Creating Material, Waste, and Personnel Flow Diagrams for Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel

Overview: This live webinar concentrates on identifying and discussing flow requirements associated with cleanrooms.

We will explore the typical flows used in cleanrooms and controlled environments for material, waste and personnel. The webinar also discusses implementation and management of these flows based upon tried and true industry practices, guidelines, and standards. The key benefits of this course are:
In-dept understanding of Personnel/Material/Waste Flow management.
Achieve satisfactory inspections more easily.
Higher assurance of new medical product approvals.
Minimize nonconformances.
Reduce rates of batch rework and rejections.
Reduce product contamination issues.
Avoid product recalls.
Why should you attend: cGMP regulations require that medical product manufactures define and control movement of materials, personnel, and waste to reduce the likelihood of mix-ups and contamination. Cleanrooms and controlled environments add layers of complexity to flow concerns and need to have special consideration in order to meet regulatory expectations and contamination control requirements. In fact, flow diagrams are typically requested as part of regulatory applications and need to be established based upon product requirements. Therefore it is important to properly design and create flow diagrams to ensure best practices are followed.

Areas Covered in the Session:
Identify regulatory expectations regarding Personnel/Material/Waste Flow.
Identify “nomad” personnel and how they impact your control of flow.
Examine flow diagrams and procedures.
Identify special situations which need to be addressed in flow procedures.
Discuss personnel training, signs, and labels.
To identify SOPs and documentation.

Who Will Benefit:
QA managers and personnel
Regulatory affairs
Operations managers
Engineers
Validation professionals
Microbiologists
Consultants
Facility Engineers

Charles Gyecsek is formerly of Hoffman LaRoche where he worked primarily in Validation, Microbiology, Quality, and Operations. During his career Charles set-up and managed one of the largest GMP cleanroom facilities in the US, encompassing more than 200 rooms in 3 separate facilities. Charles' extensive experience involves plant start-up, cleanroom design and renovation, quality system auditing, regulatory submission writing, microbiology, equipment and cleaning qualification, utility validation, water system design and validation, aseptic processing, risk management, and regulatory inspections and responses.

Charles is currently president of MIJ Enterprises whose Compliance Division provides personalized consulting and training services within FDA regulated industries pertaining to pharmaceuticals, diagnostics, devices, and biotech products. Their core mission is to help clients maximize the benefit of a quality system in order to provide innovative products and exceptional services to their customers.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00