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View Sub-Track: Sessions on Regulatory

Thursday, March 04, 2010

Automating the Regulatory Compliance & Quality Assurance Areas
Room: 202B ~ 1:45PM - 3:15PM (Thursday, March 04, 2010)

Sponsored by ISPE:

The new technologies to be covered in the presentation focus on tools to comply with parts: 11, 820, 211, and 600 which covers pharma as well as medical devices, but will better serve industries that need to comply with new regulations since their use will save money on implementation of new regulatory and compliance requirements which are being impacted by the changes.

This topic should have special interest for those companies who have to comply with new regulations and those who would like to improve their efficiency and lower the cost of keeping their operations in compliance

This seminar will cover the application of coming technologies that will be available for the regulated industry to be in compliance with the 2009 current Good Manufacturing requirements. The new technologies will manage the regulatory aspects, providing a cross link in the documentation control necessary to be in compliance with the new 21 CFR part 11, 820, 211 and 600. New software applications can integrate all relevant requirements and activities necessary to manage in secure databases all different regulatory aspects from the planning, scheduling, implementation, execution and final electronic approval of the documentation in different areas. Several of these areas can be studied and evaluated in an interactive workshop using new technology software database applications that will be released soon:

1. Compliance Level: 21 CFR Part 11, 211, 820 & 600
2. Master Formulas & Manufacturing Instructions
3. Standard Operating Procedures
4. Design Specifications
5. Training Records
6. FDA Submissions
7. Annual Product Review
8. Laboratory of In-Process/Finished Products
9. Laboratory of Raw Materials
10. Laboratory Packaging Components
11. Laboratory Microbiology & Sampling
12. Laboratory of Stability
13. Experimental Projects and Pilot Lots
14. Validation Protocols
15. Media Fills
16. Calibrations and ISO 13485 compliance
17. Re-processing and Non-Conformance
18. CAPA’s, Deviations and Investigations
19. Complaints
20. Returned Goods
21. Recalls
22. QA Audits and Quality Assessments
23. Change Control
24. Retained Samples
25. Advanced Statistics
26. Advanced Custom Reports
27. Manufacturing Scheduling
28. Engineering & Preventive Maintenance
29. P&ID’s Manager
30. Work Orders Manager

Speaker:

Ramon Cayuela Melendez - Vice President, Computer Integration of Quality Assurance

Developing a Close Loop System for Reporting Failure Investigations and Process Deviations
Room: 203 ~ 1:45PM - 3:15PM (Thursday, March 04, 2010)

This presentation highlights FDA requirements and quality assurance overviews on how to document the results from your failure investigation This presentation provides clarification on the scope of relevant guidance and the essential skills necessary to ensure compliant documentation. Attendees will examine each step of an effective investigation and learn what documentation is required along the way, such as Root Cause Analysis and CAPA and explore FDA expectations regarding CAPA. Additionally, participants will learn to avoid common obstacles to success and practice conflict resolution skills. This presentation outlines tips and techniques to improve failure investigations and identifies proposed corrective action which ensures successful implementation and closeout. Review FDA Expectations for Failure Investigations and Process Deviations Explore GMP and GXP regulations related to process failures and process deviations Review general industry practices for failure investigations and process deviations Discuss FDA expectations regarding failures and process deviations Describe types of 483's issued for investigations Identify common barriers and pitfalls Identify tips for resolving conflicts Explore Different Types of Reports Develop procedures for completing failure investigations and addressing deviations Review deviation or incident reports Create nonconforming material reports Review how to solve (OOS) results Discuss validation failures Address change control and traceability with the reports Identify what information should be captured for each type of investigation Identify Key Steps for Effective Summary Report Writing Assign each report a unique identification number to ensure traceability Outline what must be documented Identify the main components of the report Introduction/Summary of the Incident Summary of Steps of Investigation (Root Cause Analysis) Evaluate the Overall System for Investigating Failure and Process Deviations Outline team responsibilities Review key investigational tools Examine how each component fits within the CAPA system Follow up on CAPA issues related to deviations and ensure closure

Jackelyn Rodriguez - President, Monarch Quality Systems Solutions

Friday, March 05, 2010

FDA Priorities and Outlook for 2010
Room: 202C ~ 9:00AM - 10:30AM (Friday, March 05, 2010)

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