T H E P R O P O S A L F O R T H E Y E A R

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1 Training T H E P R O P O S A L F O R T H E Y E A R Our GMP courses combine a convenient format with an effective, interactive learning experience. To maximize and customize your professional development. W W W. C T P S Y S T E M. C O M

2 Compliance with GMPs is widely accepted as the best way to conduct business, focusing on product quality. Internal training is today a factor of fundamental importance for the development of human resources. The constant care of training subjects produces an added value, visible in every production phase, in terms of: - operating time reduction - coordination improvement - attention to quality. For all these elements, specific staff training is required.

3 Training Proposal F O R E V E R Y L E A R N I N G N E E D S BASIC TRAINING Basic courses on consolidated topics, the result of thirty years of GMP experience in the field, for operators in the Pharmaceutical, Chemical and Healthcare Industry. GXP TRAINING In-depth courses on the innovations of the pharmaceutical sector, with attention to training and regulatory updates, aimed at operators in the Pharmaceutical, Chemical and Health Industry. ADVANCED TRAINING Advanced level courses for those who need to complete and deepen a training path on specific topics. We provide participants with advanced skills and competence tools. BASIC TRAINING ONLINE Basic interactive courses for a dynamic education, with a dedicated software that allows direct connection with the teacher, thus optimizing learning space and time. Complete each of the individual CTP SYSTEM online courses for an overview of all Systems! TRAINING ON DEMAND Our TRAINING ON DEMAND, characterized by extreme flexibility, is created to reconcile the need for continuous business update with urgency imposed by work deadlines. Upon customer request, each Training program can be planned according to the needs of different times and locations, at customer s headquarters or, alternatively, at the CTP SYSTEM offices in Poggibonsi and Milan (also in multi-company format). Training programs are divided into six areas: GMP, ENGINEERING, PROCESS & QUALITY, IT COMPLIANCE, QC LABS and QUALIFICATION & VALIDATION. Each area corresponds to specific modules packages expressly studied by CTP SYSTEM experts, in order to complete in a comprehensive way the training of the company staff operating in compliance with GMPs. GMP AREA courses are planned to perform GMP Refresh for the companies, and to respond to the following regulatory requirement: TRAINING must be established and carried out regularly, or to avoid deviations such as: At the beginning of this INSPECTION, only 14 of 71 operators had been subject to regular training. In addition, training received was inadequate. The OTHER AREAS have courses on specialized topics and GxP interest. Thanks to these courses are conveyed the thirty years of experience of CTP SYSTEM, also taking into account specific needs expressed by Customers. For information about the list of courses, please check our website: where you can ask for more details, also indicating the desired time for programming the courses.

4 Basic Training C O N T I N U O U S L E A R N I N G A P P R O A C H GOOD DISTRIBUTION PRACTICE Regulatory Framework - GDP Guideline International Standards More frequent inspection reliefs PDA Technical Report 39 Guidance for temperature-controlled medicinal products PDA Technical Report TR52-TR53 ASEPTICAL PROCESSES: STERILITY ASSURANCE Controlled contamination environments Hygiene and behavior rules in Clean Room: optimization of flows and materials Steam and terminal sterilization How to validate the aseptic process ANNEX15: NEWS ON QUALIFICATION AND VALIDATION PROCESS The new version of Annex 15: motivations for a deep review and main innovations Qualification of Plants and Equipment: the acquisition of the concepts of integrated C&Q approach and "verification" proposed by the ASTM 2500 standard Process Validation: from traditional approach to Continuous Process Verification Cleaning Validation in the new version of the Annex15: news and confirmations The other aspects of validation: Change Control, Packaging, Transportation QUALITY ENGINEERING: PHARMACEUTICAL DESIGN GEP and quality by design Design Review and not only Design Qualification Engineering aspects according to GEP and GMP Practical management of Commissioning Tests The Quality Engineer inside the Project CLEANING VALIDATION: REGULATORY UPDATE Cleaning procedures Cleaning Validation: regulatory approach Acceptance criteria Worst cases Change control, monitoring and revalidation QUALITY RISK MANAGEMENT Risk Analysis in the pharmaceutical industry and methodologies Application of Risk Analysis to laboratory activities Process validation documents Application of Risk Analysis to the process: definition of critical process parameters Workshop: Risk Analysis applied to a production process - construction of the FMEA table

