Pharma Analytics Summit
Statistical Approaches for Improving Performance and Compliance
March 26-27, 2018, Racquet Club of Philadelphia, PA
Use of statistics has been part of the FDA’s guidances and regulations for many years. Use of statistics is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Are you compliant with FDA requirements? 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:
- Eli Lilly
- Snee Associates LLC
- JnJ Vision Care
- Upsher-Smith Laboratories
- Insight, Advice and Solutions, LLC
- Excellent Pharma Consulting
- Catalent Biologics
With Comprehensive Coverage On:
- Solving Statistical Mysteries – What Does the FDA Want?
- Stability and Capability of Measurement System and Manufacturing Process is Fundamental to Pharmaceutical Quality Assurance in the 21st Century
- Strategies forAccelerating Process and Formulation Validation
- Measurement Systems Analysis and Some Useful Experimental Designs
- Continued Process Verification and Fit for Use Statistical Approaches
- The Need for both Fundamental and Advanced Understanding to Design Lean Statistical Approaches
- Test Method Robustness/Design Space
- And Much More!
Early Bird Special: Register by January 15th and Receive a $200 Discount!
Extractables, Leachables & Elemental Impurities 2018
Ensuring Quality, Safety, and Regulatory Compliance for Drugs & Biologics
March 28-29, Racquet Club of Philadelphia, PA
This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, and parenteral drug products. We will hear from key industry working groups such as PQRI and BPOG. In addition, we will focus closely on the keys to satisfying recent ICH and USP guidelines for metal impurities in current and future drug products and biologics.
With Representation From:
- Johnson & Johnson
- Eli Lilly & Co
- Jordi Labs
- West Pharmaceutical Services
- EKG Labs
- VR Analytical
- Material Needs Consulting
- Akorn Pharmaceuticals
Featuring Comprehensive Coverage On:
- Key Issues in Satisfying ICH Q3D, and USP Guidelines Regarding Elemental Impurities (EI)
- Update on revised USP for Materials and Components used in Pharmaceutical Manufacturing Systems
- Update on Revision of USP, for Plastic Material Components and Packaging Systems
- Update on revised USP for EI and Extractables for Elastomeric Enclosures in Injectable Devices
- Analytical Challenges in Extractable and Leachable Studies of Pre-Filled Syringes for Oil-Based Drug Formulations
- PQRI Thresholds and Best Practices for E&L for Biologics
- Designing and Improving Risk-Based Assessment of E&L Data for Drugs, Biologics, and Medical Devices
- E&L Considerations in the Qualification and Validation of Single-Use Systems
- Toxicology Assessment Approaches for E&L Studies
- E&L for Oral Dosage Forms
- Addressing Extractables & Leachables from Bioprocessing Equipment & Product Packaging
- And More!
Early Bird Special: Register by February 15th and Take $200 off the Standard Rate!
2018 Pre-Filled Syringes Forum
Strategic Development, Safety & Regulatory Compliance, and Commercialization of Pre-Filled Syringes
April 3-4, 2018, Racquet Club of Philadelphia, PA
With the Pre-Filled Syringes market expected to top $16 billion dollars by 2021, the industry is looking for next generation materials, technologies and production strategies to streamline commercialization and to adapt quickly to a changing regulatory environment. Pharma Ed Resources, an industry leader since 2004 in delivering market-driven research on PFS, is proud to announce its 2018 Pre-Filled Syringes Forum. Pharma Ed brings together top scientists, regulatory experts and innovators to share best practices and the latest research in this field, enabling you to maximize your organization’s leverage in this dynamic and growing market.
Featuring Representation From:
- Bristol-Myers Squibb
- Sanofi Genzyme
- Janssen R&D
- Eakins & Associates
Including Special Coverage On:
- Key Factors in Combination Product Development: Regulatory Hurdles in Receiving PFS and Pen Approvals for Human Factors Studies
- Patient Centric Designs For Pre-Filled Syringes
- Next Generation Materials & Design of Pre-Filled Syringes
- Improving Quality, Connectivity, and Cost Control in Combination Products & Auto injectors
- Smart Devices: Their Emerging Role in Auto-Injector Systems
- Sterile Manufacturing of Injectables at CMO's
- Extractables case study of resins HDPE, TPU & PEBAX
- Managing the Materials used to Construct Pre-Filled Syringes—Selection and Supply Chain Control
- Latest Market Trends and Needs for PFS
- Overcoming Complex Requirements for Biologic Drug Delivery
- And Much More!
Early Bird Special: Register by February 15 and Save $200!
Process Validation Summit- May 16-17, 2018
Cleaning Validation Summit- September 12-13, 2018
Transdermal and Intradermal Drug Delivery Systems, September 17-18, 2018
Inhalation Drug Delivery Systems- October 8-9, 2018