Gmp Gdp In House Training-Books Pdf

GMP GDP In house Training
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GMP GDP In house Training Programme, Why In house Training Certificate of Attendance and. Our in house training courses help your employees to Documentation. put the GMP or GDP requirements into practice to As a recognised institution for advanced education. understand why they have to observe GMP GDP rules we issue certificates that document the participation in. and to develop a positive attitude towards GMP GDP the training and that are accepted by the supervisory. In the discussion of topical questions participants authorities. become familiar with the applicable rules and in, addition develop solutions to concrete problems In addition every participant receives an electronic ver. sion pdf files of the training documentation, This is an ideal training solution and cost effective. way to train a larger number of people than you,would normally want to send to an external course. We come to you at a time and date to suit your organ. Courses according to your Needs,Effective Remote Training.
Have you already considered GMP eLearning with,videos from pharmaceutical and API production. In addition to in house training courses you may also. use GMP eLearning courses with real life videos Please. The training courses are developed according to your check www gmp elearning com for more information. needs and ideas That means that they take into ac, count the specific situation in your company and the. latest GMP GDP publications That way your employ, ees benefit from trainings whose structure contents. and provided knowledge level are exactly tailored to. the target audience, In this brochure you will find some examples of the. training courses offered,Basic GMP Training,FDA Compliance in Quality Control.
Deviation Failure Investigation Annual product,Review and Change Control Management. GMP Audits Self Inspection,Regulatory Compliance for IT Professionals. Data Integrity,ICH Q7 Compliance,Good Distribution Practice. Good Storage Practice, Of course we will be glad to send you more proposals. Please use the form on the last page for your inquiry. www gmp compliance org,GMP GDP In house Training Programme.
Professional GMP Trainers, Our trainers have been working for us as speakers over many years Only GMP trainers who have performed. successfully at our open GMP Education Courses or European Conferences can conduct in house trainings on. our behalf Every specific field is covered by a different trainer This way we ensure that you have a competent. GMP trainer no matter if the course is about process validation computer validation about cleanrooms for. aseptic manufacture or any other topic, The following list contains only a few GMP Trainers which are involved in multiple customised training courses. DR RAPHAEL BAR DR HEINRICH PRINZ, Dr Bar headed the Analytical R D Laborato Heinrich Prinz can look back on many years. ries at Teva Pharmaceuticals and the analyti working for Boehringer Mannheim Roche. cal QC laboratory at Pharmos Today he Diagnostics and Biotest AG in both QA and. works as trainer and consultant QC,DR CHRISTOPHER BURGESS DR BERND RENGER. Chris Burgess is a chemist with more than Dr Renger was Director of QC at Vetter. 30 years experience in the pharmaceutical Pharma Fertigung He started his career at. industry which he mostly gathered in qual Hoechst AG as a research and development. ity assurance and analytical R D at Glaxo chemist Since then he held several. positions at Mundipharma Altana Pharma and Baxter, DR MARCEL GOVERDE He also is a Qualified Person under the permanent.
Mr Goverde led the QC Labs for non sterile provisions. product testing at F Hoffmann La Roche Ltd, and he worked as a QC expert for microbi DR WOLFGANG SCHUMACHER. ology at the chemical department of Dr Schumacher has more than 30 years ex. Novartis Pharma perience in the pharmaceutical Industry. At Hoffmann La Roche he established the IT, DR JOSEF M HOFER quality assurance department and was ac. Dr Hofer headed the department Interna countable in Technical Operations as Vice Director. tional Drug Regulatory Affairs of Klinge for the GMP CSV compliance of all global computer. Pharma in Munich Germany systems and the setup of the Data Integrity program. DR AFSHIN HOSSEINY DR PAUL STOCKBRIDGE, Afshin Hosseiny was Director of Quality As Dr Stockbridge spent 23 years with Eli Lilly. surance for the Global Supply Network of initially in fermentation development and. GlaxoSmithKline He also is a Qualified Per then in quality assurance He then moved to. son under permanent Provisions Aventis Pharma before being appointed. Corporate Quality Director for Cobra Biomanufactur. DR BOB MCDOWALL ing Plc He is now providing independent consulting. Analytical chemist with over 30 years experi and training services for the steriles aseptic and bio. ence including 15 years working in the technology industries. pharmaceutical industry with 2 multination,al companies DR INGRID WALTHER. Dr Walther has more than 25 years profes, GERT MOELGAARD sional experience in the pharmaceutical.
