cGMP University - GMP training and Proactive Quality Management | Compliance resolution
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cGMP University - GMP/CGMP (Good Manufacturing Practice) information, regulations and literature for pharmaceutical industry. cgmp provides state of the art GMP know how that gives guidance in your business.
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cGMP University - GMP training and Proactive Quality Management | Compliance resolution
- 1. We lead in GMP training.Others follow 1 WEBINAR SCHEDULE 2013 FINAL
- 2. We lead in GMP training.Others follow 2 WEBINARS FOR 2013 WEBINAR TIME DATE 0001 Principles of Corrective 11:00 AM PST/ 2:00PM EST March 19th 2013 Action and Preventive Action(CAPA) 0002 How to Manage the 11:00 AM PST/2:00PM EST January 22nd 2013 complaint file 0003 Change control 11:00 AM PST/2:00PM EST November 20th 2012 0004 Design controls for medical 11:00 AM PST/2:00 PM EST May 14th 2013 device 0005 Laboratory controls for the 11:00 AM PST/2:00 PM EST June 16th 2013 Pharmaceutical industry 0006 GMP for dietary 11:00 AM PST/2:00 PM EST June 23rd 2013 supplements 0007 How to write SOPs and 11:00 AM PST/2:00 PM EST July 2nd 2013 Work Instructions 0008 How to perform Quality Risk 11:00 AM PST/2:00 PM EST August 20th 2013 Management (QRM) 0009 How to perform Root Cause 11:00 AM PST/2:00 PM EST September 17th 2013 Analysis
- 3. We lead in GMP training.Others follow 3 WHAT YOU WILL LEARN
- 4. We lead in GMP training.Others follow 4 00001:Principles of Corrective Action and Preventive Action (CAPA) What you will learn: • CAPA life cycle: From discovery to CAPA closure • QSR requirements for a CAPA system • How to initiate Corrective Action and preventive Action • How to Prioritize nonconformities using QRM • Root-cause Analysis tools Who will benefit? • Quality Engineers • Nonconformance investigators • Manufacturing Engineers • Quality Managers
- 5. We lead in GMP training.Others follow 5 00002: How to manage the complaint system What you will learn: • Regulatory requirements for the complaint system • Using Quality Risk Assessment to prioritize complaints • How to initiate complaint investigation • How to manage the complaint system • Complaint system metrics Who will benefit? • Quality Engineers • Complaint investigators • Complaint system managers • Quality Managers
- 6. We lead in GMP training. Others follow 6 00003: Change control What you will learn: • Regulatory requirements for change control • The Change control life cycle • How to perform risk assessment • How to perform impact assessment • Performance matrix for a change control system Who will benefit? • Validation Engineers • Change control managers • Quality system managers • Supplier Quality professional
- 7. We lead in GMP training. Others follow 7 00004: Design controls for medical device What you will learn: • Regulatory requirements for design controls • The device design life cycle • Contents of the Design History File (DHF) • Product design models for medical device • Design change control and design validation Who will benefit? • Product design Engineers • Project managers • Quality system managers • Quality Engineers
- 8. We lead in GMP training. Others follow 8 00005: Laboratory controls for the Pharmaceutical industry What you will learn: • Regulatory requirements for laboratory controls • Good Laboratory Practices, GLP. • How to investigate OOS results • Laboratory equipment management Who will benefit? • Contract laboratory personnel • Laboratory managers • Laboratory technicians • Quality personnel
- 9. We lead in GMP training. Others follow 9 00006: GMP for dietary supplements What you will learn: • Regulatory requirements for supplements • Production and process controls. • Labeling and advertising requirements • Quality control for supplements • Record keeping for dietary supplements Who will benefit? • Manufacturing personnel • Marketing managers • Regulatory personnel • Quality personnel
- 10. We lead in GMP training. Others follow 10 00007: How to write SOPs and Work Instructions. What you will learn: • Document hierarchy in the Quality system • How to write a Quality manual. • How to write a Quality policy • How to write a standard operating procedure, SOP • How to write Work Instructions Who will benefit? • Quality professional • Manufacturing Engineers • Process Engineers • Personnel in startup companies
- 11. We lead in GMP training. Others follow 11 00008: How to Perform Quality Risk Management,(QRM) What you will learn: • ICHQ9 Regulatory requirements for supplements • Production and process controls. • Labeling and advertising requirements • Quality control for supplements • Record keeping for dietary supplements Who will benefit? • Manufacturing personnel • Marketing managers • Regulatory personnel • Quality personnel
- 12. We lead in GMP training. Others follow 12 00009: How to Perform Root-cause Analysis, (RCA) What you will learn: • Root cause Analysis methods • Root Cause Analysis tools • How to choose the right tool for the right job • How to categorize problems and potential problems • Contents of an investigation record Who will benefit? • Nonconformance investigators • CAPA investigators • Manufacturing Engineers • Quality Engineers
- 13. We lead in GMP training.Others follow 13 REGISTRATION AND COST Register on the webinar tab at: http://www.cgmpuniversity.com Cost: $ 245.00 Per 1hour webinar. Register today! Demand for our webinars is usually high. APPROVED By DAVID MUCHEMU at 10:56 pm, 10/10/12