5 Advanced Training S P E C I F I C L E A R N I N G A P P R O A C H ROOT CAUSE ANALYSIS Correct handling of deviations Impact of Root Cause Analysis Investigations DATA INTEGRITY Human Error Management and Data Integrity The MHRA, WHO, FDA, ISPE Guidelines: news and continuity Data lifecycle management Electronic records management: case studies Electronic data management for automation systems AUDIT GMP: CONDUCTING & REPORTING Audit: introduction and approach Preparation and management of internal documentation before, during and after an inspection General overview: example of conduction Case Study: Audits and Software Suppliers Case Study: Out-Sourcing Audits Case Study: QC Laboratory Audits GMP REFRESH: RULES AND BEHAVIOURS Cleaning procedures Cleaning Validation: regulatory approach Acceptance criteria Worst cases Change control, monitoring and revalidation ISO ACCORDING TO THE REVIEW OF PART 1 AND PART 2. IMPACT ON GMP The relationship between ISO and GMP New features introduced by the review of part 1 and part 2 of ISO 1464 How to build a clean room according to ISO and applicable guidelines Practical examples in the management of a clean room according to the ISO THE GMP FOR THE PRODUCTION OF MEDICINAL GASES GMP Responsibility GMP requirements for document and record management Management and registration of noncompliance and corrective actions GMP terminology and correlation with company definitions Correlation between plant/company documents and GMP requirements

6 Basic Training Online L E A R N I N G A N Y W H E R E NON-STERILE PRODUCTION STERILE PRODUCTION PACKAGING WAREHOUSE MAINTENANCE QUALITY CONTROL INTRODUCTION TO GMP GMP BASIC TRAINING

7 On Demand Training GMP Area GMP01 INTRODUCTION TO GMP, VALIDATION, SUPPORT SYSTEMS GMP: definitions, regulations, goals, Training, Documentation, Change Control and CAPA Maintenance Metrology Validation: definition, development and management, steps, documentation Relationship between engineering and validation (URS, commissioning, from DQ to PQ) GMP02 GMP FOR SUPPLY CHAIN Regulatory framework: from GMP to GSP and GDP Computerization of warehouse and supply chain GSP - Good Storage Practices GDP - Good Distribution Practices Supplier Management GMP03 GMP IMPLEMENTATION IN AN OSD DEPARTMENT GMP manufacturing Hygiene and conduct standards in OSD manufacturing area Environment and personnel protection in OSD manufacturing departments Change and deviation management Non-conformities related to inspection of oral products manufacturing GMP04 GMP IMPLEMENTATION IN CLEAN ROOM GMP manufacturing Hygiene and conduct standards in sterile area Product protection Change Control and deviation management (including CAPA, complaints and Quality Risk Management) Non-conformities related to inspection of sterile products management GMP05 ICHQ9A / ANNEX 20 (EU GMP): RISK ANALYSIS IN PHARMACEUTICAL INDUSTRY Risk Analysis methodology Case Study: Process Risk Analysis. Critical process parameters definition Case Study: FMEA technique for definition of validation tests and metrology program Case Study: The CAPA (Corrective and Preventive Action) program: approach and regulatory references Case Study: Risk Analysis applied to software systems GMP06 - NEW! GMP COACHING AND TRAINING ON QP FUNCTION The QP under Italian and European legislation Different inspection authorities, Italian and European (AIFA, EMA, EDQM, etc.) Professional tasks, duties and responsibilities of a QP Which documents must be signed by a QP? GMP07 - NEW! GMP FOR THE PRODUCTION OF MEDICINAL GASES Insights on GMP requests for the Quality System: roles and responsibilities of the main GMP functions Insights on GMP requests for the Quality System: management of the Quality System for the workshops of production of medicinal gases - deviations and complaints and management of changes (overview) Insights on GMP requests for the Quality System: management of the Quality System for medicinal gas production workshops - internal and external audits, supplier qualification Insights on the production and analytical aspects of medicinal gases Insights on the validation aspects of medicinal gas plants

