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.
- 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
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.
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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Do you wish to customize this course to suit your needs?
If so, running the course in-house is probably the best and most cost effective solution.
"Fantastic experience from course leader, very interesting."
Intermediate / Advanced
Mr. John Y. Lee
Date, location and venue:
7-8 May 2019, Copenhagen
(Entrance from Kvægtorvsgade)
8.30-16.30 (Registration 08.00-08.30, day 1)
Register by 26 Mar and save 1 500 DKK (€ 200)
Until 26 Okt: 13 780 DKK (€ 1 850)
From 27 Okt: 15 280 DKK (€ 2 050)
incl. course material (pdf), lunch and refreshments
Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together for the same course we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
Quantity disconts can not be combined with other discounts or offers.
We do not offer or practice any general company discounts without commitments and/or written agreements.
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.
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.