Gert Moelgaard has been Vice President for industry and in GMP consulting. Innovation Business Development in NNE,Pharmaplan,DR BETTINA PAHLEN. During the last 15 years she worked at uni,versity authority and in different areas of the. pharmaceutical industry R D manufactur,ing quality control quality assurance. Basic GMP Training,8 00 8 30 14 45 15 45, Welcome and Introduction Qualification and Validation. Definition and differences,8 30 9 30 Validation Master Plan.
Regulations in Europe Validation team,Directives Performance of validation. Guidelines Responsibilities,Notice to applicants,Regulations in the USA 15 45 16 45. CFR Change Management,Guidances Deviation,Freedom of Information Act Change control. Harmonised Regulations Out of Specification,ICH 16 45 17 15. GHTF Training and Self Inspection,ISO Performance of training.
Performance of self inspections,9 30 10 45 SOP,GMP in Manufacturing Documentation. Quality of starting material,Production process,Packaging and storage. Contract manufacturing We can also offer a two day training course. Responsibilities which includes Workshops,10 45 11 00 Break. 11 00 12 15,GMP in Quality Control,Duties of the quality control. Different regulations in the EU and USA,Qualified person.
Validation of analytical methods,12 15 13 15 Lunch. 13 15 14 30,Documentation,Batch documentation,Quality control documentation. GMP compliant documentation,14 30 14 45 Break,FDA Compliance in Quality Control. Day 1 Day 2,08 30 09 00 Welcome and Introduction 09 00 10 15. Stability Testing,9 00 10 30 Stability testing plan.
Regulatory Requirements in the Pharmaceutical Different kinds of testing. Industry Ongoing testing performance,FDA CFR Parts 200 600 Stability report. GMP Regulation WHO Europe, Duties of the quality control department 10 15 10 30 Break. Differences between quality control and quality,10 30 10 45 Break. 10 45 11 45,Documentation Requirements on Qualification and. Validation,Qualification validation policy,Validation Master Plan.
Documents for the performance of qualification,validation. Responsibilities,Presumption for qualification validation. Qualification validation report,11 45 13 00,Validation of Analytical Methods. ICH Guideline,SOPs for validation 10 30 11 45,How to write a validation plan SOP Documentation. Methodology and performance How to write a SOP,Content of a SOP.
13 00 14 00 Lunch Nuts and bolts of SOPs,GMP compliant control of the documentation. 14 00 15 15 Archiving,Out of Specification OOS,The Barr Case 11 45 13 00. FDA Guideline on OOS Self Inspection Auditing,Out of Specification SOP Inspection program. Failure Investigation Inspection plan,Performance of an inspection. 15 15 15 30 Break Dos and don ts,Supervision of external contractors.
15 30 16 30 Inspection report,Sampling Qualification of auditors. Sampling plan,Performance of sampling 13 00 14 00 Lunch. Pitfalls and failures of sampling,SOP for sampling 14 00 15 00. 16 30 17 15 Training Plan,Batch Release Training SOP. SOP for batch release Performance of Training,How to document the release process.
Responsibilities 15 00 15 30 Discussion, 17 15 17 45 Discussion We also offer further training courses for QC personnel e g on. Stability Testing,Out of Specification OOS Handling. Deviation Failure Investigation, Annual Product Review and Auditing Self Inspection. Change Management,8 00 8 30 8 00 8 30,Welcome and Introduction Welcome and Introduction. 8 30 9 30 8 30 9 30, Regulatory Requirements in Europe and the US Regulatory Requirements.
EU GMP Guide,9 30 10 30 21 CFR 211,Out of Specification OOS Harmonised requirements. The Barr Case Differences between audit and self inspection. OOS Failures,Handling of OOS results 9 30 10 30,Audit Programme and Planning. 10 30 10 45 Break How to define an audit schedule,Identify priorities. 10 45 11 45,Deviation and Changes 10 30 10 45 Break. Differences between deviations and changes,Occurrence of deviations and changes 10 45 11 45.
