events

HUM-MOLGEN -> Events -> Courses and Workshops

Search

GMP Auditor Training (2 day)

January 13, 2012

PharmaTraining Limited, Window Conference Venue, 13 Windsor Street. Islington, London, N1 8QG 14 & 15 May 2012 Day 1 Auditing Basics Reasons for audits and audit models (overview). The Purpose of Audits. Role Characteristics of the Auditor. Audit Types. Audit Classification. Audit Methods. General Themes for All Audits Auditing Tools and Techniques Basic tools. Audit Techniques. Audit Planning DAY 2 The audit process Audit scheduling. Conducting the audit. Managing the Audit Team. The Exit Meeting. Audit Reporting. Audit Closeout Improving the audit system Adding Value from the Audit programme. Corrective and Preventive Action The necessity of structured investigation. How FDA investigate CAPA Added Value from Self Inspections (Level2 ¡V QA Led) A practical Level 2 inspection programme (based on Auditor Training). Purpose of the self inspection programme. Establishing the programme. Setting up and training the inspection team.Conducting the inspection and reporting What to look for when Auditing Products Manufacturers Oral solid and liquid dosage forms. Packaging and labelling. Distribution. QC Laboratories. Computer systems The course will include several Workshops on specific aspects of the programme

Organized by:			PharmaTraining Ltd
Invited Speakers:			DR DAVID INGLIS is a consultant specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. David has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning / decontamination, especially in bulk intermediates and APIs. He has a Ph.D. degree in enzyme chemistry (affinity chromatography). During more than 29 years in Quality Assurance in the pharmaceutical industry, Dr Inglis has gained extensive experience of Quality Management, through roles in QA laboratories, GMP compliance and regulatory compliance. He successfully pioneered automated HPLC methods, then managed all aspects of QC laboratories before spending the following 11 years managing and developing Quality Assurance, including documentation, control of change, auditing and routine regulatory compliance to cGMP. He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates for use in clinical trials. David is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for FDA/MHRA inspections, including FDA “Systems” based inspections. He has extensive experience of being the lead spokesman during major regulatory audits. Dr Inglis is a specialist in cGMP training and QA system improvement. His flagship improve-ment package details a system of secure GMP compliance at competitive cost. For conceiving and developing this package, Dr Inglis received the highest level of recognition for excellence from a global pharmaceutical manufacturing company.

Deadline for Abstracts:			N/A

Registration:			REGISTRATION FORM GMP Auditor Training, 14 & 15 May 2012 – London Early-bird fee: 2 day course £1062.00 (+ VAT £212.40 if applicable, see notes on VAT) If booked and paid by early-bird date 16 March 2012 GMP Auditor Training, 14 & 15 May 2012 – London Full Fee:2 day course £1180.00 (+VAT £236.00 if applicable, see notes on VAT) How to Audit API Manufacturers, 16 May 2012 - London Early-bird fee: 1 day course £549.00 (+ VAT £109.80 if applicable, see notes on VAT) If booked and paid by early-bird date 21 March 2012 How to Audit API Manufacturers, 16 May 2012 - London Full Fee:1 day course £610.00 (+VAT £122.00 if applicable, see notes on VAT) Discounted rate of 10% for booking 8 weeks in advance Discounted rate of 10% for booking more than 1 delegate Discounted rate of 10% for booking more than 1 course Maximum discount received is 15% VAT NOTES: UK: Under UK law all UK-based applications are subject to VAT at the prevailing rate however most UK VAT registered compa-nies/organisations can reclaim this tax. EU: With effect from 1 January 2011 applications from delegates whose companies are based in EU countries will not be subject to VAT PROVIDED THAT valid VAT ID details are provided at the time of booking, otherwise VAT will be charged. VAT ID No.______________________ OTHER: With effect from 1 January 2011 applications from delegates whose companies are based outside of the UK/EU will be outside the scope of VAT, ie no VAT is charged or payable. Title (Mr/Mrs/Ms/Dr/Prof): First Name: Surname: Job Title: Company: Address: Post Code: Country: Tel: Fax: Email address: Signature: Method of Payment: □ Cheque (Please make payable to “PharmaTraining Ltd”) □ Bank transfer □ Credit/Debit Card ( please register online) Online Registration is available on our website: www.pharma-training-courses.com Data Protection PharmaTraining Ltd gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other products and services. If you have any queries or want to update any of the data that we hold then please contact us. PharmaTraining BioCity Nottingham Pennyfoot Street Nottingham NG1 1GF UK Tel: 0044 (0)115 9124249 Fax:0044 (0)20 7681 3582 info@pharma-training-courses.com
E-mail:			judy@pharma-training-courses.com

events

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.