Presentations

Warning Letters – Brochure

So, you’ve received a warning letter… what do you do now?

It’s important to get a clear understanding of the message that the regulatory authority (FDA), is trying to send to your company.

It’s not just about the words, it’s more about what the intent of the observations listed is trying to convey. More often than not, the observations are illustrative of wider compliance concerns, so you need to look past just answering/addressing observational deficiencies. This is a trap that many fall into and it’s often a big mistake!

Download Brochure to read more…

Presentation: Warning Letters, Consent Decrees and cGMP Compliance

Lean Lab Design

Value Stream Mapping for Manufacturing Organizations

Biopharmaceutical Processes: Waste

Global Conference Presentation

This presentation covers the material presented at the Global Pharma Sourcing Conference.
Philadelphia, PA – December 2011
Summary:

This presentation deals with aspects of optimizing Quality assurance/Quality Control factors of a Global Sourcing Procurement Strategy and answer some questions related to this that were posed by the conference moderators.

In particular:

How to develop a Supplier Policy as a key element of a Quality System that assures success.
Tips related to performing appropriate due diligence to develop Best Practices and assure success.
The role of the Quality Audit as part of a Supplier Best Practice and what to look for.
What can be learned from analyzing Warning Letters and FDA activities?

GxP Audit & Risk Management Presentation

This presentation was given at the GxP Audit & Risk Management Congress.
Loews Philadelphia Hotel, Philadelphia, PA – October 20-21, 2011
Summary:

This presentation discusses the approach one should be thinking about when designing a Supply Chain Strategy. Specifically the slide deck refers to Risk Management and the relationship between Quality & Risk.

Some practical ideas are shared in relation to Quality Audits and how Risk Management can play an important role in this function.

Webinar: Aligning Quality Management Processes to Compliance Goals

This presentation covers the material presented on the Aligning Quality Management Processes to Compliance Goals Webinar.
Webinar – Thursday, February 23, 2012 9:00am
View the webinar on Aligning Quality Management Processes to Compliance Goals

Panelist Information: Nigel Smart – Managing Partner, Smart Pharmaceutical Consulting & Vinay Bapna – Director of Product Marketing, MetricStream
Duration: 1 hour

This session discusses the enterprise-wide approach organizations can adopt to ensure quality management processes are aligned to regulatory compliance goals. It also covers the role technology can play to obtain a 360° view of its Quality Management processes for a sustainable compliance program.