J u n e 1 , 2 0 1 5 – M a r t ı H o t e l , I S TA N B U L

Introduction

This is an intensive one day course covering the requirements for carrying out “Out of Specification” or OOS investigations.

The major guidance that describes OOS is the FDA guidance and this provides a common basis for both US and European companies. The background to the current FDA guidance will be reviewed to demonstrate how regulatory thinking has developed. Recently the MHRA has published an advanced and detailed OOS system which was updated in 2013 and this will be reviewed in depth. It covers an in-depth review of investigations of laboratory OOS and will cover general principles of how to carry out an investigation will be described including both hard and soft skills. Examples of non-compliance issues arising from incorrect Out of Specifications will be discussed in detail. The course will go beyond the laboratory phase and examine issues that can arise in production that can cause OOS.There are certain areas of OOS that require special consideration. These will be reviewed and include Dissolution OOS, Microbiological OOS, OOS in Research and Development and aspects of OOS, OOT and OOE in stability testing.Finally a number of different factors will be reviewed that can be introduced into practice that can reduce the amount of OOS’s created in the laboratory.

Topics will include;

• Introduction to the Investigation of OOS Test Results• Evaluation of OOS Test Results in Quality Control Laboratories• OOS Results – Expectations of a European Guidance• How to Carry out an Investigation• Data integrity – the end of one investigation and the beginning of another• OOS Results in R&D Laboratories• Effective Prevention-Strategies on How to Avoid OOS Results in the Lab.

Why You Should Attend?Out of Specification issues have become a major area of non-compliance since the introduction of the first guidance in 1998. Further guidances have been published in 2006 (FDA) and 2010 (MHRA) have extended the OOS into the manufacturing environment. Apart from being a major issue in compliance audits and inspections many auditors use OOS’s as a prime means of evaluating the efficiency of quality systems in a company and for observing how the OOS leads to appropriate CAPA.

Who Should Attend? Pharma Professionals responsible for investigations, CAPA and Change Control, Quality Control Analysts, Quality Control Record Reviewers, Quality Control Supervisors, Quality Control Managers, Quality Assurance Record Reviewers, Quality Assurance Supervisors, Quality Assurance Managers, Production Supervisors, Professionals working with contract laboratories. r

Out of Specification

P h o n e : + 9 0 ( 2 1 2 ) 2 4 4 7 4 5 4 M o b i l e : + 9 0 ( 5 3 0 ) 1 7 6 9 9 8 6i n f o @ m k i s t a n b u l . c o m w w w. m k i s t a n b u l . c o m

Out of SpecificationJ u n e 1 , 2 0 1 5 – M a r t ı H o t e l , I S TA N B U L

Programme

09:00-10:30 Introduction to the Investigation of OOS Test Results • Barr case as starting point of the OOS regulations • The OOS guidance of 1998 and final guidance 2006 and key issues, differences from 1998 draft • Current issues as evidenced by Warning Letters.

10:30-11:00 Coffee Break 11:00-12:30 Evaluation of OOS Test Results in Quality Control Laboratories • Identification of OOS results • Isolation/invalidation of initial OOS results and number of retests • Initial phase of laboratory investigation and when should you inform QA and Production

12:30-13:30 Lunch

13:30-15:00 OOS Results – Expectations of a European Guidance • The MHRA flow chart • Phase 1,2 & 3 investigations • OOS aberrant and anomalous results and correctable results

How to carry out an Investigation • How to appropriately investigate the OOS problems and how to conduct interviews

15:00-15:30 Coffee Break

15:30-17:00 OOS Results in R&D Laboratories • Effective prevention strategies on how to avoid OOS results in the Lab : Strategies on how to avoid OOS results in the lab and application of Poka Yoke approach to reducing OOS.

Dr. Malcolm Ross is the Managing Director of Generapharm-Consulting specialising in training, project management, formulation and analytical development and QA/GMP in the Pharmaceutical industry. With over 30 years experience in the Pharmaceutical industry, Malcolm has been intimately involved in strategy planning and analysis, pipeline management and related activities. Technically specialized in the development of finished dosage forms from both the analytical andformulation aspects and was responsible for establishing R&D in several generic companies in different international environments. He is an acknowledged expert in pharmaceutical analysis and has had responsibility in areas of QA including worldwide auditing, validation and technology transfer. After establishing Generapharm he has been involved in training and

consultin for a large number ofcompanies, including major companies active in both the generic and innovator space. . Registration Fee : 475 EUR + %18 VAT

Early Registration Fee / Date : 395 EUR + %18 VAT before April 10, 2015Transfers should be made to Turkiye Garanti Bankasi, Cihangir Branch (Branch Code: 575), EUR Account No: 908 82 92(Account holder is MK Danismanlik Egitim Tıbbi Urunler Ltd. Sti.) IBAN No : TR65 0006 2000 5750 0009 0882 92*The seminar will be held in ENGLISH. Registration fee includes course documentation, lunch and mid-session coffee breaks. No refunds will be given in case of a cancellation but change in the name of the delegate will be possible. In the event of circumstances beyond its control, MK Consultancy Training reserves the right to change the date and/or cancel the programme; in this case fees will be refunded.