Pharmaceutical manufacturing is an increasingly global effort comprising a number of diverse variables. The potential of emerging markets drives prospects from established regulated markets to new frontiers of lower cost ingredients and higher product yields. However, manufacturers are still responsible for the safety and efficiency of their product and must develop and implement a global regulatory strategy to provide therapeutic medicines to the patients they service. Collaboration with local and global markets will assist in forming partnerships with regulation authorities ensuring all quality and safety systems span the complete spectrum of a product’s development.

Annual Meeting Connection

Understanding and Mitigating Risk – The Eye of the Beholder

Presenters will analyze revealing case studies to clarify regulatory perspectives and explore industry leaders’ insights to encourage preparedness and positive mitigating actions within a company operating culture. Speakers will present guidance in continuous manufacturing process design and implementation, global harmonization, Latin American regulatory climate, biotech QbD, ICH Q7, and raw materials.

Participants will gain a new level of understanding through participation in practical and relevant discussions focused on proactive approaches to compliance in a global environment.

Full Session Listing: 

  • Developments in Global Harmonization, Sunday, 12 October 13:00 – 15:00
  • Risk – Part I ,Sunday, 12 October 13:00 – 15:00
  • C&Q: Fulfilling Stage 2A of the FDA Process Validation Guideline – Part I, Monday, 13 October 09:30 – 11:00
  • Risk – Part II ,Monday, 13 October 09:30 – 11:00
  • Managing Assets and Equipment for Reliable Drug Supply, Monday, 13 October 09:30 – 11:00
  • C&Q: Fulfilling Stage 2A of the FDA Process Validation Guideline – Part II, Monday, 13 October 12:30 – 14:30
  • Modeling within the QbD Framework & Lifecycle Considerations – Part I, Monday, 13 October 12:30 – 14:30
  • Symposium on Process Capability: A Leading Quality Metric? Monday, 13 October 15:30 – 17:30
  • Modeling within the QbD Framework & Lifecycle Considerations – Part II , Monday, 13 October 15:30 – 17:30
  • Addressing Challenges in Implementation of the Lifecycle Approach to PV – Part I, Tuesday, 14 October 08:15 – 09:30
  • BIO-QbD – Part I Tuesday, 14 October 08:15 – 09:30
  • Addressing Challenges in Implementation of the Lifecycle Approach to PV – Part II, Tuesday, 14 October 10:15 – 11:30
  • BIO-QbD – Part II Tuesday, 14 October 10:15 – 11:30
  • Application of the Lifecycle Approach to PV to Continuous Manufacturing and FDA Perspective of Lifecycle Approach to PV Implementation Progress, Tuesday, 14 October 13:00 – 14:30
  • Drug Shortages, Tuesday, 14 October 13:00 – 14:30
  • Metrics, Tuesday, 14 October 15:30 – 18:00
  • Lifecycle Approach to PV Stage 3a and 3b – Case Studies, Tuesday, 14 October 15:30 – 17:00
  • Continuous Manufacturing – Part I, Wednesday, 15 October 08:00 – 09:15
  • Latin American Regulatory Compliance – Part I, Wednesday, 15 October 08:00 – 09:15
  • Global Expectations for Process Validation, Wednesday, 15 October 08:00 – 09:15
  • Continuous Manufacturing – Part II, Wednesday, 15 October 11:00 – 13:00
  • Latin American Regulatory Compliance – Part II, Wednesday, 15 October 11:00 – 13:00

Learn more about the education sessions planned at this year’s Annual Meeting by going to http://www.ispe.org/2014-annual-meeting

 

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