Overview QbD Training Package

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Transcript of Overview QbD Training Package

GDP Good Distribution Practice

Quality assurancein the pharmaceuticalmedical device & biotech industry

Overview Training 2017

#QbD AcademyAt QbD, we like to pass our expertise on to our clients and partners. Thats why we offer training and coaching for companies, small groups and individuals. When you participate in a QbD in-company training, youre assured thattraining is in line with your company and your individual training needsyoure flexible in terms of time and locationyou receive a tailor made offer based on your needs

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#Organisational proposal

#QbD Training Overview 2017Audit training Introduction in RegistrationIntroduction in QMSGood Manufacturing Practices (GMP) Good Distribution Practices (GDP)Good Laboratorical Practices (GCP) Introduction in Validation Basics Acceptance Sampling Design of Experiment (DoE)

Quality by Design (QbD)GAMP5 Intro Serialisatie Tech TransferISO 13485 Medical Device

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#Why?Within the (bio-)pharmaceutical industry, the quality of the manufactured products must be guaranteed at all times. In the past, a number of rules or good practices were developed in this regard, by both legal authorities and the sector itself. Vigilance and continuous improvement of processes as well as in the development of drugs are required.For whom? This workshop is intended for anyone who has recently started in the pharmaceutical industry and wishes to learn more about the expectations placed on the goods produced according to GMP. No prior knowledge is required.All participants who attend the complete workshop receive a certificate.Duration?1 day training and workshop

ProgramThe concept of quality within the pharmaceutical industryStandards and normsPharmaceutical legislationInspections and authoritiesDrug registrationICH GMP content, meaning and requirementsPrinciplesDivision of ICH GMP guidelinesRequirements placed on employees and resourcesRequirements placed on production and controls Complaints and recallsInternal auditsOther expectations

Good Manufacturing Practices

#Why? The new European guidelines on Good Distribution Practice (GDP) of 5 November 2013 set out the rules to help the industry face the latest challenges, such as the rise in counterfeit medicines. The adoption of this regulation by all players involved in the storage and distribution of medicines is increasingly monitored by governments.For whom?The new European guidelines on Good Distribution Practice (GDP) of 5 November 2013 set out the rules to help the industry face the latest challenges, such as the rise in counterfeit medicines. The adoption of this regulation by all players involved in the storage and distribution of medicines is increasingly monitored by governments.Duration1 day training with workshop and Q&A session

ProgramIntroduction in GDPWhy GDP?What are the expectations from the government?Who has to be compliant with these GDP guidelines?The EU GDP guidelinEPrinciplesQuality systemsPersonnel & trainingFacilities & equipmentDocumentationOperationsComplaints and recallsInternal auditsDistribution of pharmaceutical products

Good Distribution Practices

#Why?GLP tries to provide organisations with a quality assurance system to ensure, among other things, that the data generated in the laboratory are reliable and traceable. This requires a specific modus operandi that makes knowledge of GLP necessary for each employee. The rules must be followed. They are discussed in this training but it is also explained why they are set up in this way.For whom?You work in a regulatory environment, or will shortly be working in a quality laboratory that has to deal with GLP.Note: the instructors have no experience of animal testing and this aspect of GLP is not dealt with in the courseDuration?1 day trainingProgramIntroductionLegislationGLPDefinitionsOrganisation/staff: training, hygieneProgramme for quality controlFacilities in a laboratory environmentEquipment (possibly software-controlled) and material: calibration, qualification/validationTest and reference materialAnalytical methods and validations (Pharmacopoeia): materials and reagents, specifications and out of specifications (OOS), change of controlWork instructions SOPCarrying out the researchReporting and storage of dataLoss of qualification

Good Laboratorical Practices

#Why?Validation is a way to prove that a system or process works correctly, and complies with fixed acceptance criteria. Each pharmaceutical or cosmetic product needs a quality control process to guarantee that the products meet quality requirements and comply with regulations. A validation process results in a file with certifications that prove to auditors that, by means of various tests, you comply with the required criteria.For whom?This training is intended for people in the life sciences (especially pharmaceuticals) or cosmetics sector with little or no experience in validation and are planning to get busy with validation.Duration1 day training

