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What's New this Fall Semester? (RAQA)


Fall 2023 - What's New this Semester?

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What makes the RAQA program so outstanding and the best of its kind?  Answer: its amazing, incredibly talented and dedicated faculty, many of whom who have taught 20 or more years in our program, helping to shape and develop its curriculum.  Since we have so many outstanding teachers from FDA and industry, it would be difficult to name them all without publishing a small volume about all of their exciting offerings.  Here are just a few highlights of our Fall offerings.  

1. We are proud to offr the MS degree in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA) in partnership with Thomas Jefferson University.  The new degree opens exciting  career opportunities in this rapidly growing field. We encourage our students in both RA and QA to view the outstanding course offerings in this area, since there is an immediate need for professionals who are well versed in both the manufacturing and regulatory aspects of biotherapeutics.  Students pursuing the MS in RAQA should consider taking Dr. Diana's 5515 course (Biologics/Biosimilars) or Professor Quinn's 5577 (CMCs-Biopharmaceuticals) or Dr. Surowitz's 5572 (Vaccines) courses. Students pursuing the Drug Development Certificate could  also choose one of those courses as their elective to broaden their portfolio.  The best way to prepare yourself for your industry career is to take courses from as many areas as possible, and this is certainly the fastest expanding industry sector. 

2. Speaking of the ABMRA degree, we are delighted that Professor Casaburi, a beloved instructor in the RAQA program for over two decades and a central figure in the development of the Sterile Process Manfuacturing Certificate, returns to offer yet another course on parenterals this fall:Development of Sterile Products (5501), one of three courses he developed and teaches in this highly important area.  His classes are full of his amazing scientific knowledge of parenteral products, so whether you're pursuing the MS in RAQA, ABMRA or the Certificate in Sterile Process Manufacturing, don't miss this seminal course, which is only offer once every two years.  

3. An inventor and renowned authority on Cleaning Validation, Professor A. Walsh returns this fall to teach his very popular and fascinating course on Cleaning Validation. Whether you are a novice to cleaning validation or a senior director of QA, Professor Walsh special gift is to teach to all levels of student knowledge.  The course includes a field trip to CPCI, where you'll do hands-on cleaning validation on state-of-the-art equipment.

4. Do you suspect you might have "statistics phobia," but at the same time you realize how critical statistical analysis is within regulated industry?  Consider taking Dr. K. Weiss's excellent course on Statistics for Clinical Trials (course 5479), which doesn't require a background in statistics but delves into important statistical concepts and how they are applied in interpreting clinical trials.  You'll gain an overview of key statistical concepts as well as an indepth understanding of the various statistical methodologies utilized in the analysis of clinical trial data.

5. We welcome back Professor S. Wilson, who will be offering her high-energy course on Good Laboratory Practices (GLPs) (5476) this fall.  GLPs fulfills the GxP requirement in both the MS in RAQA as well as the Drug Development Certificate.  If you already have experience in GMPs and/or GCPs, register for this course on laboratory GxPs to deepen your familiarity with this critical aspect of the development of therapeutic products.   

6. Another way to broaden your career options is to take Professor M. Noonan's outstanding course in Food Law, which reviews landmark judicial decisions around the regulation of food as well as enforcement actions against adulterated food products.  You'll also learn about the importance of the Food Safety Modernization Act (FSMA), which provided the FDA with new enforcement tools to protect U.S. food safety.   

7. Another hot topic to study this fall:  Computerized Systems Validation with Professor T. Preziosi.  An added bonus:  this course meets over the lunch hour (East Coast time) or morning (West Coast time) twice a week with a one-hour recording to view each week, giving you greater flexibility on evenings and weekends.  Most important:  Professor Preziosi is a well known, global consultant in this hightly critical area, so you'll glean amazing facts and insights into the many layers of CSV.

8. Don't miss taking a course with Professor D. Schoneker, a world authority in global excipients as well as dietary supplements and functional foods.  This fall, he's offering his amazing course on Global Pharmaceutical Excipient Regulation (5546), which delves into so many complexities of global regulations when considering excipients used with pharmaceutically active products from sourcing, storage, manufacturing, shelf-life, and more.  

9. Don't wait to register for Professor Labruto's Pharmaceutical Quality Management Systems (5574) this fall!  It's one of those courses that usually closes a few days after we post the schedule, since Professor Labuto is such an expert and beloved instructor in the RAQA graduate program.  

10. Don't forget that you can earn 1.5 credits at upcoming KENX fall conferences this fall:  in fact, you can even earn 3 credits BEFORE the official start of the RAQA fall semester (Sept 9) by taking two back-to-back KENX courses during the week of August 21.  KENX conferences can be attended in person or online, giving you greater flexility with fitting in your pursuit of your graduate degree with your work obligations.  To lean more about KENX conferences, click here.

11. Dr. Saha returns to teach his excellent course on Microbiological Concepts in Pharmaceutical Manufacturining (5512).  He schedules it in 1.5 hour segments, twice a week, which makes it easier to comprehend and then ponder the fascinating details and important regulatory concepts he covers in every session. It's a must for students interested in QA, QC and manufacturing.

12. Travel plans in September?  You can still take a fall course starting in October!  (See Dr. Surowitz's Vaccines course (5572).

These are just a few of our many great courses and instructors. WOW!  There are so many more that it's hard to choose.

Have a great fall semester with Temple's RAQA program.