Overview: This webinar will provide an overview of process validation for devices and pharmaceuticals.
While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its application to all medical products. They will better understand the importance of their role not only in maintaining the process but also in helping diagnosis and treatment of patients more consistent.
Why Should You Attend: Process Validation (PV) has been a widely discussed and debated "phenomenon" in FDA regulated industries for many years. Do you know what process validation is and how you would explain it to an "alien" from another industry? Now, this is not to mean that other industries do not practice process validation because they do. It is that in the manufacture of medical products, so much is at stake for the professional and their patient. It is imperative that medical products must perform consistently so that patients can be treated in a predictable manner to treat, cure, and diagnose disease.
Areas Covered in the Session:
* Defining IQ/OQ and validation and its role in maintaining product quality
* Roles and responsibilities in the validation process
* The process validation lifecycle from design to product discontinuation
* How about Process Analytical Technology (PAT)
* Similarities and Differences-Product and Process Design
* Similarities and Differences-Equipment and Facilities
* Similarities and Differences-Supplier and Component Consistency
* Protocol Approval Process for Installation & Operational Qualification and Process Validation
* Executing the Protocols
* Reviewing the Issue Protocols, Taking Appropriate Actions, and Writing the Report
* Revalidation
Who Will Benefit:
* Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products.
* Interdepartmental functions associated with scaling up and commercializing a new medical product
* Regulatory Affairs
* Companies manufacturing combination products
* Suppliers and software vendors, servicing the FDA regulated industries, who want to better understand the customer's needs and requirements.
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its application to all medical products. They will better understand the importance of their role not only in maintaining the process but also in helping diagnosis and treatment of patients more consistent.
Why Should You Attend: Process Validation (PV) has been a widely discussed and debated "phenomenon" in FDA regulated industries for many years. Do you know what process validation is and how you would explain it to an "alien" from another industry? Now, this is not to mean that other industries do not practice process validation because they do. It is that in the manufacture of medical products, so much is at stake for the professional and their patient. It is imperative that medical products must perform consistently so that patients can be treated in a predictable manner to treat, cure, and diagnose disease.
Areas Covered in the Session:
* Defining IQ/OQ and validation and its role in maintaining product quality
* Roles and responsibilities in the validation process
* The process validation lifecycle from design to product discontinuation
* How about Process Analytical Technology (PAT)
* Similarities and Differences-Product and Process Design
* Similarities and Differences-Equipment and Facilities
* Similarities and Differences-Supplier and Component Consistency
* Protocol Approval Process for Installation & Operational Qualification and Process Validation
* Executing the Protocols
* Reviewing the Issue Protocols, Taking Appropriate Actions, and Writing the Report
* Revalidation
Who Will Benefit:
* Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products.
* Interdepartmental functions associated with scaling up and commercializing a new medical product
* Regulatory Affairs
* Companies manufacturing combination products
* Suppliers and software vendors, servicing the FDA regulated industries, who want to better understand the customer's needs and requirements.
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