8 On Demand Training Engineering Area ING01 MAINTENANCE AND ITS ASPECTS The maintenance problem Maintenance documentation Maintainability-oriented design Predictive maintenance issues: use of thermography ING02 HVAC E LAYOUT: HOW TO DESIGN AND QUALIFY A CLEANROOM Controlled contamination environments: applicable regulations and standards Annex 1 and ISO14644 Design of the conditioning system: needs, constraints, problems, solutions Airlock and Changing Room - Generalities and Class Skips Prevention of Cross Contamination in Sampling and Dispensing Areas Pharmaceutical Product Protection against Contamination: Isolators, RABS Validation of controlled contamination environments: the theoretical approach Case Study: the sterile department ING04 GEP: QUALITY DESIGN GEP and quality design for a good activity of commissioning/qualification DQ and Project Review, phases for the engineering costs optimization Engineering issues in compliance with GMP and GEP regulations Qualification of Plants and Equipment: the acquisition of the concepts of integrated C&Q approach and of "verification" proposed by the ASTM 2500 standard ING05 HVAC - FOR ORAL SOLIDS DEPARTMENT References: WHO, ISPE The Cross Contamination problem HVAC and Layout: Examples of Design Airlocks and Lockers: Generalities Conditioning Systems: types, materials and practical examples ING03 THE LIFE CYCLE IN DESIGN, INSTALLATION AND QUALIFICATION OF CRITICAL UTILITIES FOR THE PHARMACEUTICAL WORLD Waters in the pharmaceutical industry: the regulatory framework Systems of water production and distribution: engineering aspects and critical parameters Issues related to microbiological growth within the systems of water production and distribution Steam for pharmaceutical use: tests on steam quality Process gases ING06 AGEING FACILITIES & SYSTEMS: HOW TO FACE THE NEEDS OF AN ADJUSTMENT OF STRUCTURES, EQUIPMENT AND CONTROL SYSTEMS The state of equipment and systems from layout to qualifications: a path between regulations, guidelines and future challenges Control and process monitoring: monitoring and verification process with past systems Data Integrity: a challenge for the future of old systems too Adaptation of environmental monitoring systems to the most recent regulatory and technological guidelines

