Process Validation Summit 2018
May 17-18, Racquet Club of Philadelphia, PA
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:
- Q Pharma
- PharmaTech Associates
- Validation Edge
- Tunnell, LLP
- Wiley Rein, LLP
- Compliance Team, Inc.
- Snee Associates
Featuring Comprehensive Coverage On:
- FDA Process Validation and Risk Management Approaches
- Lifecycle Approach to Process Validation
- Global Technology Transfer and Process Validation
- Scientific and practical considerations of small scale model qualification and related statistical analyses for biopharmaceutical manufacturing processes
- Legacy Productsâ€”From Retrospective to Prospective Process Validation
- Validation Sampling Plans and Statistical Process Control
- Cost-effective Process Validation Lifecycle Management
- Implementing a Comprehensive Strategy for Process
- Validation: Stage 3, Continued Process Verification
- Assessing the Practical Signi cance of Statistical Study Results
- Revalidation of Biopharmaceutical Drug Product Manufacturing Process
- And More!
Transdermal and Intradermal Drug Delivery Systems, 2018
Advanced Design, Development, and Delivery of Skin-Mediated Therapies and Vaccines
September 6-7, 2018, 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 by 2020. 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:
- Caroline Strasinger, FDA (pending approval)
- Lisa Dick, 3M
- Bobby Singh, Corium
- Harvinder Gill, Texas Tech
- Yasmine Gomaa, Georgia Tech
- Audra Stinchcomb, F6 Pharma
- Ajay Banga, Mercer University
- Narasimha Murthy, Ole Miss
With Comprehensive Coverage on:
- Product Development and Quality Control Expectations with Respect to Transdermal and Topical Systems
- Key Formulation Considerations for Skin-Mediated Therapies and Vaccines
- Latest Advances in Microneedle Technology for Biologics
- Semisolids to Patches to Delivery Technologies: Unique IVPT Challenges As We Adapt the Franz Cell
- Novel TD Patch Designs and Technologies
- Heat Effects and IVIVC in Transdermal and Topical Drug Delivery
- In Vitro Permeation Testing of Dermal Products
- Understanding Regulatory Issues & Requirements for TDD & IDD Systems
- Overcoming Barriers to Large Molecule Delivery and Expanding the Range of Compounds for Use in TDD & IDD
- Scale-Up to Manufacture of TDDS and IDDS
- Risk-Based Strategies for TDD & IDD System Design
- Mechanisms of Dermal and Transdermal Absorption of Drugs
- In Vitro Release Studies for TDD & IDD
Full Conference Agenda Coming Soon!
Pre-Conference Special: Register Now & Receive a Pre-Conference Rate of Only $1,095!
2018 Cleaning Validation Summit
Cleaning Standards For Drugs and Devices From Industry Experts
September 12-13, 2018, Philadelphia, PA
Are you up to speed on the Science, Risk and Statistics based approaches for Cleaning Validation? Today's regulators are now asking for, and expecting, ADE Monographs and Risk Assessments of Cleaning Validation Programs. This two-day, intensive summit brings together the industry leaders on science and risk and statistics based cleaning.
Over 15 Featured Speakers, Including:
- Colleen Thomas, FDA (pending approval)
- Mohammad Ovais, Amgen
- Jessica C. Graham, BMS
- Andrew Walsh, Cleaning CPCI
- Fred Ohsiek, Bayer
- Igor Gorsky, Concordia Valsource
- Robert Jernigan, GSK
- Joe Cagnassola, Alcon
- Robert Kowal, Johnson & Johnson
- Mariann Neverovitch, BMS
- Thomas Altmann, Ecolab
- Beth Kroeger, Steris Corporation
- Stephen Spiegelberg, Cambridge Polymer Group, Inc.
Full Conference Agenda Coming Soon!
Pre-Conference Special: Register Now and Receive a Pre-Conference Rate of Only $1,095!
Inhalation Drug Delivery Systems- October 8-9, 2018