Education Sessions by Track

Facilities and Project Delivery

Tight budget? Tight schedule?

Learn how you can integrate the demands of GMP requirements despite business constraints and project realities. Review case studies and engage in workshop forums to improve your ability to deliver your next project on time, on budget, and in compliance. Capital project managers, facility designers, owners, and contractors involved in project delivery will benefit from these programs.

Hear from companies and governmental agencies including:

Amgen • MedImmune • Roche • Cephalon • Eli Lilly & Co. • Becton Dickinson and Co. • Merck & Co., Inc. • Oso Biopharmaceuticals • US Environmental Protection Agency

Investigational Products

The world of clinical supplies will be entering one of its most dynamic regulatory phases ever.

Learn what’s on the horizon in the areas of Interactive Response Technology (IRT) and Supply Chain Optimization, and discover novel approaches to current industry challenges. Preview Good Practice Guides on the topics of IRT, Comparators and Booklet Labels currently in development.

Hear from companies and governmental agencies including:

GlaxsoSmithKline • Genzyme • Pfizer • Merck & Co., Inc. • AstraZeneca • Medicines and Healthcare Products Regulatory Agency (MHRA) UK

700: Mission Critical: Supply Chain Optimization in a Regulated Environment

Manufacturing Operations, Including Emerging Markets

Supply chain quality assurance… supply chain reliability…operational excellence…China…India…ASEAN… South America…Eastern Europe.

Executing successful business operations in an increasingly cost-constrained and globally diverse manufacturing environment is challenging. Regulators and industry professionals present state-of-the-art approaches and business-savvy techniques to help you meet those challenges. Professionals involved in site selection and permitting, manufacturing operations, supply chain management, and related fields will find these sessions beneficial.

Hear from companies and governmental agencies including:

Johnson & Johnson • AstraZeneca • Pfizer • Eli Lilly & Co. • GlaxoSmithKline • Celgene Corp. • Shanghai FDA • US Department of Homeland Security • California State Board of Pharmacy

Regulatory

ISPE is the premier organization for practical applications in a regulated GMP environment.

Help your organization adopt innovative approaches to regulatory compliance: reduce cost, reduce time and effort, manage quality risks, and improve quality of marketed products. Put your regulatory and GMP questions to a forum of distinguished panelists. Hear case studies and learn about new Guidance Documents.

Commissioning and validation professionals, those involved in quality assurance and regulatory compliance functions, and product and process development personnel will acquire critical information to help their daily professional work.

Hear from companies and governmental agencies including:

Abbott • Bayer • Eli Lilly & Co. • FDA Investigators • Johnson & Johnson • Roche

Technology

The key to both compliance and business success is technology that delivers reliable, efficient, quality products without contamination.

From the API process to final aseptic filling or solid dosage packaging, hear about the latest in manufacturing equipment and process technologies.

Engineers, scientists, service consultants, and operations personnel will benefit from these sessions.

Hear from companies and governmental agencies including:

Cook Pharmica • Genentech • Pfizer • US Department of Health and Human Services • Eli Lilly & Co. • Hospira