About this course
Over the past year or so data integrity has become a ‘hot topic’ for both EU regulatory inspectors and the FDA. Problems with data integrity have been identified at finished product and API manufacturing sites around the globe and have resulted in vigorous regulatory actions such as import bans and recalls. The majority of the recently reported issues with data integrity relate to data generated by QC laboratories; for example modification of HPLC results or simply discarding inconvenient results.
Auditing for data integrity requires a different, more challenging, approach from the auditor. This course is designed to provide you with the necessary skills and understanding to ensure that you can include checking for evidence of data fraud during either specific QC laboratory audits or general GMP audits.
Course outline
What You Will Learn
- What to look for as evidence of potential data integrity problems
- How to check HPLC data for evidence of fraudulent manipulation
- How to try to distinguish between genuine errors and fraudulent activity
- How company culture can influence behavior
Who Should Attend
This course will is essential to anyone who conducts audits of pharmaceutical manufacturers or their suppliers.
Why not bring your problems for discussion?
The course offers an ideal opportunity to speak to an experienced tutor and to delegates who are in similar roles. Our courses are planned to inform you and also to enable you to gain answers to your specific queries via debate, group work sessions and a panel discussion.
Venue
Renaissance Manchester City Centre Hotel, Manchester, UK
Located in one of the most exciting cities in UK, the 4 star Renaissance Manchester Hotel is at the heart of Manchester’s entertainment quarter. The hotel features one of the largest conference venues in the city which also provides wireless internet access.
The hotel offers spacious bedrooms with air conditioning, lounge area, excellent workspace and WIFI access.
Hotel Accommodation
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
Renaissance Manchester City Centre Hotel
Blackfriars Street
Manchester
M3 2EQ
England
Tel: +44 (0) 1618 316 000
Fax: +44 (0) 1618 353 077
www.marriott.co.uk
Hotel Bookings
If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following this link
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
Hotel Bookings
If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following “this link - link to be confirmed shortly”
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for this course is:
An NSF International Company 
