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PURCHASE MATERIALS
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Unable to attend in person? If you are not able to make it to a PharmaEd Resources event but would like to stay abreast of industry developments, conference proceedings are available for purchase. For more information, contact info@pharmaedresources.com or Click Here to order online.
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CONTAINER CLOSURE SYSTEMS 2010
Strategies for Selection, Compliance, and Mitigation of Extractables and Leachables Challenges |
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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
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OUTSOURCING MANUFACTURING
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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
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DISSOLUTION TESTING
Current Approaches to Dissolution Method Development,
Validation and Regulatory Compliance for Poorly Soluble Drugs |
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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.
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CLEANING VALIDATION
A hands-on two day workshop covering the key components of cleaning validation planning, implementation and maintenance
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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
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Register by April 7th and receive a $300 discount! |
PRACTICAL PHARMACEUTICAL MANUFACTURING
A Two-Day, Hands-On Multimedia Workshop Covering Solid Dose Manufacturing
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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!
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VALIDATION FUNDAMENTALS
A Hands-on Two-Day Workshop Covering the
Basics for Conducting a Successful Validation Effort |
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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
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PRE-FILLED SYRINGES FORUM 2009
Strategic Development, Inspection, Safety & Regulatory
Compliance and Commercialization of Pre -Filled Syringes |
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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
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QUALITY BY DESIGN (QbD)
A hands-on two day workshop covering the key components of QbD concepts, implementation and product risk mitigation
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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!
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IMPURITIES FORUM 2009
Strategic Identification and Detection, Control and Methods to Ensure
Regulatory Compliance for APIs and Drug Products
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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
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BARRIER ISOLATION TECHNOLOGIES
New Technologies, Case Studies and Current Applications in the Usage of Isolator Systems
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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
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EXTRACTABLES & LEACHABLES 2008
Strategies to Ensure Safety and Compliance in the Packaging and Processing of Drugs and Biologic
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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
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LYOPHILIZATION
OPTIMIZING THE LYOPHILIZATION CYCLE THROUGH STRATEGIC APPLICATION, PROCESSES and TECHNOLOGIES
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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
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CONTAINER CLOSURE SYSTEMS
Strategies for Selection, Compliance and
Mitigation of Extractables and Leachables Challenges |
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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
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2008 PRE-FILLED SYRINGES FORUM
Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization of Pre-Filled Syringes
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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
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CONTAINMENT OF POTENT COMPOUNDS
Implementing Risked-Based Approaches and Ensure Safety
through Strategic Containment Operations and Processes |
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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
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QbD: QUALITY BY DESIGN
Understanding and Implementing the FDA's
Quality by Design Initiative for the Pharmaceutical Industry |
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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
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$295 Per Conference Proceeding
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MANAGING DRUG SAFETY:
Strategic Adverse Event Management and
Pharmacovigilance Strategies to Minimize Risk
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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
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$295 Per Conference Proceeding |
2007 LYOPHILIZATION CONFERENCE
Optimizing the Lyophilization Cycle through
Strategic Application, Processes and Technologies |
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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
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$295 Per Conference Proceeding |
IMPURITIES FORUM 2007:
Strategic Identification and Detection, Control and Methods
to Ensure Regulatory Compliance for APIs and Drug Products
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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
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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
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$295 Per Conference Proceeding
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ADAPTIVE TRIAL DESIGNS
Maximizing the Use of Interim Data Analysis
to Increase Drug Development Efficiency and Safety
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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
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· 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
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$295 Per Conference Proceeding
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DISSOLUTION TESTING CONFERENCE
Strategies for Selection, Data Interpretation and Analysis and BA/BE |
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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
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