Extractables & Leachables Boston 2019
Ensuring Quality, Safety, Suitability and Regulatory Compliance for Drugs, Biologics and Medical Devices
April 10-11, 2019, Metro Meeting Center, Boston, MA
This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteral drug products. In addition, we will focus closely on the keys to satisfying recent revisions to several applicable USP chapters and the recently revised standards contained in ISO 10993.
Featuring In-Depth Coverage On:
- The Ongoing Development of USP Chapters and Dealing with Materials and Components Used in Pharmaceutical Manufacturing Systems
- Issues Frequently Observed in Analytical Evaluation of Leachables in Drug Products (An FDA Review Experience)
- Toxicological Risk assessment of Medical Device Constituents-The New Working Draft of ISO 10993-17
- Understanding the Major Revisions to ISO 10993 and the New European Medical Device Regulations
- ISO 10993-18: Chemical Characterization of Medical Devices
- Application of ISO 109993-12 Exhaustive Extraction to Support Biocompatibility of Implantable Devices
- Exploring Biocompatibility Vs. Chemical Assessment in E&L Study Design
- Revisiting the PQRI/USP Identification Categories for Leachables and Extractables
- The Use of Simulation Extractions to Address Leachables for Single Use SystemsExtractable and Leachable Evaluation for Complex Pharmaceutical Formulations
- The Proper Use of Extractables Data - Aspects Beyond Extractables Measurement
- Advanced Identification Methods for E/L from Packaging & Manufacturing Components
- Understanding Leaching Associated with Lyophilized Drug Products Stored in Vial/Stopper Packaging Systems
With Representation From:
- FDA
- PPD
- Sartorius Stedim
- VR Analytical
- Fresenius Medical Care
- Intertek
- Med Institute
- Triad Scientific Solutions
- Nitto Avecia
- Knoell Germany GmbH
- Material Needs Consulting
- Smithers
- Exova
- Eakins & Associates
- Risk Science Consortium
- SGS
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Inhalation Drug Delivery Systems 2019
May 28-29, 2019, Boston, MA
Featuring In-Depth Coverage On:
- Regulatory Compliance Issues for Inhalation Therapies
- Combination Product Design
- Achieving An Inhaled Insulin Product
- Developing A Generic Inhaled Product
- Sterilization Issues Surrounding Inhalation Therapies
- Delivery of Inhaled Drug Products Using PRINT Technology
- Extractables and Leachables Testing
- Nebulizers, E-Cigarettes and Vaporizers: Past, present and future
- Alternative Therapeutic Fields: Inhaled Antibiotics
- Future directions in inhalation and respiratory drug delivery research
- Novel Technologies For Pulmonary And Nasal Delivery
- The Challenge Of Developing Inhalation Devices
- Applying QbD Principles to Inhalation Therapies
- Improving Patient Adherence With Product Design
- And more!
With Representation From:
- Genentech
- Merck
- GSK
- Aptar
- Smithers
- Harro Hofliger
- Nelson Labs
- Exova
- Intertek
- Toxikon
- EKG Labs
- Material Needs Consulting
- Vas Analytical
- University of Florida
- University of Texas
- Noveome
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2019 Process Validation Summit
June 12-13, 2019, Sheraton La Jolla, CA
Are you compliant with FDA requirements for process validation? Today's regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes throughout a drug product's lifecycle. This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.
With Representation From:
- AstraZeneca
- Bristol-Myers Squibb
- Bausch + Lomb
- Celgene
- Alphora
- Jubilant Pharma
- VTI Life Sciences
- Charles River Laboratories
- Pharmatech Associates
- SynoloStats
- VolPal
- Shook, Hardy & Bacon
- Compliance Team, Inc.
- Caliber Therapeutics
- Beckman Coulter
- Alcon
- STERIS
With Comprehensive Coverage On:
- Introduction to Recent Advances in Process Validation - Life Cycle Approach
- Regulations/ICH Guidance/FDA, EU perspective/PV, life cycle approaches
- Validation in the Biopharmaceutical Industry
- Continued Process Verification (stage 3) approaches, understanding & realization
- Quality-by-Design, PAT, Quality Risk Management - new product vs. legacy
- Statistical Process Control & Sampling Plans
- Global Tech Transfers and Process Validation Approaches
- Process Validation Biologics vs. Biosimilars, Biobetters
- Business Perspectives on PV
- Process Validation Biologics vs. Biosimilars, Biobetters, OTC Manufacturing
- Enhanced Sampling in Process Performance Qualification and Continued Process Verification
- Systematic Method for Process Development and Successful Implementation Based on Lessons Learned
- Process Validation as the Bridge from Clinical to Commercial
- Statistical Methods for Small-Scale Model Qualification in Bioprocessing
- Benefits of Establishing a True End-to-End, Close to Real-time Robustness Monitoring Program
- And Much More!
Early Bird Special: Register by April 1st and Receive a $200 Discount off of Standard Pricing!!
Microneedle, Transdermal & Intradermal Drug Delivery Systems, 2019
September 18-19, 2019, Metro Meeting Centers, Boston, MA
For the past six years, Pharma Ed's annual Transdermal & Intradermal Drug Delivery conference has attracted hundreds of attendees from the US and abroad. We bring together top experts from academia and industry to share their research in this emerging field of drug and biologics delivery.
Featuring In-Depth Coverage On:
- Latest Advances in Dissolvable Microneedle Technology for Drugs & Biologics
- Key Considerations for Microneedle and Microarray Patch Development
- Key Regulatory Considerations for Microneedle, TDD & IDD Systems
- From Bench to Clinic to Patient: Scale-Up to Manufacture of Commercial Microneedle Products
- New Trends in ID Vaccination and Immunotherapy
- Emerging Science: Transdermal Microneedle
- Sensors and Diagnostics
- Key Formulation Considerations for Skin-Mediated
- Novel TD Patch Designs and Technologies
- In Vitro Permeation Testing of Dermal Products
- Thermal Abrasion/Ablation Techniques for Enhanced Delivery
- Bioavailability Enhancement Techniques for Drug Delivery and Efficacy
- Overcoming Barriers to Macro-Molecule Delivery and Expanding the Range of Compounds for Use in TDD & IDD
- Risk-Based Strategies for TDD & IDD System Design
- In Vitro Release Studies for TDD & IDD Therapies and Vaccines
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Pre-Progam Rate: Register by March 1st for only $1,595!
Data Integrity & Pharmaceutical Quality Compliance Summit
October 3rd and 4th, 2019, Sheraton La Jolla, CA
Featuring In-Depth Coverage On:
- Regulatory Guidance for Data Integrity
- A Regulatory Global View on Data Integrity and its Importance
- Examining FDA Integrity Guideline
- Creating Data Integrity Programs
- Data Integrity During Process Validation and Commerical Product Transfers
- CMOs and Data Integrity
- How to Detect the Lack of Data Integrity
- Data Integrity for Complex Analytical Systems. How to Deal Effectively with Vendor-Provided COTS Solutions?
- Data Integrity in cGMP realized in global Pharma corporate projects
- Performing a Risk Assessment for Data Deficiencies
- Data Lifecycle Management
- Process Validation and Technology Transfer of Biologics and Vaccines
- Software Validation Case Study: Validation of MES System
With Representation From:
Early Bird Special: Register by July 1st and Receive a $300 Discount off of Standard Pricing!!
Cleaning Validation- October 15th and 16th
San Diego, CA
Cannabis and the Pharma Industry- November 13 and 14
San Diego, California