Projects

cGMP biotech development and pilot plant

Read how NNE set up a risk- and science-based verification system for UCB Pharma’s GMP-compliant facility for biomanufacturing.

Projects

Quality strategy for biopharmaceutical manufacturing

Read about the quality and verification principles behind it.

Projects

Validation transformation from C&Q to ASTM E2500

NNE helped streamline Pfizer's verification systems.

Services

Independent and tailored medical device testing | NNE

We cover all facets of testing, ranging from feasibility/explorative testing to full design verification testing using validated test methods, based on three key elements: First-hand ISO standard and device test regulatory knowledge Complying with standards is rooted in our DNA. Hence, we can provide an independent verification of the device performance. We support your device development process from early feasibility testing through...

TechTalk

Data-based road map to continuous control strategy and real-time release | TechTalk

  Many pharmaceutical manufacturers are working towards continued process verification to live up to health authority expectations. Verification is a passive act, where the process is estimated to live up to specifications without any adjustment of process parameters. Ideally, it is best to have continuous process verification and control where process parameters are adjusted to keep processes on target. To achieve this ideal state, the...

TechTalk

The value of control strategy for legacy products | TechTalk

No matter the established success of a pharmaceutical product, regulatory authorities still expect continued process verification of these hot drugs. However, health authorities expect companies to perform continued process verification (CPV – stage 3) on these legacy products regardless of their lengthy establishment. The 3-step process continuous process verification .

Statistical process control (SPC), MSA and capability 2

Your benefits After participating in this course, you will be able to  Decide on a sufficient sample size for data-based decisions Link acceptance quality limit AQL with severity risk and verification level Understand why AQL based ISO sampling plans do not make sense Perform a measurement systems analysis with inhomogeneous variance Use the right control chart for different scenarios and data set e.g. non-normal distributed data, attribute...

TechTalk

The missing link of single-use implementation

Operators must be trained in handling and assembling tube sets and verification of connection integrity to prove system closure. Regardless of what is chosen, there is importance in how the connection verification is documented and how both the identification of components and a proper set-to-set interface is verified.

TechTalk

Statistical process control: is it the right business strategy for you?

 Statistical process control is a great business strategy to consider if your company is experiencing one or more of the following issues: Variation in yield or product quality Random component errors Verifying effect of error correction Anchoring optimization projects Meeting recent regulatory requirements regarding process verification Where to begin?

Services

Tailored drug delivery services | NNE

As such, a wealth of consulting and engineering services to support your drug delivery programme: Consulting Development of project management models and technology development models Project portfolio management Tolerance chain analysis Front-end innovation: Human factors engineering/usability studies, user studies, idea generation, industrial design, concept development and selection General risk management consulting Design review CMO searc...