Compounding Essentails: PSSNY

Jamaica, NY US
April 21, 2024

Target Audience

All pharmacists

Learning Objectives

 

At the completion of the activity viewers will be able to:

 
At the completion of this activity, the participant will be able to:
Describe the genesis of USP Compounding Chapters. Be able to describe their scope and the overlapping regulatory authorities who could enforce the compounding standards.
Describe the relationship between USP General Chapters <795>, <797>, and <800> be able to describe the overlapping regulatory authorities who could enforce these USP standards.
Discuss the impact of the FDA’s Insanitary Conditions guidance document on daily practice.
Contrast the differences between Pharmacy Compounding and cGMP Pharmaceutical Manufacturing
Discuss the "A w" (Activity of Water) of CNSPs and its impact on the determination of proper determination of BUDs
Outline the attributes of a compliant non-sterile compounding training program.
Describe the proper establishment of QA & QC programs in the compounding of non-sterile dosage forms
Outline the attributes of a compliant non-sterile master formula record (MFR).
Describe the current regulatory environment with focus on the most common citations confronting compounders who manipulate drug product.
Describe the major changes to USP General Chapter <797> as they relate to the determination of Beyond-Use dating (BUDs) of CSPs
Describe the fundamental differences between the three compounding categories in USP General Chapter <797>
List ten (10) tangible take-aways for pharmacies (compounding supervisors) to add to their USP compliance plan.
Course summary
Available credit: 
  • 3.00 ACPE
    The Arnold & Marie Schwartz College of Pharmacy and Health Sciences is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Course opens: 
03/27/2024
Course expires: 
11/14/2025
Event starts: 
04/21/2024 - 9:00am EDT
Event ends: 
04/21/2024 - 2:00pm EDT
Cost:
$0.00
Add to calendar: 
Rating: 
5
St. John's University
81-98 170th St
Jamaica, NY 11432
United States

 

 

 

Lou Diorio, RPh- Is a principal of LDT Health Solutions, Inc. (LDT) a medication safety & quality management consulting company with over 70 years of combined pharmacy expertise serving clients internationally.

Lou is a graduate of Long Island University’s Schwartz College of Pharmacy.  Lou is an adjunct Professor of Pharmacy Practice for the college and a preceptor of pharmacy students.  Lou is a member of the College’s Alumni Executive Board.

Lou has extensive experience in IV and extemporaneous compounding, and lectures, writes, and consults on these topics; Lou lends his expertise to many State Boards of Pharmacy and is a nationally recognized subject matter expert on compounding, robotics & automation. Mr. Diorio has proctored the NYS Board of Pharmacy Licensure Exam (Part III) for Sterile Compounding. He has managed an FDA-registered cGMP manufacturing operation for Coram Healthcare (SoluNet™ LLC). 

Lou is an active APhA & ASHP member. Lou is a past Chair of APhA’s APPM Academy of Practice and Management, an APhA Fellow, and was the Chair of APhA’s Compounding Special Interest Group (SIG). He is also a past member of the Kappa Psi Pharmaceutical Fraternity Foundation Board of Directors, an advisor and past member of the New York State Council of Health System Pharmacists Research & Education Committee, and a member of the New Jersey Society of Health System Pharmacists Industry Relations Committee.

Since 1985 Lou has practiced in many clinical settings fulfilling many clinical & operational roles, including Chief Operating Officer of Hebrew Hospital Corporate Services, a multi-centered sub-acute and LTC hospital system in New York. He has also managed & practiced in homecare, hospital, and community settings.

During the Pandemic Mr. Diorio was asked by the New Jersey Board of Pharmacy to monitor the competency training, use of automation and quality management efforts at the four field hospitals serving the citizens of the State.

Lou is an Eagle Scout (with Silver Palm) and is still an active volunteer with the Boy Scouts of America.

Lou and his wife Kathi have two children Samantha (an attorney) and Michael (a civil engineer).

 

ACPE UAN #   0042-9999-24-019-L07-P

 

 

Available Credit

  • 3.00 ACPE
    The Arnold & Marie Schwartz College of Pharmacy and Health Sciences is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Price

Cost:
$0.00
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