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Interpret Changing Guidelines • Strengthen Quality Programs • Prepare for Inspections

June 19-20, 2019
  • Silver Spring, MD

As the industry faces increasingly intense scrutiny from regulators, compounding pharmacies must quickly adapt to comply with changing quality standards and prepare for more frequent inspections. IVT’s 2nd Annual Compounding Pharmacy Compliance brings together industry leaders to break down these complex guidelines and discover best practices for compliance through engaging general sessions and two concurrent tracks addressing the unique challenges faced by 503A and 503B compounding facilities. This program provides the opportunity to engage with expert faculty and like-minded peers to ensure you are prepared to navigate this rapidly-shifting landscape, including USP and cGMP standards, Pharmacy State Board and FDA compliance, and strategies for preparing for and responding to FDA inspections.

Top Benefits of Attending:

  • Understand the nuances of revised and upcoming
    regulatory policies and standards
  • Hear FDA, Pharmacy State Board, and industry perspectives on developing integrated quality and compliance programs
  • Implement best practices for preparing for inspections and responding to 483s and warning letters
  • Prepare your facility and personnel to comply with USP and cGMP standards
  • Discover new monitoring, testing, and validation solutions
  • Learn to proactively engage with regulators
  • Collaborate with peers and share solutions to common issues
Powerful Benefits for All Compounding Pharmacies:
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:

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

Opportunities for networking with colleagues in 503B space are limited. Thank you for providing this
forum for learning and interacting.

Director, Corporate Quality, SCA Pharmaceuticals

2nd Annual Compounding Pharmacy Compliance

Interpret Changing Guidelines • Strengthen Quality Programs • Prepare for Inspections

As the industry faces increasingly intense scrutiny from regulators, compounding pharmacies must quickly adapt to comply with changing quality standards and prepare for more frequent inspections. IVT’s 2nd Annual Compounding Pharmacy Compliance brings together industry leaders to break down these complex guidelines and discover best practices for compliance through engaging general sessions and two concurrent tracks addressing the unique challenges faced by 503A and 503B compounding facilities. This program provides the opportunity to engage with expert faculty and like-minded peers to ensure you are prepared to navigate this rapidly-shifting landscape, including USP and cGMP standards, Pharmacy State Board and FDA compliance, and strategies for preparing for and responding to FDA inspections.

Top Benefits of Attending:

  • Understand the nuances of revised and upcoming
    regulatory policies and standards
  • Hear FDA, Pharmacy State Board, and industry perspectives on developing integrated quality and compliance programs
  • Implement best practices for preparing for inspections and responding to 483s and warning letters
  • Prepare your facility and personnel to comply with USP and cGMP standards
  • Discover new monitoring, testing, and validation solutions
  • Learn to proactively engage with regulators
  • Collaborate with peers and share solutions to common issues
Powerful Benefits for All Compounding Pharmacies:
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:

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

Opportunities for networking with colleagues in 503B space are limited. Thank you for providing this
forum for learning and interacting.

Director, Corporate Quality, SCA Pharmaceuticals