Compliance Seminars®

GMP Compliance Auditing

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.


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.

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.

Gate2GMP®

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »

 

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Rating and comments:
4.2 of 5
"Fantastic experience from course leader, very interesting."

 

Course facts

Course no:
5201
Industry:
Pharmaceuticals

Level:
Intermediate / Advanced
GMP region:
US

Language:
English
Instructor:

Mr. John Y. Lee

Date, location and venue:

11-12 June 2018, Copenhagen Denmark
DGI-byen
Tietgensgade 65    
(Entrance from Kvægtorvsgade)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Webers (500m)
» Scandic Copenhagen (800m)


Time:
2 days
8.30-16.30 (Registration 08.00-08.30, day 1)

Price (excl. local VAT):
14 400 DKK (€ 1 925) incl. course material (pdf), lunches and refreshments
Note. Accommodation is NOT included in the course fee.

Discounts:
For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
* If you still want a printed course handouts binder from us, we charge 50 Euro/pcs (of which 10 Euro to TRINE for clean energy projects)

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.