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Clinical Presentations & Public Speaking

As a leader in CSP compounding and medication safety, LDT can develop and present on a myriad of clinical and operational topics. These areas include but are not limited to:

  • Regulatory and other statutory compliance strategies, including the DQSA
  • FDA activity in and around compounding pharmacies, prescribers & institutional providers (including hospitals)
  • Automated Compounding Devices, Technologies & Techniques
  • Compounding Under USP <795> & <797>
  • Regional compounding of CSPs for your healthcare organization [503B model]
  • Medication Safety & Quality Improvement topics
  • Medication Quality Management & Policy Development
  • Improving workflow, operational efficiencies, & policy compliance in the cleanroom
  • Procurement strategies to assist in drug shortage situations
  • Formulary management to efficiently procure CSPs
  • Hazardous Drug compounding & Regulatory compliance - <USP 800> (OSHA & NIOSH topics)
  • Evaluation of drug stability data & determinations of BUD of CSP formulations
  • Personnel training programs for cleanroom operations
  • Cleanroom design & building basics

LDT can develop and present these topics live, by webinar, or as part of your organization’s staff development efforts.

Lou and Dave

Compounding Expertise

Whether your business depends upon sterile or non-sterile pharmacy compounding or both, LDT’s pharmacists and certified technicians have a wealth of clinical and technical expertise in both cGMP and Pharmacy compounding. The delivery of compounded sterile preparations (CSPs) in the current heath care delivery model requires both technical resources and the employee training to prepare and deliver these CSPs safely. At LDT our team has over 40 years of compounding, outsourcing, and formulation experience.

Cleam Room Image

We can analyze your process for regulatory and practice gaps. We can develop action plans for correction of these gaps, or analyze your operation for improvements or efficiencies to make your program better. Our experts can develop solutions that center upon the “controlled process” concept of using best-in-class” equipment and processes, in a defined and controlled way, consistently each and every time, and to document this process universally to satisfy any regulatory and oversight body.

Clean Room Image

LDT has developed compounding methodologies and accompanying documents for all types of pharmacy products including, Cardioplegia, Dialysate solutions (CVVH & CRRT), Total Parenteral Solutions (TPN), small volume preparations (SVPs) and Large volume parenterals (LVPs). Let us assist you in developing a consistent, solid library of compounding documents to reduce the possibility of errors and raise your level of quality in the mixing process.

Facility Design

Cleanroom Design Image

LDT can assist you in the expansion or re-model of your current pharmacy space, or in a total redesign of your clean room complex. No project is too large or small; each complex is designed with your organization’s specific needs and demands in mind. All our projects use the "Pharmacist’s Eye" to work flow and efficient movement of product both in and out of the rooms. We specialize in design with careful attention to local regulation, and USP 795 & 797 considerations.

Cleanroom Airflow Design Image

We can work with your organization’s contractors, architects, and builders to smoothly and efficiently get your complex build, validated, certified, and running. We also specialize in transition planning to assure that your critical functions are uninterrupted during any remodeling or construction. LDT has over ten years of experience in soft wall, hard wall, modular, and mobile clean room applications, please contact us for a consultation.

Outsourcing & Contract Compounding

The provision of contracted compounding pharmacy services from off-site providers is a growing model in healthcare. Beginning in the early 1990’s hospitals have moved high volume, fixed formulations to contract compounders (outsourcing providers) rather than compound these preparations themselves. LDT can assist at several junctures in this service paradigm.

Since November of 2013 with the enactment of the Drug Quality & Security Act (DQSA) the Congress has established Outsourcing Facilities under Section 503B of the Food Drug & Cosmetics Act. These 503B providers are expanding the areas where compounded sterile preparations (CSPs) can reach the patients who need them. Compounding these CSPs for office use, and institutional prescribing is an expanding marketplace.

With our experience in construction, developing and running successful multi-state compounding facilities under both Board of Pharmacy and cGMP regulation, LDT can guide you through the selection process if your organization, health system, or health network is contemplating such a shift in your medication delivery model.

Our services include:
  • Development of your selection criteria
  • Conformation of your project’s feasibility through the use of LDT’s own r-ROI™ (realistic-ROI cost modeling) for your projects budgeting.
  • Formulation of your RFP
  • On-Site Compliance Visits (both initial and on-going)
  • On-going QA Visits and Audits

LDT can develop as part of your overall 503B outsourcing strategy, a comprehensive plan to accommodate the remaining compounding demands of your organization once you have moved your fixed formulations off-site. This type of strategy can reduce your organization’s overall expense in complying with Federal, State, and Local regulatory burdens, while still maintaining your organization’s ability to compound on site.

This comprehensive strategy includes:
  • Clean Room Design & Contruction Expertise
  • Policy & Procedure Review and Development
  • On-Going QA Visits and Audits

Finally, if you are part of a larger organization or perhaps have excess capacity in your compounding suite, LDT has unique technologies and procedures to aid you in "in-sourcing" your organization’s compounding needs. By centralizing your compounding your organization may benefit from reduced overhead costs, better control, and total autonomy over your processes. This would include the review of available automation to assist you in maximizing you "in-sourcing" capacity.

LDT has several business models for "In sourcing" that may apply inside or outside your organization. Please contact us for more specific information regarding this unique opportunity.

Compounding & Gap Analysis
LDT can lend its experience and expertise to access your organization’s
compliance and regulatory readiness.

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Time & Motion Studies
LDT can assist in identifying areas for
improvement and suggest creative and
proven methods to maximize your staff’s

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Policy & Procedures
LDT can assist in this on-going activity by analyzing
your P&P collection to look for procedural gaps,
regulatory inconsistencies, and to assure that your
organization is operating using the latest best
demonstrated practices to strive for peak efficiency.

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Controlled Processes
Through the process of reviewing your organization’s activities
and focusing on the possible points of "critical failure" LDT can
develop systems which may minimize or eliminate these
"failure points" and enhance the overall quality of your products
or services.

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Action Planning
Once an organization has taken stock and identified key areas
for improvement or gaps in current practice, the task of
developing a "road-map" to get there is sometimes daunting.

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Plans Of Correction
LDT has a broad experience in the
formulation of custom POCs to address
State Board, FDA form 483 deficiencies,
and responses to FDA Waring Letters
and other agency correspondence.

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