9 On Demand Training Process & Quality Area PHARMACEUTICAL PRODUCTION PR&Q01 CRITICAL ISSUES OF SUPPLY CHAIN: THE COLD CHAIN Regulatory Introduction ISPE s Good Practice Guide - Cold Chain Management Stability Studies in support of Cold Chain Management Process Mapping, Risk Analysis and activities of Cold Chain Validation Monitoring and validation of environmental parameters in a fixed system Cold Chain: some typical problems PR&Q02 STATISTICAL APPLICATIONS IN MANUFACTURING & QUALITY UNIT Univariate statistical methods in Manufacturing and Quality Control Introduction to non-parametric methods Regression and correlation analysis Statistical Process Control (SPC) Introduction to multivariate statistical techniques Introduction to experimental draw techniques The point of view of inspection authorities PR&Q03 ORAL SOLIDS: TECHNOLOGY & GMP (TECHNOLOGIES AND PROBLEMS) Issues and Problems of Formulation and Preformulation for Oral Solids Powders for Pharmaceutical Use in Oral Solids Formulations OSD Handling: from Dispensing to Blending Granulation: technological characteristics and problems Tablets and Coating Modified Release Formulations IPCs and Analytical Controls PR&Q04 MANUFACTURING AND ANALYTICAL CONTROL IN OUTSOURCING, FROM SERVICE TO PARTNERSHIP Target partnership: how to grow together Technical & Quality Agreement: GMP and legal aspects How to manage a Technological Transfer Supplier Qualification and Risk Analysis: assessment on suppliers of active ingredients, excipients and packaging materials Case Study Analytical & microbiological laboratories: the quality of data PR&Q05 DRUG MANUFACTURING IN ASEPSIS: ASEPTIC TECHNIQUES, CLEAN ROOMS, MEDIA-FILL, CONTROLS Annex 1: scope and impact on manufacturing departments Samplings and Sampling Plan: identification of critical points according to requirements of Annex 1 and FDA Guidance Media-Fill: examples of applications on different types of sterile products Monitoring of bioburden and other factors related to sterilization process Main non-conformities detected by inspection on sterile products manufacturing PR&Q06 RISK ANALYSIS Risk Analysis and methods Risk Assessment as application tool for identifying qualification activities Risk Analysis application to process control/management Risk Analysis application to process: definition of process critical parameters Risk Analysis application to Laboratory activities PR&Q07 QUALITY ASSURANCE ASPECTS Risk Analysis and methods Case Study: Risk Analysis application to process. Definition of process critical parameters Case Study: FMEA technique for definition of validation tests and metrological program Case Study: The CAPA program (Corrective and Preventive Action): the approach and the normative references Case Study: Risk Analysis applied to software systems PR&Q08 GMP FOR PHARMACEUTICAL EXCIPIENTS Excipient GMP Trends: where are we in Europe? Qualification of Excipients for Pharmaceutical Use Change Management Analytical aspects of Excipients PR&Q09 ROOT CAUSE ANALYSIS Correct deviations management Impact of Root Cause Analysis Investigations

10 On Demand Training Process & Quality Area AUDITING PR&Q10 SUPPLIER QUALIFICATION: AUDITS ORGANIZATION AND CONDUCTION EU and non-eu regulatory framework Supplier qualification and audits: how to plan inspections through the risk analysis Audits management and conduction Audits and suppliers typologies Corrective and preventive actions management Aspects reported during audits to suppliers PR&Q11 INSPECTION AUDITS PREPARATION Overview: the typical Audit conduction Preparation and management of internal documentation before, during and after an inspection Overview: example of conduction Internal Audits Inspection Authorities Audits: the Inspector s point of view; the personnel behavior REGULATORY AFFAIRS PR&Q12 REGULATORY AFFAIRS FOR NON- REGULATORY. NON ESSENTIAL CHANGES Minor variations and non essential changes: overview and perspectives ICH Q8 - ICH Q9 - ICH Q10 Guidelines in-depth The Qualified Person: role and responsibilities defined by the current regulation (law decree 219/06 Annex 16) Review of the Variations Regulations Case Study: Batch size change - impact, change management, changes and variations CLEANING VALIDATION PR&Q13 THE DRUGS REGISTRATION DOSSIERS: UPDATE, NEW FORMATS, NEW APPLICATIONS Update on CTD and variations, regulatory trends and harmonization requirements: application of REGULATION (EC) No 1234/2008 Guidelines on the Details of the Various Categories of Variations Preparation of regulatory documentation for European registrations Approach to suppliers regulation and qualification in the new emerging markets Import of drugs, active ingredients and excipients in the European Community: normative, analytical and regulatory issues The shortage of simple, raw and reactive materials in the global market New analytical technologies in the QC field: remarks and regulatory impact PR&Q14 CLEANING VALIDATION Regulatory framework Cleaning procedures, use of detergents/sanitizers Worst Cases Acceptance criteria Recovery Factor Overview of analytical methods

