PROGRAM
SUMMARY:
Regulated laboratories often struggle with restrictions associated with ‘registered analytical procedures’ or methods. Despite encouraging a culture of continuous improvements, regulatory affairs groups are often reluctant to address the burden and cost of gathering pre-approval from regulatory health authorities for changes, even when these offer clear robustness improvements, or offer significant laboratory cost savings.
The ICH harmonization group issued a Quality guidelines Q12, in 2019, which offered a suite of tools to ease the regulatory burden of post approval changes. While the main focus of this was on manufacturing processes, one section plus an entire Annex was devoted to changes to analytical procedures. A separate ICH working group, specializing in analytical procedures, has been collaborating with a variety of global pharmacopoeia, on a lifecycle approach to analytical procedures, and devised an enhanced method development concept, to be published in ICH Q14, to support the ICH Q12 overarching concept. This promises to be a game changer for regulated laboratories looking to regularly improve and modernize the sensitivity and robustness of their analytical procedures.
In addition, the
EU and US pharmacopeia , again through the ICH harmonization process, plan to
expand their scope for minor adaptations to chromatographic analyses, from
purely restricted to isocratic separations to include well defined changes for
gradient separations as well.
Both of these
topics will be discussed in this webinar with time to ask questions for live
answer, or post event responses.
SPEAKERS:
Shreekant Karmarkar, PhD
Dr. Karmarkar has over thirty years of leadership
experience at analytical instrumentation and pharmaceutical companies. At
Lachat Instruments (now a Danaher-Hach company), he led development of ion
chromatography and flow injection analysis instrumental techniques. During his
16 years of career at Baxter Healthcare, he successfully implemented AQbD for
chromatographic and non-chromatographic methods. Dr. Karmarkar led
analytical development global teams on validation and transfer of hundreds of
methods for excipients, drug substance, drug products at in-process, release,
stability testing, and cleaning validation.
Now, as an independent consultant, Dr. Karmarkar
provides analytical leadership to startup and mid-size Pharma companies,
compliance issue resolution support, CMC sections submission services and
technology transfer programs. One significant achievement was conceptualization
of a new Analytical Center of Excellence for a major Indian CRO.
Jonathan
E. Turner, Principal Product Marketing Manager, Analytical Columns
Jonathan E. Turner is the Product Marketing Manager for analytical LC columns at Waters Corporation. He joined Waters Corporation in 2006 as a research chemist in the Chemistry Research and Development Group. In 2015 Jonathan transitioned from the laboratory to the Chemistry Product Management Group. In this new role he uses his expertise in chromatographic media to help design, develop, and commercialize new modern stationary phases.
MEETING MANAGER:
Quincy Logan, Boston Analytical
PROGRAM FEES:
Member: FREE
Student Member: FREE
Emerging Leader Member: FREE
Non-Member: $15
Registration Deadline is Thursday, March 24 at 10:00 am EST.
LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.
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