OEVENTS

OUR ROUNDTABLES

Roundtables mean exchange of experience. It is easy to find a lot of melodious theory and glossy papers. But what does really work and what does not, out in the real world? Which conditions do we need to check, before deciding for an approach? Our roundtables are fruitful and beyond the surface discussions with other practitioners. It is our job to make it a good conversation: fun, open, and most importantly, close to reality. We bring in our implementation experience and expertise. We understand that it’s our role to ask, “what did NOT work?”… And “how did you deal with different sources of resistance?”

Facing difficulties and overcoming them is what makes all of us learn. Why not sharing experiences and accelerate progress?

It is our passion to help improving!

Participants - Preparation - Schedule

Participants

  • 5-15 participants from different companies and industries

Preparation

  • Selection of topics most interesting for you
  • Confidentiality agreement and conditions for participation

Schedule

  • Short introduction into the topic to make sure everybody is on the same page
  • Based on our experience we prepare a catalogue of relevant and exciting questions to be discussed. Of course during the roundtable we are flexible to adapt topics to what is most interesting for you.
  • We facilitate an open discussion generating mutual understanding and exchanging examples from practice.
  • We bring in helpful approaches and best practice from a wide spectrum of companies.
  • For roundtables with more than 7 participants we will split the group in breakout groups to enable open exchange of experience within small circles of people

Useful instructions

Practice-proven solutions

Undocmatic approaches

Amazing, the challenges seem to be quite similar everywhere!

Great tips & tricks, very constructive and helpful

I have had great light bulb effects

Very agreeable: This is no consultant sales event…

This format is an unorthodox format, very refreshing

Jan 18 2021
13-16:00 CET

Online Meeting
free

ONLINE ROUNDTABLE PROCESS VALIDATION
in Pharma

Safe Quality through valid processes and smart statistics

Quality Assurance makes sure to have in place the right processes for drug production: It is challenging to set up the paperwork according to GMP and FDA requirements. What is more, Quality Assurance has to guarantee that the real work reflects the documentation. A seamless cooperation of Quality Management, Quality Assurance, Process Development, Sourcing and Supplier Qualification is mandatory – and still not common practice. Attend our roundtable to find out how other companies move forward to master these challenges.

Details

Who?

  • Quality Heads
  • Quality assurance, Qualified persons
  • Manufacturing Science and Technology
  • Auditors
  • Site Heads
  • Process development experts

Agenda:

  • Quick round of introduction
  • Introduction into the main topics (main topics are selected according to participants’ interest per pre-evaluation)
  • Exchange of Best Practice, discussion of difficulties & specific challenges
  • Useful systematic approaches
  • Feedback

Selection of topics:

  • Overview of relevant EU and FD guidelines with reference to the topic
  • Consistency of processes for systematic quality assurance: From raw material order to delivery. How to make sure Purchasing, Supply Chain, CMC and Quality Assurance do cooperate smoothly?
  • The entire Pharmaceutical Industry is set-up to for risk-based approaches. How representative are these results for the actual risk, and how to translate this into robust process control? The FDA demands here meaningful statistics which even leads to economic advantages. Let’s review which approaches are in place.
  • Topic Sample Size: How to build on process analysis for systematic risk assessment deriving from this sample sizes in sub processes? And which statistical approaches are useful?
  • From risk analysis to parametric validation in production: How is theory, how is real life?
  • Do you really live the formalized processes? A method is valid only if everybody sticks to the rules. How is Quality Assurance fulfilling its task to uncover process gaps? Which measures and indicators are appropriate for QA to work with and how is Quality Control using these measures?

For more information about Process Validation and our consulting approach please click here.

Feb 11 2021
13-16:00 CET

Online Meeting
free

ONLINE ROUNDTABLE OVERALL EQUIPMENT EFFECTIVENESS – OEE

Work, manage and improve building on OEE

OEE is one of the most fashionable metrics in Operations and there is probably no other metrics which is being substantially misused more. OEE triggers behavior, and details on setting up measurement and calculation matter a lot! OEE is a management metric: However, it requires quite a lot of experiences to build on to take valid decisions. Last but not least OEE is made to manage performance improvement. Exchange experiences with other participants to pick up new ideas and heads-ups.

Details

Who?

  • Site heads
  • Head of production
  • Head of maintenance and technical department
  • Process Optimization
  • Operational Excellence

Agenda:

  • Feedback
  • Quick round of introduction
  • Introduction into the main topics (main topics are selected according to participants’ interest per pre-evaluation)
  • Exchange of Best Practice, discussion of difficulties & specific challenges
  • Useful systematic approaches

Selection of topics:

  • Which decisions to take based on OEE and which decisions NOT to take
  • Challenges, difficulties, and risks when working with OEE
  • OEE – Metrics to show on which hierarchical levels
  • Working with sensor-based software or reading the machine control units: How to work in target-oriented ways with OEE?
  • The details: How to set-up OEE calculation? For example, how to consider quality problems that become obvious only in goods leaving inspection – too late? How to consider the maximum output rate: Do you build rather on manufacturer specification, on validated numbers or on actually proven maximum performance?
  • How to set-up management of improvement based on OEE?
  • What are typical business cases related to OEE?
  • Advantages and cardinal mistakes when using OEE in global operations to compare sites

OUR PAST EVENTS

Dec 10 2020
13-16:00 CET

Online Meeting
free

ONLINE ROUNDTABLE OPERATIONAL EXCELLENCE

Achieving results through Operational Excellence

Operational Excellence programs are omnipresent. What works best to achieve results and how are goals being set in different organizations? Do training programs reflect the needs of your organization and lead you where you want to get? Discuss these topics with participants from other companies and regions.

Details

Who?

Agenda:

  • Quick round of introduction
  • Introduction into the main topics (main topics are selected according to participants’ interest per pre-evaluation)
  • Exchange of Best Practice, discussion of difficulties & specific challenges
  • Useful systematic approaches
  • Feedback

Topics:

  • Increased output, more Quality, decreased Costs, smarter utilization of equipment and improved customer care: How to achieve measurable results with Operational Excellence and how important is this for our organization?
  • Leadership style contributes a lot to how much one can achieve with methods from the Operational Excellence toolbox. What do leaders need to be empowered for, to understand, and to do? And, how to support this?
  • Regarding capability building: Rarely “The more the merrier” is applicable. Much more matters a good selection of people. So, how to set-up for selecting the right people and what works best regarding training approach?