How to Audit Chemical API Manufacture

About this course

Auditing of API manufacturers is receiving increasing scrutiny from European regulators primarily as a result of recent issues around counterfeiting of medicines such as the well-known Heparin scandal. In the European Union the responsibility for GMP conformity for the medicinal product lies with the Qualified Person of the holder of the marketing authorisation, and this includes GMP at the site of API manufacture.

From January 2013 the situation has become even more onerous for the MAA holder as the Qualified Person has to declare that they are satisfied with GMP controls within the whole of the supply chain, which includes the supply chain of the API manufacturer(s) used by that MAA holder.

European Union inspection bodies are placing even more scrutiny on the audits carried out for your companies to allow this declaration around the supply chain.

During this course we will discuss the standards used and the industry norms applied during the audit of API manufacturers. The aim of the course is to:

• Improve your knowledge in the area of API auditing
• Improve your skills in preparing for API audits
• Increase confidence in conducting API audits
• Understand how to report observations and respond to corrective action plans

We will also develop the tools you will need such as an audit plan and aide-mémoires to cover specific areas within that audit.

If you are interested in this course you might also want to check the following :

Active Pharmaceutical Ingredients. 15 to 18 June, Newcastle, UK

Course outline

New directives and expectations place increasing pressures on companies to audit the entire supply chain of starting materials including excipients.

We will be running this highly interactive course with the following objectives:

• Remind auditors of the key legislation and guidance around auditing excipients, GMP, IPEC, ISO 9000
• What is the role of EXCiPACT™?
• How to construct an audit plan or agenda that works
• Working through case studies and audit observations to discuss the severity ranking and references to support findings
• What to do when time on site is limited, shared or impossible

As with all ‘How to Audit’ courses there will be plenty of opportunity for questions and answers as well as sharing best practice with fellow auditors.

Spaces are limited on the ‘How to Audit’ courses to maintain the interactivity and to ensure your questions are answered, so early booking is recommended.

Venue

Newcastle Marriott Gosforth Park, Newcastle, UK

Set on 12 acres of parkland near Newcastle City Center and Newcastle International Airport, the Newcastle Marriott Hotel Gosforth Park offers the ideal setting.

The Newcastle hotel’s beautifully renovated guest rooms have high-speed internet access. The Hotel also has an impressive range of leisure facilities includeding a well-equipped gym, tennis courts, pool, sauna and squash courts. You can also pamper yourself at the spa located inside the hotel.

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 will be provided to you on receipt of a completed booking form.
• 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

Newcastle Marriott Gosforth Park
High Gosforth Park
Newcastle upon Tyne, NE3 5HN
England

Tel: +44 (0) 191 236 4111
Fax: +44 (0) 191 236 8192

www.marriott.com

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.

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 experts for this course are:

• 

  Mrs Susan Rocca
  Consultant
  BSc (Hons)

  • [email protected]
  • +44(0)1751 432999

What you've said

“Good practical advice from an experienced tutor.” Nick Medcalf, Smith & Nephew, UK