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Navigate the Changing Regulatory Landscape and Enhance Quality Programs

September 17-18, 2019
  • San Diego, CA

Compounding pharmacies continue to grapple with a rapidly changing regulatory landscape coupled with increased enforcement at the state and federal level. As quality standards change, compounders must proactively adapt their procedures to remain compliant and ensure preparedness for more frequent inspections.

IVT’s 2nd Annual Compounding Pharmacy Compliance West provides a unique platform for industry leaders to come together, dive deep into complex guidelines and share solutions to enhance quality, achieve compliance and more confidently navigate the future of compounding.

NEW FOR 2019!

  • Concurrent tracks serving the unique needs of 503A, 503B, and Hospital & Health-System Compounding Pharmacies
  • USP <800> and <797> Readiness Roundtables

Collaborate on High-Impact Topics Transforming the Compounding Industry, Including:

  • Evaluate FDA Priorities and Policies for Oversight of
    Drug Compounding
  • Review FDA Guidance on Use of Bulk Substances and
    Essential Copies
  • Understand and Incorporate USP Standards into
    Compounding Practices
  • Mitigate the Impact of Drug Shortages on
    Inhouse vs. Outsourced Compounding
  • Develop Personnel Training for GMP Compliance
  • Prepare for and Respond to Inspections
Powerful Benefits for All Compounding Pharmacies:
Hospital & Health System
Benefits
  • Develop strategic protocols to respond to drug shortages and multi-faceted assessment processes to determine when to insource or outsource compounded drugs
  • Gain a better understanding of cGMP standards and how to choose outsourcing facilities with this knowledge
  • Build comprehensive, standardized educational programs to ensure compliance across health systems
  • Collaborate to share strategies for USP <800> and
    <797> compliance
  • Analyze the benefits of utilizing automated IV compounding systems and how to expand insourcing capabilities with robotics
 
503A
Benefits
  • Gain clarifications on USP 800 guidelines and strategies for minimizing costs of designing a compliant cleanroom
  • Evaluate FDA’s recently finalized rule on the 503A Bulks List and understand criteria for evaluating nominated
    bulk drug substances
  • Hear different perspectives on navigating state and
    federal guidelines for quality
  • Explore the benefits of adopting practices from 503B facilities to improve your quality program
  • Ensure inspection readiness and explore how to
    effectively self-audit
 
503B
Benefits
  • Break down how cGMP applies to your facility and how to prepare for a risk-based inspection
  • Maximize the impact of your training program to ensure staff compliance with rigorous quality standards
  • Engage with peers from 503B facilities to develop solutions to real-world compliance challenges
  • Ensure inspection readiness and explore how to
    effectively self-audit

Previous Attendee Acclaim:

Opportunities for networking with colleagues in the [compounding] space are limited. Thank you for providing
this forum for learning and interacting.

Director, Global Quality, SCA Pharmaceuticals

I was delighted to hear the speakers at the conference.
They were 100% open and willing to share their vast experiences with the group. It's great to hear from the
FDA and others in a collaborative environment. Congratulations on a successful conference!

Quality Assurance Manager, KRS Global Biotechnology

Overall, well run and informative. Speakers were knowledgeable… and learned information that
can be applied to current practice.

Owner, Harbor Compounding Pharmacy

Compounding Pharmacy Compliance West

Navigate the Changing Regulatory Landscape and Enhance Quality Programs

Compounding pharmacies continue to grapple with a rapidly changing regulatory landscape coupled with increased enforcement at the state and federal level. As quality standards change, compounders must proactively adapt their procedures to remain compliant and ensure preparedness for more frequent inspections.

IVT’s 2nd Annual Compounding Pharmacy Compliance West provides a unique platform for industry leaders to come together, dive deep into complex guidelines and share solutions to enhance quality, achieve compliance and more confidently navigate the future of compounding.

NEW FOR 2019!

  • Concurrent tracks serving the unique needs of 503A, 503B, and Hospital & Health-System Compounding Pharmacies
  • USP <800> and <797> Readiness Roundtables

Collaborate on High-Impact Topics Transforming the Compounding Industry, Including:

  • Evaluate FDA Priorities and Policies for Oversight of
    Drug Compounding
  • Review FDA Guidance on Use of Bulk Substances and
    Essential Copies
  • Understand and Incorporate USP Standards into
    Compounding Practices
  • Mitigate the Impact of Drug Shortages on
    Inhouse vs. Outsourced Compounding
  • Develop Personnel Training for GMP Compliance
  • Prepare for and Respond to Inspections
Powerful Benefits for All Compounding Pharmacies:
Hospital & Health System
Benefits
  • Develop strategic protocols to respond to drug shortages and multi-faceted assessment processes to determine when to insource or outsource compounded drugs
  • Gain a better understanding of cGMP standards and how to choose outsourcing facilities with this knowledge
  • Build comprehensive, standardized educational programs to ensure compliance across health systems
  • Collaborate to share strategies for USP <800> and
    <797> compliance
  • Analyze the benefits of utilizing automated IV compounding systems and how to expand insourcing capabilities with robotics
 
503A
Benefits
  • Gain clarifications on USP 800 guidelines and strategies for minimizing costs of designing a compliant cleanroom
  • Evaluate FDA’s recently finalized rule on the 503A Bulks List and understand criteria for evaluating nominated
    bulk drug substances
  • Hear different perspectives on navigating state and
    federal guidelines for quality
  • Explore the benefits of adopting practices from 503B facilities to improve your quality program
  • Ensure inspection readiness and explore how to
    effectively self-audit
 
503B
Benefits
  • Break down how cGMP applies to your facility and how to prepare for a risk-based inspection
  • Maximize the impact of your training program to ensure staff compliance with rigorous quality standards
  • Engage with peers from 503B facilities to develop solutions to real-world compliance challenges
  • Ensure inspection readiness and explore how to
    effectively self-audit

Previous Attendee Acclaim:

Opportunities for networking with colleagues in the [compounding] space are limited. Thank you for providing
this forum for learning and interacting.

Director, Global Quality, SCA Pharmaceuticals

I was delighted to hear the speakers at the conference.
They were 100% open and willing to share their vast experiences with the group. It's great to hear from the
FDA and others in a collaborative environment. Congratulations on a successful conference!

Quality Assurance Manager, KRS Global Biotechnology

Overall, well run and informative. Speakers were knowledgeable… and learned information that
can be applied to current practice.

Owner, Harbor Compounding Pharmacy