How to Prepare for an Audit as a GxP Inspector

How to Prepare for an Audit as a GxP Inspector

In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor.

Here are some of the topics we covered in our talk:


✅The Art Behind Being a Great Auditor

✅The Biggest Challenges of an Auditor

✅Why Companies Should Be Here Is Why Companies Should Be Happy to Be Audited

✅The Best Thing About Auditing

✅Why the Opening Is So Important for a Successful Audit

✅Knowing the Scope Is the Foundation of the Audit

✅The Most Common Mistakes of Audit Preparations-

✅Expert Tips for Junior Auditors on How to Learn Their Standards


Jennifer served as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant with expertise in GCP/GVP/GMP/GDP.

Denne episoden er hentet fra en åpen RSS-feed og er ikke publisert av Podme. Den kan derfor inneholde annonser.

Episoder(83)

Modernizing Pharmaceutical QC Laboratories From Locked Data to AI‑Powered Decisions [Jon Welsh]

Modernizing Pharmaceutical QC Laboratories From Locked Data to AI‑Powered Decisions [Jon Welsh]

Imagine unlocking 20 years of QC data to let AI forecast instrument downtime. John Welsh of Agilent reveals how the Allotrope simplified model and modern lab informatics turn compliance into a competi...

22 Sep 39min

Reducing Risk and Costs: Continuous Water Quality Monitoring in Pharmaceutical Production

Reducing Risk and Costs: Continuous Water Quality Monitoring in Pharmaceutical Production

In this episode, Yan Kugel and Konrad Sägesser discuss the latest trends and practical solutions in pharmaceutical water quality monitoring. Learn how continuous analytics, compliance, sustainability,...

31 Aug 33min

Overcoming Tech Transfer Bottlenecks: From Paper Trails to Standardized Digital Hubs [Nikki Bishop]

Overcoming Tech Transfer Bottlenecks: From Paper Trails to Standardized Digital Hubs [Nikki Bishop]

Can a single click replace years of tech transfer paperwork? Nikki Bishop, VP of Marketing & Experience at Emerson , reveals how AI‑driven digitization could slash delays for pharma, biotech, med‑tech...

25 Jun 51min

Transforming Pharmaceutical Development with Active Packaging [Badre Hammond]

Transforming Pharmaceutical Development with Active Packaging [Badre Hammond]

Can custom active‑packaging technology add three years to a drug’s shelf life?Badre E. Hammond, Global VP of Aptar Active Material Science, reveals how early‑stage material science can slash developme...

4 Jun 44min

How Process Analytical Technology Moves Quality into Real Time - Stanislav Kasakov

How Process Analytical Technology Moves Quality into Real Time - Stanislav Kasakov

Process Analytical Technology (PAT) has evolved from a niche troubleshooting tool into a strategic necessity—but most companies still implement it too late.  Dr. Stanislav Kazakov from Thermo Fisher S...

13 Mai 57min

Driving Global Quality in Viral Vector Manufacturing with Melanie Kearney

Driving Global Quality in Viral Vector Manufacturing with Melanie Kearney

What does it take to keep pharma & biotech CDMOs inspection‑ready across global sites? Senior VP of Global Quality, Melanie Kearney, reveals how she transforms quality culture, bridges R&D and manufac...

29 Apr 55min

Agility in Pharma: Transforming Challenges into Opportunities [Elizabeth Hickman]

Agility in Pharma: Transforming Challenges into Opportunities [Elizabeth Hickman]

Yan Kugel is joined by Elizabeth Hickman, the CEO at AustinPx. With over a decade of experience in the biotech and pharmaceutical sectors, Elizabeth shares her insights on drug development, innovative...

26 Nov 202433min

 Risks and Rewards in GMP Process Automation [Will Moss] #77

Risks and Rewards in GMP Process Automation [Will Moss] #77

In this episode, Yan Kugel is joined by Will Moss founder and CEO of Seal, about the critical need for automation in GXP processes. Will shares his expertise on balancing automation with human oversig...

3 Sep 202443min

Populært innen Vitenskap

fastlegen
romkapsel
tingenes-tilstand
jss
liberal-halvtime
forskningno
rekommandert
sinnsyn
tomprat-med-gunnar-tjomlid
villmarksliv
rss-paradigmepodden
fjellsportpodden
rss-nysgjerrige-norge
nordnorsk-historie
grunnstoffene
rss-rekommandert
tidlose-historier
rss-inn-til-kjernen-med-sunniva-rose
psykopoden
smart-forklart