Cleaning Validation Summit 2016
May 23-24, 2016, Racquet Club of Philadelphia, PA
Are you compliant with FDA requirements for cleaning 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.
Featuring Representation From:
- Bristol-Myers Squibb
- Pharmatech Associates
- Hyde Engineering
- Astellas Pharma
Featuring Comprehensive Coverage On:
- Ensuring your Cleaning Program is FDA Audit Ready
- Cleaning Validation and Continued Process Verification
- Risk-Based Approaches to Cleaning Systems Design, Qualification and Ongoing Monitoring
- Cleaning Limits and Visual Inspection from the Analytical Perspectives
- Determine Cleanability and its Applications in Cleaning Validation
- Process Validation & Cleaning Strategies during Technology Transfer of Sterile Injectables
- EU GMP Changes and Its Impact on Cleaning Validation
- Quality by Design for Effective Cleaning Procedure
- Writing Cleaning Validation SOPs
- And Much More!
Early Bird Special: Register By April 15th and Save $200!
Transdermal and Intradermal Drug Delivery Systems, 2016
Advanced Design, Development, and Delivery of Skin-Mediated Therapies and Vaccines
September 12-13, Racquet Club of Philadelphia, PA
The growing interest in alternative routes of drug administration has experts predicting that the market for transdermal and intradermal drug delivery systems will exceed $30 billion in 2016. The industry is on the threshold of bringing into commercial production a new generation of transformative TDD and IDD therapies and delivery systems. That is why you cannot afford to miss this two-day intensive conference. Pharma Ed brings together leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.
Over 16 Featured Speakers, Including:
- Bobby Singh, Chief Technology Officer, Corium -- Keynote Presentation
- Lisa Dick, MTS Platform Manager, 3M Drug Delivery Systems
- Ajay Banga, Professor, Mercer Univ.
- Narasimha Murthy, Assoc. Prof., Ole Miss
- Audra Stinchcomb, CSO, F6 Pharma
- Harvinder Gill, Assoc. Prof., Texas Tech University
- Yash Kapoor, Assoc. Principal Scientist, Merck
- Mikolaj Milewski, Assoc. Principal Scientist, Merck
With Comprehensive Coverage on:
- Case Studies: Phase I & Phase II Clinical Trials using Passive TD and Microneedle Technology
- Modeling and Simulation of In Vivo Absorption of Large Molecules for ID Delivery
- Bioavailability Considerations for TDDS
- Key Formulation Considerations for Skin-Mediated Therapies and Vaccines
- Latest Advances in Microneedle Patches for Self-Administered Vaccinations
- Optimizing TDD & IDD for Efficacious Delivery and Patient Compliance
- Enhancement of Skin Permeation Using Supersaturation
- Expanding the Range of Compounds for Use in TDD & IDD
- Effects of Hypothermia in TDD
- Understanding Regulatory Issues & Requirements for TDD & IDD Systems
- Lowering Production Costs for TDD & IDD Therapies and Vaccines
- Mechanisms of Dermal and Transdermal Absorption of Drugs
- And More!
Early Bird Special: Register by June 17th and Save $200!
Lyophilization Forum, October 2016
Extractables, Leachables and Elemental Impurities, March 2017
Pre-Filled Syringes Forum, April 13-14, 2017
Process Validation Summit, May 2017