Handling of deviations and changes Preparation for an Audit. Communication with the auditor auditee, 11 45 12 45 Internal and external planning of an audit. Root Cause Analysis,How to perform a root cause analysis 11 45 13 00. Involvement of other departments Realisation of an Audit. How to prepare an audit schedule,12 45 13 45 Lunch Performance of an audit. Questions and answers,13 00 13 45 Lunch,13 45 14 45. Audit Report,Wrap up meeting,Writing an audit report.
Follow up of findings,483s Warning letter,14 45 15 00 Break. 13 45 14 45 15 00 16 00, Assessment of Deviation and Changes Nuts and Bolts of an Audit. Risk analysis Failures of auditors,Outcome of the assessment Failures of auditees. Necessary actions related to other products Differences between European and FDA audits. and batches,16 00 17 00,We also offer 2 and 3 days. 14 45 15 00 Break Qualification of Auditors,auditing courses with.
practical case studies,15 00 16 00 17 00 17 30 Discussion. Trending Annual Product Review,Assessment and trending of changes and deviations. Content of the report,16 00 17 00,Change Management System. Change management as part of the quality,management system. Involvement of contract manufacturer,17 00 17 30 Discussion.
Regulatory Compliance Requirements for Data Integrity. for IT Professionals in GMP Laboratories, 08 40 09 00 Welcome and Introduction 09 00 09 15 h Introduction to Course and Instructor. 09 00 10 00 09 15 10 15 h, The Regulators Requirements Why is Data Integrity Important. What you Need to Know,10 15 10 45 h,10 00 11 00 Role of Management in Data Integrity. Computer Validation What is Required,10 45 11 00 h Break. 11 00 11 15 Break,11 00 11 45 h,11 15 12 15 Principles of Data Integrity.
How do the Regulations Impact on an IT Department,12 15 13 15 Lunch. 13 15 14 15,Qualifying a Network and IT infrastructure. 14 15 15 15,Regulatory Compliance Issues that must be. Considered when Outsourcing your IT Operations,15 15 15 30 Break. 15 30 16 30,Auditing IT Operations,16 30 17 00 Discussion.
11 45 12 30 h,US 21 CFR 211 and EU GMP Chapter 4,Complete data versus raw data. 12 30 13 30 h Lunch,13 30 14 15 h,Ten Compliance Commandments for Laboratory. 14 15 15 30 h,Facilitated Discussion Workshop on Key Data. Integrity Topics,15 30 15 45 h Break,15 45 16 45 h. Workshop Developing a Data Integrity Plan, Are you looking for an individual training course on 16 45 h.
computer validation Please contact us we will be Key Learning Points and Final Discussion. glad to develop a training course that will meet your. demands More on Data Integrity,We also can offer,2 days training courses. Data Integrity in Production,Audit Trail Review,Good Distribution Practice Good Storage Practice. 09 00 09 30 h, 08 00 h Welcome Introduction Presentation of the Speaker. Introduction,08 30 09 30 h, 08 15 h Regulatory Requirements of Good Storage Practice. International Regulations Requirements related to Europe. Storage and Transportation USA,Other regulations and guidelines.
European Regulatory Requirements and Guidance,09 30 10 30 h. 10 30 h Coffee Break Good Storage Practice,Facilities and equipment. 11 00 h Environmental monitoring,Best Practices in Storage Product handling. Maintenance,12 15 h Lunch,Workshop Session 1 10 30 10 45 h Break. Deviations in the Supply Chain, What are the data telling us How to assess deviations 10 45 11 45 h.
What CAPAs are effective Documentation,15 00 h Coffee Break Electronic and paper records. Monitoring of the storage conditions,15 30 h Computerised systems. Q A Responses to the pre submitted questions,11 45 12 45 h. Day 2 Operations,Maintenance,08 00 h Control of incoming material. Cold Chain Management and its Validation Release, Best practices in Transport and Logistics 12 45 13 45 h Lunch.
10 00 h Time for Discussion 13 45 14 45 h,Management of Returned Goods. 10 15 h Coffee Break Different storage areas,10 45 h Measures necessary. Workshop Session 2 Links to other department,The Selection of the best Supply Route. 12 45 h Lunch 14 45 15 00 h Break,13 45 h 15 00 16 00 h. Security in the Supply Chain Frequently found Failures Warning Letters. 14 30 h 16 00 16 30 h Discussion,Track and Trace and anti counterfeiting Devices.