11 On Demand Training IT Compliance Area IT01 COMPLIANCE OF COMPUTER SYSTEMS FOR PLANT MANAGEMENT The starting point: ER, ES and part11 Guidelines MHRA, WHO, FDA, PICS, GAMP Validation Methodology: GAMP 5 Operation phase of the system System configuration Risk Management Typical Architectures of IT Systems GAMP GPG: a risk-based approach to GxP Process Control Systems Data Integrity IT03 DATA INTEGRITY Human Error Management and Data Integrity The MHRA, WHO, FDA, ISPE guidelines. News and continuity Data lifecycle management Management of electronic records. Example case studies Electronic data management for automation systems IT02 COMPUTER SYSTEMS The starting point: the goal to reach Regulation analysis: the aim becomes law Validation Methodology (part one) Validation Methodology (part two) Management of system s life cycle (Operation Phase) Infrastructure qualification QC LABS Area QCLAB01 THE GMP LABORATORY General issues Laboratory equipment qualification Case Study - Microbiological out-of-specification Rapid Microbiology LAL Test Sterility Test QCLAB02 QUALITY ASSURANCE ISSUES Regulatory issues Microbiological sampling in low contamination areas. Criteria for choice of methods and instruments Validation Plan and monitoring of controlled contamination rooms Management of alert/action level ranges and adverse trends in Environmental Microbiological Monitoring Microbiological validation of a UV Pass-box Validation Plan: Selection, Use and Qualification of disinfectants Microbial Identification in support of Environmental Monitoring Plan QCLAB03 STATISTICAL APPLICATIONS IN MANUFACTURING AND QUALITY UNIT Univariate statistical methods in Manufacturing and Quality Control Introduction to non-parametric methods Introduction to experimental draw technique Statistical Process Control (SPC) Introduction to multivariate statistical techniques The point of view of inspection authorities QCLAB04 EXTRACTABLES & LEACHABLES Regulatory References Main plastic materials used in the Industry Sources of contamination Analytical Techniques Strategy for the E&L assessment

12 On Demand Training Qualification & Validation Area CONV01 DRUG MANUFACTURING IN ASEPSIS: ASEPTIC TECHNIQUES, CLEAN ROOMS, MEDIA-FILL, CONTROLS, VALIDATIONS Aseptic manufacturing: the regulatory framework Controlled contamination environments for sterile manufacturing: GMP aspects, validation, monitoring Isotechnics and RABS systems: an alternative to clean room for aseptic manufacturing: technical and economic evaluations Water and steam for aseptic manufacturing: features, plants, validation Case Study: validation of an aseptic filling line Case Study: Risk Analysis for an aseptic process CONV02 THE ISOLATORS: THE CHOICE BENEFITS (ADJUSTMENT, VALIDATION, MANAGEMENT) URS as a basis for a good design of an Isolator Using an Isolator for sterility tests as an alternative to the clean room: technical and economic evaluation Isolator Qualification. The Installation & Operational Qualification The bio-decontamination cycle development as a cross-link between Operational and Performance Qualification Isolator Qualification. The Performance Qualification Case Study: Using an Isolator for the injectable drugs aseptic manufacturing CONV04 LYOPHILIZATION: DESIGN, ADJUSTMENT, VALIDATION, MANAGEMENT The lyophilization process Product formulation and process development Technical aspects of a lyophilizer Qualification and Validation Maintenance aspects Recent FDA remarks about Lyophilization CONV05 EQUIPMENT QUALIFICATION AND METROLOGY IN THE PHARMACEUTICAL INDUSTRY Qualification Documentation: VMP, qualification protocols, final reports Validation steps: from DQ to PQ Practical management of Commissioning tests in Validation Scales and measuring instruments in qualification tests Qualification of existing process systems CONV03 AIR FLOW VISUALIZATION: THE IMPACT OF EQUIPMENT AND OPERATORS ON THE PROCESS QUALITY IN CLEAN ROOMS Unidirectional Flow and Clean Rooms: general aspects (regulations, air filtration, HVAC) and new requirements in compliance with the Annex 1 review Clean Devices (rooms LAF, isolators, RABS): solutions to obtain/manage a unidirectional flow (RABS, hoods, HVAC, etc.) Case Study: Smoke Study for unidirectional flow in at rest conditions Case Study: Smoke Study for unidirectional flow in operational conditions Case Study: behavior and process change in sterile and Smoke Study in operational conditions

