This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records.
The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what is meant by "list of components", the session will cover attachments and documentation expectations. Finally, the webinar will review the process and requirements for issuance and handling of Batch Production Records (BPR), and clearly describe the difference between the master and the batch production record.
Why Should You Attend: All the requirements for the master production record (MPR) are based on relevant US and EU regulations. Failure to recognize and implement those requirements can have devastating effects on your company's quality system, including production and manufacturing controls. The purpose of this webinar is to provide attendees with the mandatory compliance requirements for the master production records. Applicable areas may include clinical, technology transfer, and routine manufacturing and packaging for the API and finished commercial product. It is the intent of this program to enable your firm to have a consistent, compliant approach and maintain continuous improvement in the area of production records. With the information gained from this presentation, your company's policy or standard for MPR's will comply with the regulations, and you can be assured that you will be working within the intent of and meeting these regulatory requirements. Most importantly, by complying with these regulations, you are ultimately helping to provide a better product for your patients.
Areas Covered in the Session:
Who Will Benefit:
- Regulatory Expectation (FDA and EU)
- Creation and Revision of Master Production Record (MPR)
- Review and Approval of MPR
- Content of the MPR
- Issuance of BPR
- Device Master Record (DMR)
- Roles and Responsibilities
- Manufacturing (production and packaging)
- Quality Assurance
- Materials Management
- Quality Control
- Regulatory Affairs