Advanced GDP & GMPCourse

Learning ObjectivesUnderstad the pharmaceuticalsupply chain system GDPcompliance requirements

Manage critical documentationto cover the whole supply chain

Learn how to evaluate and assess the risks

Mitigate risks of pharmaceuticalproducts in the global supply chain

Comply with cool chainmanagement guidelines

Please note that the number of places is stricly limited

Suite 2, 34a Dzirnavu Street, Riga, Latvia trainings@inpharmatis.com www.inpharmatis.com+371 67 210 500

October 4-5, 2018Riga, Latvia

Get a full understanding of current regulatory frame in GMP

Gain a complete picture of today’s hot topics about GMP complience

Review key aspects related to buildings, equipment, utilities, personnel, materials, operations

Meet the requirements of quality systems & metrics

Know the specifics and details of supply chain management

Understand the responsibilities of the Qualified Person (QP)

See the value of risk management & incidence management

Prepare for quality continuous monitoring and improvement

Advanced GDP & GMP CourseTwo-day Training Course

In Latvia alone there have been at least three GDP License revocations over the last year, with several licenses under review, similar situation is in Lithuania and Estonia.

Are you compliant?Advanced Good Distribution Practices and Good Manufacturing Practices Course presented by the world’s most respected experts in GDP auditing, strategy, compliance & preparation for serialisation. This intensive, packed with practical and interactive exercises two-day course is designed for professionals with at least two years experience in drug supply chain management. The course was developed following extensive research and consultation with the industry professionals in the Baltic area and will provide a comprehensive, yet practical assessment of regulations required for compliance during inspections.

For more details or initial consultation, please contact our Training Specialists Team

Performance & Design of the Course Who Should Attend?This course will be beneficial to:

Responsible specialists

Qualified Persons (QP)

Industrial pharmacists

Production plant managers

Supply chain managers

Active substance unit managers

Start- ups in pharma manufacturing

Business development managers

Auditors

All kind of managers involved in pharma

manufacturing

course is designed according the “flipped learning (FL)” concept

This to

is instructional and type of blended learningclassroom & moving activities into the classroom

FL an strategyby delivering instructional content outside the of

In FL attendees engage concepts in the classroom withexperience between attendees

inthe guidance of mentor, sharing knowledge and a

This training is providing double benefit per one part the attendees receive direct training from the expert (mentor) and the discussions in groups provide better understanding and knowledge sharing

a as

Classroom activities will organized groups. Group discussions are guided by answering key questions carefully predefined for each of session

in

Full introduction the topics the will center the focus of the course

of by mentor

Your Distinguished Trainer: Bernard LawlorIn his role as Responsible Person in RPCS Bernard assists interested parties in implementing the new GDP Guidelines 2013/C 343/01 into their existing Quality Management Systems. He provides contracted GDP support in all relevant areas, e.g., self inspections, training (face to face and on line), QMS review, HPRA audit preparation and deficiency close out, technical and administrative variations, applications for new Wholesale Distribution Authorizations (WDA), gap analysis versus new GDP guides, helping Management understand their new roles and responsibilities in terms of risk but above all, Bernard offerspractical and common sense support and advice to hard pressed RPs and DRPs.

Advanced GDP & GMP CourseTwo-day Training Course Agenda

DAY ONE

Introduction to Pharmaceutical Logistics & GDPInteractive Exercise: Terminology and abbreviations History of GDP through the eyes of the stakeholders Understand key challenges the logistics industry faces with regards to GDP CCP (Critical Control Points): How to identify and use risk based assessment to mitigate risk

Interactive Exercise: Identification of CCPs duringthe supply chain Reality of current supply chains. What’s really happening and how products are really handled

Global GDP Regulations Recognise the regulatory bodies and respective guidelines globally for GDP for Medicinal Products for Human use Good Distribution Practice: How do we manage the supply chain globally and remain compliant to all regulations Global GDP regulatory expectations from Health Authorities and stakeholders WHO, US Pharmacopeia 1079, EU GDP Guidelines, Chapter 17 IATA, Differences and anomalies

