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5201 GMP Compliance Auditing
Instructor:
Mr. John Y. Lee »
Next course:
October 19-20 2009, Copenhagen, Denmark
Course Venue:
» IDA Mødecenter, Copenhagen
Agenda:
Day 1: 8.30-16.30 Registration 08.00-08.30
Day 2: 8.30-16.30
Price:
€ 1.795 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
Mr. John Y. Lee »
Next course:
October 19-20 2009, Copenhagen, Denmark
Course Venue:
» IDA Mødecenter, Copenhagen
Agenda:
Day 1: 8.30-16.30 Registration 08.00-08.30
Day 2: 8.30-16.30
Price:
€ 1.795 incl. course material, lunches and refreshments
Discounts:
We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:
Registration is binding. If for any reason a registered participant is unable to attend, substitution is always possible and preferred. All cancellations must be in writing (letter, fax or e-mail). Cancellations received less than 21 calendar days before course start are subjected to a service charge of 200 € + 100 €/course day (Euro). No refunds or credits are issued for failure to cancel or "no show". Courses may be cancelled by the organiser if bookings fail to reach minimum numbers. In such circumstances course fees will be refunded.
Industry field:
Pharmaceutical industry
Course description:
Although quality and compliance auditing is not specifically required by drug GMPs, it has been an integral element of many pharmaceutical operations. The FDA has always expected self-audit programs and has criticized companies for failing to conduct such audits. This course will discuss some of the practical and proven techniques for conducting effective audits of various pharmaceutical operations, to identify the critical deficiencies associated with GMP compliance and product quality.
Course outline:
• Compliance Audit Program
• FDA/GMP Requirements and Audit Focus for Contractors
• Auditor Training and Audit Tools
• General Compliance Auditing
-Raw material control
-Weighing and dispensing
-Manufacturing controls
-Packaging and labeling controls
-Calibration and maintenance programs
-Quality assurance programs
• Auditing Chemical/Biological APIs
• Auditing Validation and Qualification Studies
• Auditing Purified Water Systems
Learning objectives:
Attendees will gain practical knowledge in establishing an effective GMP compliance audit program and auditor training program. They will learn practical skills for conducting GMP compliance audits, and know what to look for when conducting audits of various pharmaceutical operations. They will be familiar with the audit tools that are available to them. Attendees will also have a chance to review and discuss current GMP compliance issues.
Who should attend:
This course is intended for professionals who are responsible for GMP Compliance and Auditing, at both the beginner and advanced levels. Production and Quality professionals will benefit by learning the potential problem areas so that appropriate actions can be taken. Regulatory professionals who are responsible for FDA inspections and contact should also attend.
Pharmaceutical industry
Course description:
Although quality and compliance auditing is not specifically required by drug GMPs, it has been an integral element of many pharmaceutical operations. The FDA has always expected self-audit programs and has criticized companies for failing to conduct such audits. This course will discuss some of the practical and proven techniques for conducting effective audits of various pharmaceutical operations, to identify the critical deficiencies associated with GMP compliance and product quality.
Course outline:
• Compliance Audit Program
• FDA/GMP Requirements and Audit Focus for Contractors
• Auditor Training and Audit Tools
• General Compliance Auditing
-Raw material control
-Weighing and dispensing
-Manufacturing controls
-Packaging and labeling controls
-Calibration and maintenance programs
-Quality assurance programs
• Auditing Chemical/Biological APIs
• Auditing Validation and Qualification Studies
• Auditing Purified Water Systems
Learning objectives:
Attendees will gain practical knowledge in establishing an effective GMP compliance audit program and auditor training program. They will learn practical skills for conducting GMP compliance audits, and know what to look for when conducting audits of various pharmaceutical operations. They will be familiar with the audit tools that are available to them. Attendees will also have a chance to review and discuss current GMP compliance issues.
Who should attend:
This course is intended for professionals who are responsible for GMP Compliance and Auditing, at both the beginner and advanced levels. Production and Quality professionals will benefit by learning the potential problem areas so that appropriate actions can be taken. Regulatory professionals who are responsible for FDA inspections and contact should also attend.
Lundén/Ellow ab and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Phone: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com