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The Trainer
Vinny Sastri
President, WINOVIA® LLC |
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| Who Will Benefit: |
- Upper management
- Quality leaders and managers
- Research and development managers and personnel
- Manufacturing managers and engineers
- Clinical personnel
- Sales and marketing managers
- Regulatory managers
- Purchasing managers
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| Trainer Profile : |
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Dr. Vinny Sastri is the President of Winovia LLC, a consulting company that provides customized, sustainable solutions, strategies and training in new product development, quality improvement and high performance materials. Dr. Sastri specializes in design controls, process validation, good manufacturing practices and risk management. Dr. Sastri has over a decade of experience in the healthcare and medical device industry. He has been invited to many conferences to speak about new product development, high performance materials, Design for Six Sigma, Quality and the FDA Quality Systems Regulations. |
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How To Comply With FDA Quality Systems Regulations And Pass FDA Inspections
As part of Global Compliance Series of seminars, ComplianceOnline brings you the expert view on “How To Comply With FDA Quality Systems Regulations And Pass FDA Inspections” by Dr. Vinny Sastri is the President of Winovia LLC, a consulting company that provides customized, sustainable solutions, strategies and training in new product development, quality improvement and high performance materials.
Developers, manufacturers, distributors, relabelers, repackagers, or exporters of an FDA regulated product to the United States (pharmaceuticals, biologics, clinical trials, medical devices, cosmetics, food etc.), you must be prepared for FDA inspections. Companies must be knowledgeable of and in compliance with FDA laws, regulations, and guidelines such as Current Good Manufacturing Practices (cGMP's), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and relevant Quality Systems Regulations. This course is geared towards all such organizations. It will cover the objectives of FDA inspections and the inspection process itself. Participants will learn the key elements that will allow them to comply with the regulations and pass the inspections. Case studies will highlight important aspects of the inspections and regulations.
OUTLINE OF 1-DAY CONFERENCE
| SESSION - 9:30 AM - 5:30 PM |
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- Introduction and Applicability
- Objectives and purpose of FDA regulations
- Understanding which companies need to comply
- Important definitions
- FDA Inspections
- Purpose and objectives of inspections
- Types of inspections
- The inspection process
- Warning letters and 483s
- Responses to warning letters and 483s
- Quality Systems and Management Responsibility
- What is a quality system?
- Purpose of a quality system
- Quality policy
- Importance of document controls (procedures, objective evidence)
- Importance of management responsibility
- Organization, personnel, training
- Audits
- Management reviews
- FDA Inspection of quality systems and management responsibility
- Design and Development
- Importance of understanding user needs
- Human factor studies
- Importance of design controls and applicability
- Design controls basics
- FDA inspections of design and development
- Manufacturing
- Current good manufacturing practices (cGMPs)
- Identifying essential components and process controls
- In-coming materials, in-process components and finished product
- Packaging and labeling
- Process validation basics
- Material/purchasing controls
- Facilities and equipment controls
- Good Lab Practices (GLP)
- Good Clinical Practices (GCP)
- FDA Inspections for good manufacturing practices
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- Importance and significance of risk management
- ISO 14971 – Risk Management Guidance Document
- Risk management techniques (FMEA, Fault tree analysis etc.)
- Embedding risk management into an organization
- Corrective and Preventive Action (CAPA)
- Objectives and purpose
- Sources of information
- Non-conformance
- Complaint handling
- CAPA process
- CAPA and management reviews
- Continuous improvement
- FDA Inspection of CAPA
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Price INR* |
Savings |
15th October, 2007 |
13,000 |
3,000 |
30th October, 2007 |
14,000 |
2,000 |
Final Week |
15,000 |
1,000 |
On Site |
16,000 |
0 |
| * Price does not include taxes. 12.36% taxes will be included in final amount. |
Cancellation Policy
Requests for cancellations or date transfers need to be received at least Seven (7) business days prior to the event in order to receive a 25% refund. If a cancellation or reschedule request is received less than Seven (7) business days before the start date, the penalty of 100% of the cost will be applied. Refunds will not be allowed for "no-shows". If your plans should change, you may designate a substitute to attend in your place at any time. This cancellation policy is strictly enforced.
Cancellation Liability
CO reserves the right to cancel events for any reason at anytime. Cancellation liability is limited to the return of payment ONLY. CO will not reimburse registrants for any travel cancellation fees or penalties, including airfare and hotel.
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