Featured Events!

Event Sponsors:

Extractables, Leachables, & Elemental Impurities 2017

Ensuring Quality, Safety, and Regulatory Compliance for Drugs & Biologics

March 6-7, 2017, Racquet Club of Philadelphia

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines, as well as the upcoming revisions to three major ISO 10993 standards. 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:

  • Boehringer Ingelheim
  • Allergan
  • Pfizer
  • Genentech
  • Amgen
  • NSF Health Sciences
  • Janssen
  • Eurofins
  • Merck
  • Aspen Research
  • Lilly
  • Boston Analytical
  • Regeneron
  • West Pharmaceutical Services
  • Sanofi
  • Material Needs Consulting
  • Baxter
  • Eakins & Associates

Featuring Comprehensive Coverage On:

  • Updates & Case Studies on the Latest Compliance Implications of USP and and ICH Q3D Risk Assessment Filing Guidelines for Elemental Impurities
  • The Risk Assessment of Extractables - A Toxicological Window of Opportunity
  • BPOG's Leachables Best Practice Guide: Study Design and Analytical Methods
  • Challenges & Consequences for the Medical Device Industry by the Revision of Three Major ISO 10993-Standards
  • Extractables Screening of Polyproylene Resins for the Identification of Suitability for Use Hazards
  • Clearance of E&L from Single-Use Technologies through Ultrafiltration/Diafiltration
  • Leachable Risk Assessment of Dosing Devices for Parenteral Applications
  • Extractables & Leachables Studies on Single-Use Components in Biomanufacturing
  • Addressing Challenges with Polysorbate 80
  • E&L Test Methodologies for Lyophilized Drug Products
  • Industry Working Group Updates: PQRI & BPOG
  • And More!

Early Bird Special: Register by January 27th and Receive a $200 Discount!

Process Validation Summit 2017

May 18-19, 2017, Philadelphia, PA

Are you compliant with FDA requirements for process validation? This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.

With Representation From:

  • FDA
  • Abbott
  • Bayer
  • Genzyme
  • GSK
  • QPharma
  • Patheon
  • Pfizer
  • Arlenda
  • Snee Associates
  • PharmaTech Associates
  • Compliance Team Inc
  • ResMedica
  • Stat4Ward
  • Takeda
  • BergumSTATS
  • TARIS Biomedical
  • Tunnell Consult

Featuring Comprehensive Coverage On:

  • FDA Process Validation and Risk Management Approaches
  • Lifecycle Approach to Process Validation
  • Global Technology Transfer and Process Validation
  • Achieving the Business and Compliance Benefits of Quality by Design (QbD) and Continued Process Verification (CPV)
  • Legacy Products - 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
  • Establishing a Continuum of Criticality for Process Parameters and Quality Attributes Throughout the Lifecycle
  • Process Control Strategy and Process Performance Qualification of a Drug/Device Combination Product
  • The Drug Supply Chain Security Act-How Does it Relate to Validation?
  • And Much More!

Early Bird Special: Register by March 15th and Save $200!

Pre-Filled Syringes Forum

Strategic Development, Safety & Regulatory Compliance, and Commercialization of Pre-Filled Syringes

April 13-14, 2017, Boston, MA

Full brochure coming soon!

Sponsorships & abstracts currently being accepted!

Contact: Christine Standley
cstandley@pharmaedresources.com, or call 217-621-6049

Upcoming Events

Lyophilization Forum, June 2017

Philadelphia, PA

Why PharmaEd?

Profitable Networking

Industry innovators and established professionals meet to share ideas, forge relationships, and imagine new opportunities.

Experience You Trust

Our team has over four decades of combined experience producing conferences and delivering real value to the pharma industry.

An Industry Leader

Pharma Ed has collaborated with over 250 companies and organizations to produce some of the most informative meetings in the industry.

Our Mission

To deliver the most current, market-driven information to meet your research, product development, regulatory, quality assurance, and technical needs.

Relevant Training

Cutting-edge knowledge drawn from top pharmaceutical, biotech, and academic experts.

Sponsorship Opportunities!

Sponsor a PharmaEd event and set your business apart!


What People Are Saying About
Pharma Ed Events

"A Fantastic meeting. I was interested in so many of the talks and I met several clients - current and potential."
- Principal Scientist, Aptuit SSCI

"I really enjoyed the meeting... Stronger speakers and more in depth coverage than some of the others on the market."
- Director, Emerson Resources, Inc.

"Thank you again for such an excellent program - it was very informative and enjoyable."
- Sr. Principal Scientist, Bausch + Lomb

"I go to a lot of conferences, and this was an excellent one."
- Sr. Scientist, Boehringer Ingelheim

"Great audience, with good choice of speakers. Would love to attend again."
- Principal Scientist, Pfizer

"I greatly enjoyed the conference. I found the topics relevant and containing great content. I look forward to bringing the knowledge and principles to my role in R&D."
- Manager, CSL Behring

"I was very pleased with the material presented, and the expertise of the presenters. I will be taking much valuable/applicable knowledge back to my company."
- QA Director, Biothera

"Each and every presentation contained information that I found to be useful and relevant and many presentations left me with ideas and concepts that I look forward to considering in greater detail."
- Distinguished Scientist, Baxter

"The presentations & experience of the presenters was very instructive & helpful toward building my programs."
- QA/Corporate Director, Medicago, Inc.

"This is a valuable conference, with many expert speakers."
- Product Manager, EMD Millipore

"I really enjoyed it. I feel engaged and like there is a lot to learn."
- Assoc. Scientist, Bristol-Myers Squibb