Risk Management in (FDA) Quality and Manufacturing Areas – Understanding What the Regulators Expec (FDA Compliance)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Dec 15, 2011 End Date/Time: Dec 15, 2011
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The presentation will highlight the importance of complete documentation, not just to satisfy the agency during product review and inspection, but also as a permanent record for decision making in the future. The speaker will describe the importance of clear communication to assure focused decision making and buy off in the organization.

Areas Covered in the Seminar:

- Why Risk Management techniques are critical in both development of product and processes and also manufacturing operations and their controls?
- Where these techniques can be used in everyday operations?
- The major elements of the Risk Management process from initiation, through risk assessment and control to implementation, review and communication.
- The methodology for risk identification, quantification and prioritization.
- How Risk Management integrates and become an important element of Continuous improvement and your Quality Management System?
- What the agencies expect from you when you use the techniques?

Who Will Benefit:

This webinar will provide valuable assistance to all companies that manufacture and develop products in pharmaceutical and biotech industries. The employees who will benefit include:

- Quality Assurance
- Quality Control
- Regulatory Compliance
- Regulatory Affairs
- Engineers
- Facility Design and construction


Online Event
2600 E. Bayshore Road
Palo Alto
United States