Join us for a seminar day where we discuss new trends and analytical challenges in pharmaceutical labs and how to address them. We will cover regulatory guidelines for methods transfer, method development, impurity analysis and data integrity, as well as hear from an industry expert on the quantitation of potentially mutagenic impurities.
Who should attend: Scientists and lab directors responsible for small molecule LC method development, method transfer and quality control, and anyone interested in learning about the regulatory landscape in the analysis of pharmaceuticals.
|9:00am||Breakfast and Registration|
|9:30am||Regulatory Risks with Methods Transfer
Bill Nyquist, Waters Corporation
This presentation will look at current guidance documents and programs that affect laboratory workflow today. In terms of separation science, method modernization and method lifecycle management are key themes that have emerged. Frequently, there is a reluctance to upgrade or improve methods for fear of validation efforts, refiling costs, or finding an additional peak that may need to be investigated, identified, and/or reported. This session will summarize the current thinking of the FDA, USP, ICH, etc. and serve as a springboard for discussions around the impact on today’s laboratory.
|10:15am||A Systematic Approach to Developing a Stability Indicating Method
Tilak Chandrasekaran, Waters Corporation
The stability of pharmaceutical products is of prime importance as it affects the safety and efficacy of the drug product. In recent year there has been an increased focus on the use of stability indicating methods. Understanding the various factors that affect the quality of drug substance or product is the key to developing a stability indicating method (SIM), which should accurately and precisely measures the active pharmaceutical ingredient (API) from potential interference like degradation products, process impurities, excipients and other potential impurities generated during storage.
In this presentation, we will explore the 3 key components to developing a SIM: obtaining a suitable sample to establish selectivity and specificity, systematic method screening and optimization and defining and streamlining validation requirements & reporting.
|11:20am||Data Integrity: Hot Topics, and Specific Chromatography Findings
Shirley Wong, Waters Corporation
The increased use of electronic data and computerized systems has introduced new challenges to maintaining data integrity. With pharmaceutical companies under increased scrutiny by regulatory authorities, companies need to ensure they have a thorough understanding of their regulated systems and how to assess them for gaps. In this talk, we will provide insight on the current focus for data integrity, and understand how chromatography systems address specific concerns and challenges when demonstration data integrity.
|1:15pm||Method Development Strategies for Potential Mutagenic Impurity Quantitation
Robert Menger, Scientist II, Analytical R&D, Celgene Corporation
ICH M7 defines Potentially Mutagenic Impurities (PMIs) as “...reactive substances that have a potential to directly cause DNA damage when present at low levels leading to mutations and therefore, potentially causing cancer”. The reactive nature coupled with the need for detection at trace levels often leads to unforeseen challenges during PMI method development.
Thus, choosing the appropriate analytical technique and understanding the reactivity of the PMI are critical to developing a sensitive and robust analytical method. This presentation will provide concise strategies and best practices for addressing these challenges. Additionally, two case studies applying these strategies in a pharmaceutical setting will be presented: a trace level HPLC-UV method to determine a boronic acid starting material in a synthetic intermediate, and a trace level GCFID method for mesityl oxide, a potential API process impurity/degradant that may result from the presence of acidic counter ion and residual acetone.
|1:45pm||Column Selection Tool Demo|
|2:15pm||Q&A, Concluding remarks|
For additional information or questions please contact: Lama_Berro@waters.com
Parsippany, NJ 07054