Aseptic Filling ·Containment Solutions for Closed Vial Technologies and Evaluating Isolator vs. RABS Technologies ·Decontamination of Isolators and Validating Glove Integrity ·Examining Blow/Fill/Seal Insert Technology ·Facility Design Considerations and Strategies for Process Equipment Integration ·Exploring Electron Beam Technologies Plus In-depth Session: Evaluating Contamination Concerns for Aseptic Manufacturing and Sterility Test Isolators Ken Muhvich, Ph.D., Principal Consultant, Micro-Reliance LLC Featuring Representation From: Advanced Electron Beams Applied Prime Technologies Aseptic Barrier Systems LLC ASEPTIC Technologies DSM Pharmaceuticals, Inc. IPS Isogen LLC. La Calhène, Inc. Micro-Reliance LLC Rommelag USA, Inc SafeBridge Consultants, Inc. SKAN AG STERIS Corporation Walker Barrier View Brochure I Purchase Materials

EXTRACTABLES & LEACHABLES 2008 Strategies to Ensure Safety and Compliance in the Packaging and Processing of Drugs and Biologic October 20 - 21, 2008- Sheraton La Jolla, San Diego, CA Featuring Case Studies and Lessons Learned from Industry Experts! ·Examine Best Practices for Extractables and Leachables and Assess and Manage Risk ·Determine Suitability for Use in Extractables/Leachables Assessments ·Manage Extractables and Leachables Resulting from Packaging Materials, Closures and  Excipients ·Determining Extractables and Leachables from Disposable Single Use Manufacturing  Systems In-Depth Pre-Conference Workshop: Eric B. Sheinin, Ph.D., Sheinin & Associates; Former USP Chief Science Officer and Ex-FDA Deputy Director, Office of Pharmaceutical Sciences View Brochure I Purchase Materials

LYOPHILIZATION OPTIMIZING THE LYOPHILIZATION CYCLE THROUGH STRATEGIC APPLICATION, PROCESSES and TECHNOLOGIES September 15-16, 2008 - Radisson-Warwick Hotel, Philadelphia, PA ·Examine Current Freeze Drying Technologies and Qualification Requirements ·Critical Factors in the Design and Optimization of Lyophilization Processes ·Developing a Lyophilization Cycle for a Range of Clinical Doses ·Considerations in Process Design and Validation for Lyophilized Drug Products ·Examining Container & Closure Needs for Lyophilized Drug Products Plus an In-Depth Pre-Conference Workshop: Global Regulatory and Compliance Requirements for Lyophilized Products Presented by: Douglas Stockdale, Ph.D., President, Stockdale Associates, Inc. Featuring Representation From: Baxter BioPharma Solutions BIOCORP Inc. GEA Lyophil North America Hollister-Stier Kiang Consultant Services Lyophilization Technology, Inc. Millennium Pharmaceuticals Inc. SCHOTT Pharmaceutical Systems West Pharmaceutical Services View Brochure I Purchase Materials

CONTAINER CLOSURE SYSTEMS Strategies for Selection, Compliance and Mitigation of Extractables and Leachables Challenges September 15-16, 2008 - Radisson-Warwick Hotel, Philadelphia, PA · Understand Current USP Standards for Container Closure Systems and Recent Changes · Strategies for Evaluating, Selecting and Qualifying Materials for Container Closure   Systems · Examine Suitability for Use Considerations Associated with Extractables and Leachables · New Methods for Determining Moisture in Container Closures · Strategies for Integrity Testing of Container Closure Systems · Examine Challenges and Case Studies in Container Closure Systems Plus In Depth Pre-Conference Workshop: Guidances, Regulations, and Requirements for Extractables and Leachables in Pharmaceutical Packaging and Devices Company Representation from: United States Pharmacopoeia Eli Lilly & Company Baxter Healthcare Corporation Bayer Health Care LLC Packaging Consulting and Training NAMSA CardinalHealth Ciba Expert Services Linda A Walker Consulting, LLC Phase Technologies, Inc., West Pharmaceutical Services View Brochure I Purchase Materials

2008 PRE-FILLED SYRINGES FORUM Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization of Pre-Filled Syringes June 5 - 6, 2008- Sheraton La Jolla Hotel, La Jolla, CA Featuring Case Studies and Lessons Learned! · Development and Commercialization of a Pre-Filled Product · Evaluating Proper General Trends for Autoinjectors and Pre-Filled Syringes · Manufacturing and Outsourcing Strategies of Pre-Filled Syringes · Examining Potential Interaction Between Pre-Filled Syringes and Biopharmaceutical   Products · Inspecting Pre-Filled Syringes for Both Particulate Matter and for Cosmetic Defects · Syringe Plunger Movement During Air Shipments · Suitability for Intended Use Considerations for Pre-filled Syringe Systems                                                                                                   ......And much more View Brochure I Purchase Materials

CONTAINMENT OF POTENT COMPOUNDS Implementing Risked-Based Approaches and Ensure Safety through Strategic Containment Operations and Processes May 29 - 30, 2008, Radisson-Warwick Hotel, Philadelphia, PA Lessons Learned from Leading Industry Experts: · Understand the Requirements for the Containment of Potent Compounds · Lessons Learned from the Field: Program Development and Implementation Steps · Retrofitting Existing Equipment and Facilities to Achieve Requirements · Defining Design Requirements and Achieving Innovative Design Approaches · Numerous Industry Case Studies on Design, Implementation and Risk Management Featuring In-Depth Coverage on: FLEXIBLE CONTAINMENT SYSTEMS Installation, Validation and Achieving Compliance Company Representation Includes: Genzyme Floura, LLC Ash Stevens, Inc. Powder Systems Ltd. Astrazeneca Torres Placa Industrial Corporation Containment Solutions Roche Colorado Corporation Hecht Germany ILC Dover’s Containment Products SafeBridge Consultants Inc. Stantec Consulting Services, Inc. IES Engineers View Brochure I Purchase Materials

