What is covered in Cleaning Validation Training?
The training includes worst-case product selection, MACO/PDE limit setting, swab/rinse sampling techniques, and guidance on developing cleaning validation protocols.
Is this training aligned with regulatory expectations?
Yes, the training aligns with ICH, WHO TRS, PIC/S, and FDA guidelines on cleaning validation for GMP environments.
Do participants receive any templates or documentation?
Yes, we provide SOP and protocol templates, example reports, and regulatory references for practical use.
Can this training be delivered virtually?
Absolutely. We offer on-site, virtual, and hybrid modes to suit your team’s needs.
Who should attend this training?
QA/QC personnel, validation engineers, manufacturing supervisors, and compliance managers are ideal participants.
What topics are covered in the cleaning validation training?
Our training covers worst-case product selection, MACO and PDE limit calculations, swab and rinse sampling methodologies, and protocol/report development, with hands-on case studies for GMP-aligned application.
Who should participate in this training program?
The program is ideal for manufacturing, QA, and validation teams involved in GMP-compliant cleaning processes, seeking to ensure compliance and prepare for regulatory audits.
How does the training ensure regulatory compliance?
Our training aligns with ICH Q7, PIC/S PI 006, WHO TRS 1019, FDA Cleaning Validation Guidelines, and EU GMP Annex 15, ensuring your team meets global regulatory standards and audit requirements.
What materials are provided during the training?
Participants receive training materials (PDF/PPT), a certificate of participation, template SOPs and protocols, case studies with hands-on examples, and regulatory reference guides.
Can the training be customized for our facility’s needs?
Yes, our training is tailored to your facility’s specific cleaning validation needs, focusing on processes like equipment qualification or multi-product facility compliance for practical outcomes.
What delivery formats are available for the training?
We offer flexible delivery options, including on-site, virtual, and hybrid formats, designed to accommodate your team’s preferences and ensure seamless learning experiences.