"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Pharmaceuticals and Medical Devices
Unique training to become certified Auditor/ Lead Auditor
This tailor-made training gives you the tools and skills required as Auditor or Lead Auditor. The course covers the core elements of ISO19011, Guidelines for Auditing Management systems and includes several practical exercises that will help you apply your knowledge to real-life scenarios.
The training is also designed to serve as preparation if you plan to become certified as Auditor/Lead Auditor Pharmaceutical or Medical Devices.
(Read more about the certification process for Auditor/Lead Auditor at www.sbq.nu)
Audit principles covered in this training are based on the international recognized standard ISO 19011:2011. The content is tailor made for pharmaceutical and medical device organizations with strong focus on what to audit and how to verify compliance in the pharmaceutical and medical device industry. This training will give you the right tools regardless if you are going to audit the internal quality system against e.g. medical device regulations, ISO 13485 or GMP/QS requirements* or if you are going to audit suppliers/contract manufacturers.
* EU GMP Vol 4, 21 CFR210/211, 21 CFR 820
After the course you will be able to perform and lead internal and external GMP/Quality System audits and also act as an escort at audits from contractors or inspections from authorities, notified bodies and certification bodies. You will also be prepared for an individual certification exam as Auditor or Lead Auditor for Pharmaceuticals or Medical Devices (read more about the personal certification at www.sbq.nu)
Who should attend?
QA professionals doing internal or external audits, or persons in the process of becoming auditors who need:
- knowledge about auditing techniques to verify that requirements applicable to the audited organization has been fulfilled.
- documented competency, as auditor in the Life Science industry.
Prerequisites (Previous knowledge)
At least one year professional experience within the pharmaceutical or medical device industry and basic knowledge about regulatory requirements and quality system in the same industry (i.e. GMP, ISO 13485 and/or 21 CFR 820). It is a benefit if you have some experience in auditing. If you have no previous auditing experience and intend to apply for Certification after the course we recommend that you read more about the Certification criteria’s at www.sbq.nu.
- Be capable to plan, perform, report and follow-up on internal and external audits.
- Plan audit programs and perform audits on system and corporation level.
- To select and apply the most suitable audit method for a specific audit scope and objective.
- Understand important aspects on leading an audit team.
- Get introductory information about regulatory requirements on quality system from an auditing perspective.
- As auditor, being able to verify fulfillment or non-fulfillment of the audit criteria.
- Audits - Purpose and objective
- Quality systems from an auditing perspective
- ISO 19011
- Audit planning; Audit program and audit plan. Audit team
- Perform audits
- Preparation – document review and checklists
- Interviewing techniques
- To meet and treat different types of personalities
- Document internal audits
- Roles and responsibilities
- Program Manager
- Lead Auditor/Auditor
- Cultural differences
- Supplier audits
- Audits in complex organizations
- Writing the audit report
- Classification of findings
- Follow-up; Verification of actions and effectiveness
- Audit summary and presentation for management
- Summary – wrap up.
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 »
This course in-house?
Are you a group in need of the same training?
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.
Pharmaceuticals and Medical Devices
Intermediate / Expert
US and EU
Date, location and venue:
23-25 January 2018, Copenhagen
(Entrance from Kvægtorvsgade)
This course is also offered in-house.
Click here for more info and inquiry form.
Day 1: 10.00-appr. 19.30* (Registration 9.30-10.00)
Day 2: 8.00-17.00
Day 3: 8.00-16.00
*Note. Evening session as group workshop. The time can vary.
Supper is not included.
Price (excl. local VAT):
17 900 DKK (€ 2 395) incl. course material (pdf), lunches and refreshments.
Note! If combined with one of the following courses we offer a total price of 32 220 DKK (€4 310):
• Medical device quality management - Key requirements in MDR, QSReg and ISO13485
• Pharmaceutical xxxxxxx - Key requirements in 21CFR210/211 and the EU GMP Guides.
Note. Due to tax/VAT regulations within the EU, the course fee is invoiced in the local currency.
Accommodation is NOT included in the course fee.
Individual certification test Auditor/Lead Auditor for Pharmaceuticals or Medical Devices is performed by SBQ Certification AB.
» More information from SBQ Certification AB
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.
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 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.