QbD: QUALITY BY DESIGN Understanding and Implementing the FDA's Quality by Design Initiative for the Pharmaceutical Industry May 29 - 30, 2008 - Radisson-Warwick Hotel, Philadelphia, PA Case Studies and Lessons Learned from Leading Experts: · Facilitate Innovation and Continuous Improvement Throughout the Product Lifecycle · Provide Regulatory Flexibility for Specification Setting and Post-approval Changes · Streamline the Submission and Review Processes · Use a Risk-Based Approach to Designing Performance Characteristics for the Operation Used for the Manufacture of Drug Products · Understand the Regulatory Requirements for QbD Featuring an In-Depth Pre-Conference Workshop: IMPLEMENTING A QUALITY BY DESIGN (QBD) APPROACH View Brochure I Purchase Materials

$295 Per Conference  Proceeding MANAGING DRUG SAFETY: Strategic Adverse Event Management and Pharmacovigilance Strategies to Minimize Risk March 10-11, 2008 - Radisson Warwick Hotel, Philadelphia, PA Featuring Case Studies and Lessons Learned! · Detail the Differences Between the US and EU Requirements and Prepare for Worldwide   Safety Inspections · Understand the 3 FDA Guidances Concerning Risk Management Programs · Determine the Opportunities and Challenges of Patient Registries for Efficient Risk   Management · Management and Reporting of Adverse Events: Best Practices and Tools · How Adaptive Trial Design Can be Used to Maximize Drug Safety Information · Advanced Quantitative Post-Marketing Safety Signal Analysis In-Depth Pre-Conference Workshop: Strategic Risk Management Plan Development: Utilizing Current Tools to Ensure Safety and Expedite Approvals Led by: David I. Goldsmith, MD, FISPE, President, Goldsmith Pharmacovogilance and Systems Yola Moride, PhD, FISPE, President, International Society for Pharmacoepidemiology (ISPE) Featuring Representation from: Merck & Company Intrasphere ParagonRx Phase Forward - Lincoln Technologies SJ Pharma Consulting Sciformix Corporation United BioSource Corporation Sanofi Pasteur MSD Wyeth Apotex Almac Clinical Technologies View Brochure I Purchase Materials

$295 Per Conference  Proceeding 2007 LYOPHILIZATION CONFERENCE Optimizing the Lyophilization Cycle through Strategic Application, Processes and Technologies June 25-26, 2007 Radisson Warwick Hotel, Philadelphia, PA Featuring Case Studies and Lessons Learned from Industry Experts from Multiple Scale-Up and Cycle Development Projects! · Explore Current Methods in Cycle Development and Control · Developing a Lyophilization Process that is Beyond Trial and Error · Excipient Selection and Thermal Analysis of Formulation and Finished   Product · Chamber Considerations for Primary and Secondary Drying · Comprehensive Coverage! · Understanding Container and Closure Needs for Lyophilized Drug   Products View Brochure I Purchase Materials

$295 Per Conference  Proceeding IMPURITIES FORUM 2007: Strategic Identification and Detection, Control and Methods to Ensure Regulatory Compliance for APIs and Drug Products September 10-11, 2007 Radisson Warwick Hotel, Philadelphia, PA · Examine FDA, ICH, and USP Approaches to the Control of Impurities   Choose and Evaluate Tools for Impurities Identification · Genotoxic Impurities: Understanding the Additional Challenges Posed · Using Chromatography and Mass Spectrometry to Identify Impurities   Strategies for Residual Solvents Testing and Methods Validation EXTRACTABLES AND LEACHABLES COVERAGE! Toxicology Considerations and Risk Assessment Strategies Strategies for Identifying Leachables and Impact of Photoinitiators Determining Leachables Using HPLC Multi-Detection Systems View Brochure I Purchase Materials

$295 Per Conference  Proceeding ADAPTIVE TRIAL DESIGNS Maximizing the Use of Interim Data Analysis to Increase Drug Development Efficiency and Safety September 10-11, 2007 Radisson-Plaza Warwick, Philadelphia, PA · Featuring Case Studies and Lessons Learned From the Field:   Design, Planning and Implementation of over 300 Adaptive Trials · Know when to use an adaptive vs. traditional design and address possible pitfalls for   each type of design · Understand what is necessary to obtain FDA buy-in to proposed study designs · Know the associated costs and tackle difficulties that will be encountered with adaptive   design implementation · Plus! Practical Considerations for Adaptive Trial Management and Logistics   · Assuring quality of field monitoring and availability of clinical trial supplies   · Refining operations strategy: enrollment, CRA time, site efficiency and performance View Brochure I Purchase Materials

$295 Per Conference  Proceeding DISSOLUTION TESTING CONFERENCE Strategies for Selection, Data Interpretation and Analysis and BA/BE June 25-26, 2007 Radisson-Plaza Warwick, Philadelphia, PA · Learn Best Practices for Dissolution Testing from Leading Industry   Experts · Strategies for Selection of Dissolution Media for Poorly-Soluble Drugs · Detecting and Addressing Changes and Understanding Regulatory   Implications · Hear Industry Case Studies and Important Lessons Learned View Brochure I Purchase Materials