ProgramLearn the basic principles of and discuss the possibilities for your validation process.Gain insight into the best start for your validation process and required information and equipment.Learn the definition of validation related terms, like URS certification, impact assessment or risk analysis.Discover how to design a validation test.In addition to this training, we offer a Pharmaceutical Engineer training to extend your knowledge to the technical aspects. We also explore the subject and the issues we are facing in the field in greater detail. This may lead to internal or external assignments.

Introduction in Validation Basics

#Why?Every company that makes products for the European or American market is subject to the laws of the EMA (European Medicine Agency), FDA (Food & Drug Administration) and/or FAMHP (Federal Agency for Medicines and Health Products). These include GMP (Good Manufacturing Practices, also known as Predicate Rules), 21CFR Part 11 and/or Annex 11. For whom?This training is intended for anyone involved in the development/implementation of production systems for the pharmaceutical sector, the cosmetics industry, the food industry or related sectors where quality is an important factorDuration?2 day training

ProgramIntroductionISPEWorkflow of systems: V modelPhasingDesign and ValidationRisk-Based Approach and ASTM E2500Commissioning & QualificationTasks and responsibilitiesMaintenance of validated systemsRisk ManagementWhat requirements are placed on staff?How to deal with suppliers and subcontractors?What tasks are expected in the various project phases?

System validation / Qualification

#Why? GAMP is a practical interpretation of this legislation and can be regarded as a structured and project-based approach for the validation of (automation) systems. In fact, this approach includes various working methods that could generally be considered good practice. For whom?This training is intended for anyone involved in the development/implementation of automated production systems for the pharmaceutical sector, the cosmetics industry, the food industry or related sectors where quality is an important factor.Duration? 2 day training

ProgramIntroductionFDA, EMA and regulationsISPE

GAMP 5Workflow of automation systems: V modelDifferences compared to GAMP 4PhasingDesign and validation

21CFR Part 11Electronic recordsElectronic signaturesAudit trailPractical interpretation

Annex 11Risk managementWhat requirements are placed on staff?How to deal with suppliers and subcontractors?What tasks are expected in the various project phases?

GAMP5

#Why?After the training, participants will understand; the roles and responsibilities of the sending unit, the receiving unit and the project team, the various phases within a Tech Transfer project, the main pitfalls and threats to quality, the regulatory impact of the main types of transfer.Afterwards, participants can independently; fulfil their own role within the team, spot potential problems and make proposals for improvements, estimate the regulatory impact of changes.For Whom?Employees of small and large companies faced with technology transfer,Project managers of technology transfer projects,The training focuses on technology transfer within the pharmaceutical industry.Duration?4-hour or 8-hour training. ProgramDuring the 8-hour training, a number of workshop elements are provided that focus on the specific situation of the course participant(s). While for the 4-hour training, the focus is mainly on theory and independently learning to find additional information.

Tech Transfer

#Why?The aim of this training is to acquire an understanding of the various audit processes and provide tips so that you are in a position to both successfully carry out and undergo an auditFor whom?In particular, new QA operatives wanting to broaden their base.Duration?1 day training

ProgramTheoryQuality systemsStandards relating to auditsTypes of audit, the people involved and SOPsThe general audit processAuditor skills and climateDiscussion of different audits- Exercises (tools)- Test

Audit Training

#Why?Falsified medicines are a serious threat to patients all over the world. More and more governments are therefore enacting new legal requirements to enforce anti-counterfeiting measures in the supply chain. This legislation poses a bigchallenge in addition to significant costs to organisations that manufacture, distribute and sell drugs, as they seek to comply with the mandates.For whom?This training is intended for people involved in the packaging of pharmaceuticals who are facing current and upcoming legal requirements for serialisation and track & trace.Duration?Half-day training and discussion

ProgramAcquire a