Webinar: Cleaning Validation

"Cleaning Validation in the Pharmaceutical Industry - Dealing with Spot Contamination"

Cleaning validation is documented evidence that an approved cleaning process reproducibly reduces the precursor product or cleaning agents used in equipment below the scientifically established maximum permissible residue level."

[EU GMP Directive 2015, Annex 15].

Does your cleaning validation meet these requirements? Did you also consider possible spot contamination?

But what exactly is spot contamination?

Spot contamination assumes that chemical, microbial, or particulate contamination is present locally and will be distributed not homogenously during further production. This can make products a safety risk for patients or lead to the loss of the entire batch.

To ensure product safety and prevent batch loss, Valicare conducts a risk-based assessment of all types of contamination and critical areas prior to cleaning validation.

In addition to transition points and filling areas, the filling technology for liquid products (e.g., filling needles) or the tablet press /capsule filling machine for solid dosage forms will be focused on as possible hot spots.

Why to take part at our webinar?

Have you already had experience with spot contaminations? Or would you like to find out more in advance to minimize the risk to your products and your company?

Join our webinar, update your knowledge of cleaning validation, and ask our senior GMP expert, Dr. Carsten Börger, your questions.

What can you expect from our webinar?

After a brief introduction to cleaning validation, product and equipment bracketing, and the determination of limit values, we will focus on spot contamination:

Key Topics We’ll Cover:

✅ Sources of spot contamination

✅ Why spot contamination should be considered

✅ Risk assessment and worst-case scenario at spot contaminations

✅ Setting limit values while considering spot contamination

✅ Analytical methods and detection of spot contamination

✅ Corrective and preventive actions (CAPA) for spot contamination

✅ Questions & Answers

🤱 Who should Attend?

✅ Specialists and managers for whom the topic of cleaning validation is relevant.

✅ Technicians, engineers, QA specialists, manufacturing management, qualified person.

❔ Why you should participate:

Fresh up our knowledge base in cleaning validation and learn about the risks of spot contamination. In addition, find out what measures you can take to ensure the safety of your products.

🥇 The quality of your products ensures you the trust of your customers.

Our webinar will be held in German and English and will take place on the following dates.