15 15 h Coffee Break,15 45 h Final Discussion Q A,ICH Q 7 Compliance for APIs. Day 1 Day 2,9 00 9 15 9 00 10 30, Introduction and expectations for the two days API Workshop What to do if. An interactive workshop on a scenario dealing with. 9 15 10 15 batch dispositions,GMP Requirements, General overview of Regulations EU US and others 10 30 11 00 Coffee break. Introduction of ICH,ICH Q7 in general 11 00 12 00, ICH Q7 for chemical APIs for biotech APIs Process Validation. Purpose of process validation, 10 00 10 15 Break Prospective concurrent and retrospective.
validation approaches,10 45 11 30 Process validation protocol design. GMPs for APIs through Product Lifecycle Dos and don ts in process validation. Process knowledge and cGMP Revalidation of processes. Key compliance issues Change control and process validation. 11 30 12 15 12 00 13 00, Change Control through the Product Lifecycle Cleaning Verification or Validation. Changes Good or bad Forced or voluntary Cleaning requirements and cleaning methods. The Importance of Change Control Cleaning verification versus validation. Scope and Responsibilities Acceptance levels, General requirements Cleaning validation approaches in mono vs. Detailed requirements for Specific Changes multipurpose environments. Implementation of Changes Monitoring of cleaning effectiveness after validation. 12 15 13 15 Lunch 13 00 13 15 Discussion and Q A,13 15 14 00. Supplier Qualification and Procurement,ICH Q7 requirements.
Supplier qualification covering the full supply chain. One strategy for supplier qualification from non,critical raw material to API. Requirements and strategy for reduced testing,CoA release of materials. 14 00 15 00,Deviation and Failure Investigation,Definitions and basic requirements. Scope and responsibilities,Detailed requirements,Principles of justification for deviations. A quick look on Root Cause Analysis, The role of the quality unit for handling deviations.
and justification,15 00 15 30 Coffee break,15 30 16 45. GMP Scenarios an interactive Workshop,16 45 17 00 Discussion and Q A. GMP GDP In house Training Programme,Basic GMP Sterile Manufacture. Basic GMP Production of Sterile Pharmaceuticals,Quality Control Solid Dosage Form Manufacture. FDA Compliance in analytical Quality Control Tablet Manufacturing and Validation. Stability Testing in the Pharmaceutical Industry, Out of Specification Results Good Clinical Practice.
Basic Course in Good Clinical Practice,Quality Assurance. Data Integrity Medical Devices, Deviation Failure Investigation Annual Product Regulatory Requirements for Medical Devices. Review and Change Management,Auditing Self Inspection APIs. Quality Assurance Systems Based on ISO 9001 and ICH Q7 Compliance. Change Management Changes and Deviations Regulatory Affairs. GMP and FDA Compliance in Quality Assurance Units Marketing Authorisations and Post Approval. Pharmaceutical Quality Systems Obligations in the EU. Hygiene Training Course Quality Data in the Marketing Authorisation. Application,Good Distribution Practice GDP Quality by Design. Good Distribution Practice Storage Transportation,Cold Chain.
Good Storage Practice, You will find a time schedule for each training course. IT Computer Validation at www gmp compliance com button Training. Regulatory Compliance for IT Professionals, Validating Computerised Analytical Equipment and We also offer in house training courses for Qualified. Systems Persons Please contact us for more information. Electronic Records and Electronic Signatures 21 CFR info gmp compliance org. We will be happy to design further GMP training, Validation Qualification courses for you on request. Qualification and Validation of Equipment and,Processes in Laboratories and Manufacturing. Basic GMP Training Qualification Validation, Cleaning Validation in Pharmaceutical Drug Product.
and API Production, If you are interested in one of our in house training courses please contact us and we will prepare a quotation for you. Title first name surname,Department,Street P O Box. City Zip Code,ECA Academy,P O Box 10 21 68,69011 Heidelberg Germany. info gmp compliance org,www gmp compliance org E Mail Please fill in.


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