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Overview of USP and Ph.Eur. Allowable Adjustments for HPLC Monograph Methods
Dr. Philip (Phil) J. Koerner
Date: March 3, 2021
Time: 10:00 SGT (UTC +8)/ 13:00 AEDT (UTC +11)
There is an on-going effort between the USP and Ph.Eur. (and other national pharmacopeias) to harmonize the allowable adjustments for HPLC methods, however; at this time some differences do exist that can make it challenging for users of these validated Pharmacopeia monograph methods. This is especially true for companies that utilize both USP and Ph.Eur. monographs for their pharmaceutical drug substances and drug products. Understanding what adjustments are allowed and how they can help to avoid the need to revalidate methods, can result in improved laboratory efficiency and throughput. In this webinar, we will compare and contrast the allowable adjustments for USP and Ph.Eur. and include a couple of case studies.
About the Speaker:
Dr. Philip (Phil) J. Koerner is the Global Pharmaceutical Industry Manager with Phenomenex, located in Torrance, California, USA where he is accountable for developing, communicating, and leading strategic initiatives and integrated marketing programs globally to significantly increase Phenomenex’s presence in the pharmaceutical market.

Dr. Koerner has more than 30 years of experience in HPLC, GC, and sample preparation techniques; 11 years as a Senior Chemist with DuPont and 20 years with Phenomenex. In his previous role as Senior Technical Manager at Phenomenex, Dr. Koerner traveled extensively around the world sharing his expertise and experience with customers in the form of technical seminars, hands-on training, and technical assistance covering various topics in HPLC, GC, and sample preparation. He has also been an instructor for USP courses on General Chapters <467> (Residual Solvents) and <621> (Chromatography).

Dr. Koerner received his B.S. in Chemistry at the University of California, Irvine, earned his M.S. and Ph.D. in Chemistry at the University of Illinois, and an MBA at the University of Delaware.
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