New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines
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The deadline for implementation of the new elemental impurities guidelines for drug products and ingredients is fast approaching. Implementation is scheduled for January 2018, by which time manufacturers of pharmaceutical drug products must comply with
USP <232>/<233> and ICH Q3D.
A new, dramatically different requirement for elemental impurities is applied for most pharmaceutical products. These requirements cover more metals and require lower limits than the antiquated Heavy Metals test. Additionally, the analytical technique, ICP-MS, is much more challenging. By attending this course you will learn about the new requirements and also about using risk assessment to minimize unnecessary testing and meet FDA expectations.
Objectives of the Presentation
The subject is of importance to the manufacturers of new drug products as they will be required to comply with the new elemental impurities standards either through thorough risk assessments or through testing as new regulatory submissions are made, and to manufacturers of existing products as they make decisions regarding the extent of risk assessment and testing required to demonstrate compliance with the new standards. If the manufacturer's compliance strategy involves testing, there are many things to consider regarding the selection of the correct analytical technique (e.g., atomic absorption, ICP emission spectroscopy, ICP mass spectrometry).
The objective of this live training webinar is to provide an understanding of the new standards and guideline, what testing is required in order to comply with the spirit of the documents, how to perform a proper risk assessment, and how to perform suitable analytical measurements.
Areas Covered
A new, dramatically different requirement for elemental impurities is applied for most pharmaceutical products. These requirements cover more metals and require lower limits than the antiquated Heavy Metals test. Additionally, the analytical technique, ICP-MS, is much more challenging. By attending this course you will learn about the new requirements and also about using risk assessment to minimize unnecessary testing and meet FDA expectations.
Objectives of the Presentation
- How the new FDA Guidance on Elemental Impurities is related to ICH Q3D and USP Chapters 232 and 233
- What drug products are within the scope of the guidance
- Which classes of drug products need to comply with ICH Q3D and which with USP 232/233
- How risk assessment influences what testing is required
- What documentation related to control of elemental impurities is expected by FDA
- Which procedures can be used to demonstrate compliance
- How methods should be validated
The subject is of importance to the manufacturers of new drug products as they will be required to comply with the new elemental impurities standards either through thorough risk assessments or through testing as new regulatory submissions are made, and to manufacturers of existing products as they make decisions regarding the extent of risk assessment and testing required to demonstrate compliance with the new standards. If the manufacturer's compliance strategy involves testing, there are many things to consider regarding the selection of the correct analytical technique (e.g., atomic absorption, ICP emission spectroscopy, ICP mass spectrometry).
The objective of this live training webinar is to provide an understanding of the new standards and guideline, what testing is required in order to comply with the spirit of the documents, how to perform a proper risk assessment, and how to perform suitable analytical measurements.
Areas Covered
- Elemental Impurities: The case for change
- Overview of Guidance Documents: FDA, ICH Q3D, USP 232/233
- Scope of the guidance's
- Risk Assessment
- FDA Recommendations
- Controls and Documentation
- Analytical Procedures and Validation
- What you should be doing now
- Researchers/ R&D Mangagers
- Laboratory Managers/ Directors / Supervisors
- Laboratory Technicians / Operators
- Analytical Chemists
- Laboratory Managers
- Regulatory Compliance Managers
- Quality Control and assurance managers
- Chemical Manufacturing and Control managers
Schedules
May 15, 2018
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Onlinecompliancepanel is a dedicated team of youngsters, who work in tandem with the latest US FDA regulations/regulatory compliance in creating training sessions suitable for individuals and corporations. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Our interactive training sessions could be beneficial to corporations thriving in industries such as pharmaceuticals, drugs and chemicals, FDA compliance, medical devices, packaging and labeling, food and beverages, banking and finance, audits and inspections, recalls and crisis management and many more. We emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices, risk management and market trends.
Professional training, in the essential quality disciplines, contributes to both the competitiveness of your business and also to personal motivation; it broadens the experience and accelerates the development of those who participate. We provide training in a number of ways: ...
Professional training, in the essential quality disciplines, contributes to both the competitiveness of your business and also to personal motivation; it broadens the experience and accelerates the development of those who participate. We provide training in a number of ways: ...
