cGMP University - GMP training and Proactive Quality Management | Compliance resolution

  • 402 views
Uploaded on

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 …

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.

More in: Business
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
    Be the first to like this
No Downloads

Views

Total Views
402
On Slideshare
0
From Embeds
0
Number of Embeds
0

Actions

Shares
Downloads
1
Comments
0
Likes
0

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide

Transcript

  • 1. We lead in GMP training.Others follow 1WEBINAR SCHEDULE 2013 FINAL
  • 2. We lead in GMP training.Others follow 2 WEBINARS FOR 2013WEBINAR TIME DATE0001 Principles of Corrective 11:00 AM PST/ 2:00PM EST March 19th 2013Action and PreventiveAction(CAPA)0002 How to Manage the 11:00 AM PST/2:00PM EST January 22nd 2013complaint file0003 Change control 11:00 AM PST/2:00PM EST November 20th 20120004 Design controls for medical 11:00 AM PST/2:00 PM EST May 14th 2013device0005 Laboratory controls for the 11:00 AM PST/2:00 PM EST June 16th 2013Pharmaceutical industry0006 GMP for dietary 11:00 AM PST/2:00 PM EST June 23rd 2013supplements0007 How to write SOPs and 11:00 AM PST/2:00 PM EST July 2nd 2013Work Instructions0008 How to perform Quality Risk 11:00 AM PST/2:00 PM EST August 20th 2013Management (QRM)0009 How to perform Root Cause 11:00 AM PST/2:00 PM EST September 17th 2013Analysis
  • 3. We lead in GMP training.Others follow 3WHAT YOU WILL LEARN
  • 4. We lead in GMP training.Others follow 400001: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 500002: 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 600003: 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 700004: 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 800005: 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 900006: 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 1000007: 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 1100008: 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 1200009: 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 COSTRegister on the webinar tab at: http://www.cgmpuniversity.comCost: $ 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