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:
- Quality Management System (QMS)
- Quality Unit (site) Management
- Risk Management
- Training and personnel qualification
- 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.