Why Packaging matters? Temperature Controlled packaging (TCP) Current products Best application of product to product how to choose and what factors to consider Operational management considerations for different product types Collaboration of stakeholders in designing TCP suitability

Freight solution evaluation Risk based SOP design Security and lane validation audits Collaboration of key stakeholders to develop robust compliant SOP’S or LOP’S How to create a compliant supply chain and the process involved such as SOPs & SLAs Interactive Exercise: SOP development

EU GDP Guidelines for medicinal products for human use Develop a quality management approach to all areas within the distribution of Medicinal. Products for Human Use Chapter 1 – Quality Management System Chapter 2 – Personnel Chapter 3 – Premises and Equipment Chapter 4 – Documentation Chapter 5 – Operations

DAY TWO

EU GDP Guidelines for medicinal products for human use (continued) Develop a quality management approach to all areas within the distribution of Medicinal Products for Human Use Chapter 6 – Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls Chapter 7 – Outsourced Activities Chapter 8 – Self-inspection Chapter 9 – Transportation Chapter 10 – Specific Provisions for Brokers

Interactive Exercise: GDP in the supply chain andyour roles & responsibilities

Regulatory frameCurrent regulatory frame and responsibilitiesEvolution of the sector during the last yearsNew view on GMP compliance. ICH Q8, Q9, Q10, Q11

Quality Oversight

Hot topics in today’s GMPQuality MetricsSupply ChainData IntegrityException management: Investigation, root cause

Workgroup session 1 Facilities and manufacturing operationsBuilding, facilities, equipment and servicesPersonnel and materials flowManufacturing operations

Workgroup session 2 Quality system and improvementRisk ManagementTechnology transferValidationException Management and CAPAQuality monitoring and continious improving Counterfait avoidance strategy ased on serilialisation, aggregation

and inviolability Computer systems and technology; a key element of the counterfait

avoidance

Workgroup session 3 Supply chain Supplier qualification (excipients, api, packaging, transport)

Advanced GDP & GMPCourseDates: 4– 5 October 2018Venue: Inpharmatis Riga Headquarters

5 EASY WAYS TO REGISTER

+371 67 210 500+371 67 210 501trainings@inpharmatis.comwww.inpharmatis.comInpharmatis SIASuite 2, 34a Dzirnavu StreetRiga, LV-1010, Latvia

CANCELLATIONS: Confirm your cancellations in writing 3 weeks before the date and receive a 50% refund. Customer may reschedule a booking to another date at a 100% rescheduling fee by advising Inpharmatis of such rescheduling in writing

Tick Date Course Full price VAT Total PriceI would like to participate for:

4-5.10.2018 Advanced GDP&GMP 1495.00 Euro 21% 1808.95 Euro

First Name Company NameLast Name Company AddressJob TitleMobile No. Tel. numberEmail Billing address (if different)Any special requirements Reg. number VAT number

I qualify for 100 Euro corporate discount for booking more than one participant per courseI qualify for 100 Euro early bird discount by booking 6 weeks before the course

I would like to receive information about future events and services

Information about participant:

Tick the topics that might be of your interest

Advanced EU Regulatory Affairs Pharmacovigilance StrategyAdvanced GDP & Serialisation Strategy in Drug Regulatory AffairsIntroduction to RA in EU Intermediate Sales skills in PharmaFiling Variations in EU Advanced Sales skills in PharmaeSubmissions Food SupplementsGDP Pharmalead Nova – mini MBA for pharma executivesGMP In-house trainingParallel Import Other…

I hereby declare that I agree to the terms and conditions and that information supplied by me is correct

Interest Form

Suite 2, 34a Dzirnavu Street, Riga, Latvia trainings@inpharmatis.com www.inpharmatis.com+371 67 210 500