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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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December 06, 2012 |
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ComplianceOnline, Online Event
2013-01-11
Course Description:
Regulatory bodies are demanding more strict regulations for the biopharmaceutical industries due to the potential adverse effects of biopharmaceutical products. This webinar will discuss about the biopharma industry best practices to comply with the regulations. It will also cover the recent regulatory updates and practical GMP tips on how pharmaceutical and biopharmaceutical companies can ensure their quality systems are in control and in compliance with agency expectations.
Course Objective:
With an increase in FDA warning letters and 483s, it is critical that all manufacturers must know the up to date compliance regulation on biopharmaceutical products in order to avoid non conformances. Regulatory agencies are seeing in to quality system during the License Renewal Inspections, Cause Inspections, System Based Inspections and Pre-approval (PAI) Inspections. Quality system is mandatory to all regulatory agencies across the globe if you want to market your medicinal products including pharmaceutical and biopharmaceutical. This webinar will train you in one of the eight major modules of ASQ cGMP Certification Training Program for Pharma and Biopharma. This webinar will help the attendees to understand the regulatory involvements and laws associated with the Pharma and Biopharma quality systems.
Following areas are covered during the webinar:
1. Quality Management System (QMS elements and QMS requirements)
2. Quality Unit (site) Management
3. Risk Management
4. Training and personnel qualification
5. Change Control and Management (Pre and Post change analysis)
6. Investigations and corrective and preventive action (CAPA)
7. Audits and self-inspections
8. Documents and records management (GMP document system)
9. Product quality complaints vs. adverse event reports
10. Product trend requirements
11. Supplier and contractor quality management
The presenter will share new information and industry best practices and provide ample opportunity to ask questions. Attendees are highly encouraged to submit pre training questions. The instructor will make every effort to cover or answer most of the questions during the presentation or during Q&A the session.
Who will benefit:
This webinar will be beneficial to the following personnel in Pharmaceutical and Biopharmceutical companies that are subject to EU and FDA GMP compliance:
- Quality Assurance
- Production
- Engineering
- Quality control
- Supply chain
- Product development
- Regulatory affairs
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Organized by:
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Complianceonline |
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Invited Speakers:
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Tanvir Mahmud, has more than 15 years experience in product development, quality and project management in regulated industries including Biogen Idec, Vertex Pharmaceuticals, Boston Scientific and Consulting Companies. She has a Masters Degree in Physical and Biochemistry and a Master Certification in coaching. Her professional experience relates to research and development, analytical development, formulation development, quality management, chemistry manufacturing and control, drug/device/biologics/combination product stability, training, leadership development and program management.
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Deadline for Abstracts:
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2013-01-10
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Registration:
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http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702633?channel=hummolgen
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E-mail:
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referral@complianceonline.com
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