Don’t let the risk of contamination ruin your company’s business. Turn to the trusted cleanroom specialists at Sure-BioChem Laboratories, LLC, in Camden, New Jersey. Our staff offers full-service cleanroom training to help your employees know how to handle any contaminations.
When it comes to contamination control, have the best response practices available. These practices are an essential element of working within cleanroom environments and are vitally important to many industries. Our training emphasizes the goals of creating a thorough core understanding of the impacts contamination has on a cleanroom.
Our training creates a fundamental awareness and understanding amongst personnel as to how they, and their processes, behaviors, methods, and practices contribute to contamination. We also teach how to minimize and prevent contamination levels.
Address Issues in the Cleanroom
Cleanroom Clothing and Gowning Practices
Controls to Minimize Contamination During Setup
Rolling Out Changes in Policies and Procedures
Effective Cleaning of Surfaces and Equipment
Ensuring a High Standard of GMP
Implementing a Preventative Action Process
Improving Current Standards
Seeking External Opinion and Independent Feedback
Monitoring and Measuring the Performance of the Cleanroom
Personal Behavior and Hygiene
Preparing Staff for Regulatory Body Audits
Supporting Root Cause Analysis
Transfer of Materials into the Cleanroom
Human Error, Quality Events & Process
A GMP Approach to the Detection, Correction & Prevention of Human Errors.
ICH Q8, Q9 & Q10 as a Preventive Quality Tool in the Pharma Industry.
An FDA Regulatory Perspective to Training Effectiveness
An FDA Regulatory Approach to Six Sigma for Business Excellence.
Meeting FDA and GMP Requirements
Data Integrity in Microbiology and Chemistry Laboratories.
Computer System Validation (CSV)
Electronic Records; Electronic Signatures (21 CFR Part 11)
Who Should Attend
Any person in the organization or service sector involved in working with cleanroom environments will find our training useful. Some of our main clients include:
Prior to organizing an in-house training program, we conduct a cleanroom audit to examine any specific problems or issues that are in your cleanroom. Our facilitator is able to then tailor the training program to suit your needs.
A detailed report featuring observations, suggestions, and recommendations is submitted to you as to how the standard GMP can be improved. Any suggestions or changes adopted by you can then be implemented as a standard element of your on-going training program.
Afterwards, a follow-up audit can be conducted to make sure the recommended modifications in control practices are being properly implemented. We offer ongoing guidance and support as part of our maintenance services.
Contact us to hire our cleanroom team for all your cleanroom cleaning and training needs.