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5213 Compliance for Biopharmaceutical API Process Validation
Instructor:
» Mr. John Bennan
Next course:
June 1-3, 2009, Prague, Czech Republic
Course Venue:
» Andel's Hotel & Suites Prague
Agenda:
Day 1: 8.30-16.30 Registration 08.00-08.30
Day 2: 8.30-16.30
Day 3: 8.30-12.00 + Lunch
Price:
€ 1.895 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
» Mr. John Bennan
Next course:
June 1-3, 2009, Prague, Czech Republic
Course Venue:
» Andel's Hotel & Suites Prague
Agenda:
Day 1: 8.30-16.30 Registration 08.00-08.30
Day 2: 8.30-16.30
Day 3: 8.30-12.00 + Lunch
Price:
€ 1.895 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
Industry field:
Biopharmaceutical industry
Course description:
Firms manufacturing biotechnology-derived pharmaceuticals face special requirements in the validation of their processes and rigorous scrutiny from Regulatory Agencies that are well aware of the extent to which the process defines the product in this field. This course reviews and interprets the specific regulatory requirements, provides examples of the required documentation, and discusses current industry trends and regulatory hot topics.
One of the recent FDA initiatives is to incorporate quality by design during product development. A rational approach is presented to include consideration for Process Validation in all aspects of development. Special emphasis is given to parameter selection and evaluation, such as determining criticality, how to set valid ranges and when to use worst case studies.
Course outline:
• Regulatory Requirements and Compliance Overview
• Evaluating Critical and Non-critical Process Parameters
- Current GMP and FDA requirements
- Capturing Data
- Determining Critical Parameters
- Process Characterization
- Setting Ranges
• Class Exercise: Evaluating Data to Assess Critical, Key and non-Key Parameters
• Quality by Design: Lab Bench to Market Production
- Considerations for Process Development
- Considerations for Analytical Laboratories
- Tolerances and Uncertainties
- Technology Transfer
- Quality Assurance Involvement
• Process Validation Support Studies
- Genetic Stability
- Process- and Product-Related Impurity Removal
- Viral Clearance/Inactivation
- Process Intermediate and Buffer Hold Times
- Chromatography and Membrane Cleaning, Storage & Reuse
- Evaluation of Materials
• Case Study: Determining Process Intermediate Hold Times
• Current FDA Issues and Hot Topics
Learning objectives:
This course is designed to provide a basic overview of issues and compliance requirements specific to validating a biopharmaceutical manufacturing process. Attendees will learn critical elements for review and/or inclusion in Process Validation documentation including protocols and reports.
Who should attend:
Personnel in Development, Manufacturing, Validation, QA, and QC involved in Process Validation and process control should attend. Course assumes the attendee has a basic understanding of the GMP regulations.
Biopharmaceutical industry
Course description:
Firms manufacturing biotechnology-derived pharmaceuticals face special requirements in the validation of their processes and rigorous scrutiny from Regulatory Agencies that are well aware of the extent to which the process defines the product in this field. This course reviews and interprets the specific regulatory requirements, provides examples of the required documentation, and discusses current industry trends and regulatory hot topics.
One of the recent FDA initiatives is to incorporate quality by design during product development. A rational approach is presented to include consideration for Process Validation in all aspects of development. Special emphasis is given to parameter selection and evaluation, such as determining criticality, how to set valid ranges and when to use worst case studies.
Course outline:
• Regulatory Requirements and Compliance Overview
• Evaluating Critical and Non-critical Process Parameters
- Current GMP and FDA requirements
- Capturing Data
- Determining Critical Parameters
- Process Characterization
- Setting Ranges
• Class Exercise: Evaluating Data to Assess Critical, Key and non-Key Parameters
• Quality by Design: Lab Bench to Market Production
- Considerations for Process Development
- Considerations for Analytical Laboratories
- Tolerances and Uncertainties
- Technology Transfer
- Quality Assurance Involvement
• Process Validation Support Studies
- Genetic Stability
- Process- and Product-Related Impurity Removal
- Viral Clearance/Inactivation
- Process Intermediate and Buffer Hold Times
- Chromatography and Membrane Cleaning, Storage & Reuse
- Evaluation of Materials
• Case Study: Determining Process Intermediate Hold Times
• Current FDA Issues and Hot Topics
Learning objectives:
This course is designed to provide a basic overview of issues and compliance requirements specific to validating a biopharmaceutical manufacturing process. Attendees will learn critical elements for review and/or inclusion in Process Validation documentation including protocols and reports.
Who should attend:
Personnel in Development, Manufacturing, Validation, QA, and QC involved in Process Validation and process control should attend. Course assumes the attendee has a basic understanding of the GMP regulations.
Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com