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Pharma and Biopharma Quality System Refresher Course

 
  December 14, 2012  
     
 
ComplianceOnline, Online Event
2013-01-11


Why Should You Attend:

Quality System Training is mandatory per regulatory agencies, no matter where in the world you want to market your medicinal products including Pharmaceuticals and Biopharmaceuticals. Regulatory agencies are looking into seeing whether companies' Quality Systems are in control during License Renewal Inspections, Cause Inspections, System Based Inspections and Pre-approval (PAI) Inspections. Many companies are getting Warning Letters and or Consent Decree due to violations in Quality Systems requirements.

This session will train you in one of the eight major modules of ASQ cGMP Certification Training Program for Pharma and Biopharma. 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.

Learning Objective:

Attendees will gain a thorough understanding of Pharmaceutical and Biopharmaceutical Quality Systems and the associated requirements.

Areas Covered in the Seminar:

  1. Quality Management System (QMS)
  2. Quality Unit (site) Management
  3. Risk Management
  4. Training and personnel qualification
  5. Change Control and Management


Who Will Benefit:

This training webinar has been designed for the following personnel in Pharmaceutical and Biopharmaceutical Industries:

  • Quality Assurance
  • Production
  • Engineering
  • Quality control
  • Supply chain
  • Product development
  • Regulatory affairs
Pharmaceutical and Biopharmaceutical companies that are subject to EU and FDA GMP compliance will benefit from this training.
 
 
Organized by: Complianceonline
Invited Speakers:

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.

Tanvir also worked as an Adjunct Faculty at Southern New Hampshire University, SNHU and Founder and Principal of Find Your Solution (FYS) Consulting and Training, a company offering training and consulting in Quality Management, employee development and performance improvement. FYS assists companies to achieve results by designing, developing and implementing efficient processes and effective training programs for employee to improve patient outcomes.

Tanvir designs, develops and delivers training in Quality Risk Management, cGMP for ASQ Professional Certification and other customized training for Pharma, Biopharma and Medical Device Industries.

Tanvir is a member of the Regulatory Affairs Professional Society, Boston Trainer’s Roundtable, Boston Facilitator’s Roundtable and Project Management Institute.

 
Deadline for Abstracts: 2013-01-10
 
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702633?channel=Hummolgen
E-mail: referral@complianceonline.com
 
   
 
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