Understanding Proper Application of Risk Assessment
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
2011 FDA Guideline on Process Validation
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
2011 FDA Guideline on Process Validation
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Similarities and Differences Between an FDA and MHRA Audit
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
2011 FDA Guideline on Process Validation
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Understanding Proper Application of Risk Assessment
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Similarities and Differences Between an FDA and MHRA Audit
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Validation Master Planning and Regulatory Expectations
Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
2011 FDA Guideline on Process Validation
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Understanding FDA's Quality Metrics Draft Guidance and Its Impact
To gain insight with regard to future expectations of the FDA with regard to quality metrics. Since the publication of the draft guidance there have been independent studies performed on behalf of the FDA.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Understanding FDA's Quality Metrics Draft Guidance and Its Impact
To gain insight with regard to future expectations of the FDA with regard to quality metrics. Since the publication of the draft guidance there have been independent studies performed on behalf of the FDA.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Validation Master Planning and Regulatory Expectations
Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
2011 FDA Guideline on Process Validation
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Similarities and Differences Between an FDA and MHRA Audit
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
2011 FDA Guideline on Process Validation
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Validation Master Planning and Regulatory Expectations
Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Introduction to Risk Assessment
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Establishment of Quality Systems
Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.
Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Building Quality Systems for Pharmaceutical and Medical Device Firms
Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.
Speaker: Louis Angelucci | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Introduction to Risk Assessment
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
Speaker: Louis Angelucci | View Anytime | Duration: 90 Minutes | Price: $145.00 | View Details
Validation Master Planning and Regulatory Expectations
Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.
Speaker: Louis Angelucci | View Anytime | Duration: 90 Minutes | Price: $157.00 | View Details
Similarities and Differences Between an FDA and MHRA Audit
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
Speaker: Louis Angelucci | View Anytime | Duration: 90 Minutes | Price: $153.00 | View Details
Introduction to Risk Assessment
Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
Speaker: Louis Angelucci | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Establishment of Quality Systems
Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.
Speaker: Louis Angelucci | View Anytime | Duration: 60 Minutes | Price: $189.00 | View Details