2012 - Live webinar on Starting the Quality System From Scratch By compliance2go

Why should you attend?

This will provide considerable insight into how quality systems are constructed and operate to meet customer requirements. From these discussions, you will gain insight about how to actualize product and quality system improvements, as well to develop your own quality system.

Areas Covered in the seminar:

1. “Which comes first the alligator or the egg?”
2. Staffing & Training is key to success but be cautious of “foreign aid”
3. Planning the Quality System-It’s not just for quality anymore.
4. The Quality Manual & Technical Manual captures, organizes, controls and preserves
5. Facility Design and Maintenance
6. Equipment Design, Qualification, Calibration, Maintenance
7. Supplier and Contractor Qualification
8. Packaging and Labeling
9. Coordinating activities with Regulatory Affairs in the approval process.
10. Headquarters is coming for a visit.
11. Do not forget the laboratory.
12. Commissioning & Qualifying the Facility
13. Trial runs ,Scaling up, and Process Validation
14. The Pre-approval l Inspection ?but first get know the local FDA
15. In-Process Controls & In-Process Testing
16. The Laboratory

Who will benefit:

- Senior Management

- Warehousing

- Purchasing Managers and Procurement Managers

- Laboratory Analyst

- Cost Accounting

- IT

- Documentation Management

- Upper Management functional or departmental heads of Quality, Production and Operations, Research and Development, Sales and Marketing, Human Resources, and Finance

- Any member of a team involved in starting up, revamping, or remediating a quality system

This course is designed for all levels of quality experience.

For the beginner, the course provides a logical and graphical perspective, enabling them to understand how quality principles and quality subsystems relate to their role and responsibilities. They will better understand their current quality system.

For the intermediate & advanced, they will be able to apply what they have learned to contribute significantly to building or revising new quality systems. It will help them better manage quality, solve problems, improve internal auditing, and make quality system improvements.

The opportunity to design a quality system from scratch offers great rewards in experiencing and understanding the functions of quality systems. For me, this “dream” of building the “perfect quality system” began during my early quality management days as I learned and experienced quality system successes and failures. I learned from these thinking and dreaming, “If only I could set up my own quality system”.

Finally, this dream came true when I was given the opportunity to design and implement a combination pharmaceutical and medical device quality system from scratch. Since this first experience, I have designed and implemented several quality systems (including virtual) that have resulted in successful preapproval inspections. I have also revamped failing quality systems to make them more compliant and effective.

As you can imagine, starting from scratch and revamping failing systems is hard work, but the experience and knowledge gained is extremely valuable. The relationships built, both positive and negative, will last forever. I want to share these experiences with you so that you may gain insight about the hard work, expectations, pitfalls, and the rewards of starting a system from scratch.

About Speaker

Howard T. Cooper enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA.

His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations.

He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.