13 On Demand Training Qualification & Validation Area CONV06 COMMISSIONING AND VALIDATION User Requirements Specifications, Functional Specifications, Design Qualification: aims and contents Practical management of Commissioning tests Engineering Documentation: layouts, material and personnel flows Qualification and Validation CONV07 METROLOGY AND MAINTENANCE APPLIED TO GMP GMP Manufacturing GMP in the field of Maintenance Basic Metrology - the calibration plan Hygiene & behavior rules in the Manufacturing area CONV08 MOIST AND DRY HEAT STERILIZATION Principles on moist heat sterilization Principles on dry heat sterilization Regulations and guidelines Validation and Testing Maintenance procedures and recurring problems CONV10 ANNEX15: NEWS ON PROCESS QUALIFICATION AND VALIDATION The new version of Annex 15: reasons for a deep review and main innovations Qualification of Plants and Equipment: the acquisition of the concepts of integrated C&Q approach and of "verification" proposed by the ASTM 2500 standard Process Validation: from the traditional approach to the Continuous Process Verification Cleaning Validation in the new version of the Annex15: news and confirmations The other aspects of validation: Change Control, Packaging, Transportation CONV11 THE LIFE CYCLE IN THE DESIGN, INSTALLATION AND QUALIFICATION OF CRITICAL UTILITIES FOR THE PHARMACEUTICAL WORLD Waters in the pharmaceutical industry: the regulatory framework Systems of water production and distribution: engineering aspects and critical parameters Issues related to microbiological growth within the systems of water production and distribution Steam for pharmaceutical use: tests on steam quality Process gases CONV09 CONTAMINATION CONTROL Pharmaceutical products protection from contamination Changes on the new EU GMP Annex 1 compared to the previous version. Regulatory and engineering consequences Cleanroom checks: tests based on ISO Particle and microbial contamination: the continuous samplers

14 REGISTRATION FEES BASIC TRAINING: IVA ADVANCED TRAINING: IVA BASIC TRAINING + ADVANCED TRAINING: IVA GXP TRAINING: IVA BASIC TRAINING ONLINE: IVA ON DEMAND TRAINING : 1, expenses + IVA The registration fee includes: - participation in the modules of the Course - documentation and certificate of participation - business lunches (where provided) PAYMENT Payment must be made in advance by BANK TRANSFER. Monthly invoice issue. The bank details are: BANCA NAZIONALE DEL LAVORO SPA - POGGIBONSI IBAN IT40V Please indicate the reason for payment and the course code. CANCELLATION Any cancellations must be communicated at least 5 working days before the event. Failure to comply with this deadline will result in the entire registration fee being charged. The replacement of the member is allowed. SUPPRESSION OR POSTPONEMENT CTP SYSTEM reserves the right to postpone or cancel the scheduled course if a minimum number of participants is not reached. The only obligation of CTP will be to return the registration fees already paid without additional charges or, at the request of the member, grant a bonus that can be used within the current year to access another event. G X P T R A I N I N G For more information on offers, discounts and subscriptions, visit and contact the CTP SYSTEM Training Office. W W W. C T P S Y S T E M. C O M

15 CTP SYSTEM can boast a consolidated training experience, created according to customer needs, constantly subject to critical comparisons with all that is really important in the world of pharmaceutical production. CTP SYSTEM fully satisfies the training request, has qualified partners such as the University of Siena, Pisa and Florence, Regione Toscana, and is specialized in the planning of courses financed by the European Social Training Fund of the Pharmaceutical Industry. The teaching and support staff is made up of expert GxP consultants, who are part of the CTP SYSTEM staff. The training offer is completed by external professional figures, such as teachers from the Italian Health Department (AIFA), with different specializations, characterized by an undisputed technical value. All these elements ensure a service fully compliant with the qualitative and normative standards required by European and extra-european regulatory authorities.

16 Info Click For information: NIKOLETA FOTIADOU Ph Mob W W W. C T P S Y S T E M. C O M We become: