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Risk Analysis, Quality Assurance, ISO 9001 and Business ...
Oct 01, 2013 · GMP Documentation and Record Keeping Course (useful for Section G) Week 1: A. Overview. Weeks 2,3: B. Submission Types. Weeks 4,5,6: C. Pre-Clinical Testing and Development. Weeks 7,8: D. Clinical Trials. Week 9: E. Pre-Submission Interactions with FDA . Weeks 10-12: F. Marketing Submissions and FDA Review. Weeks 13-15: G. Quality Systems
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[DOC File]Validation, Verification, and Testing Plan Template
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The period assigned for user training, operator training, maintenance and control group training, and management orientation briefing. The period assigned for preparation, review, and approval of the test analysis report. 3.x.2 Equipment Requirements.
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[DOC File]APPROVAL BLOCK - InstantGMP
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Move the PDF file and any interactive form/guides to the Signature folder. Quality Manager Ensure that the form/guide in the form/guide folder corresponds to the form/guide in the document. Sign and date the approval page approving both the form/guide and the SOP document. ... Filing Training Records File Training Records in accordance with the ...
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This is a sample Personal Protective Equipment Program of ...
The training will include an opportunity for employees to handle the PPE and demonstrate that they understand the training and have the ability to use the PPE properly. The training will be provided by the manager or supervisor of the affected employees. The training will be documented in writing with the documentation including the names of ...
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[DOC File]Good Manufacturing Practices (GMP’s) Policy
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Good Manufacturing Practices (GMP’s) Policy The purpose of this policy is to ensure compliance with current Good Manufacturing Practice (GMP) regulations for foods. It is the responsibility of all involved personnel at every level of the organization to act immediately if a risk of violating this policy is detected.
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[DOC File]BASIC (LEVEL 1)
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internal food safety training program. Company xyz table of contents. 0. Introduction 0-2. 1. Module 1: Hand washing 1-3. 2. Module 2: Glove Usage 2-7. 3. Module 3: Personnel Practices 3-8
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[DOCX File]GOOD MANUFACTURING PRACTICE (EMP) CHECK LIST
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Good Manufacturing Practice – GMP . Audit . Checklist. Sr. # (Contents) ... Is the technical staff, including supervisors and operations certified (and documented) in specialized training e.g. aseptic technique, sterilizing, washing, depyrogenation, visual inspection, standard operating procedure etc.
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[DOC File]USER REQUIREMENTS TEMPLATE
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The wide range filler shall be designed to meet the appropriate GMP regulations including cGMP 21 CFR part 210 and 211 as published at the time of order. ... Project Plan Paper or .pdf. Functional Specification Paper or .pdf. Design Specification Paper or .pdf ... Training. User training shall consist of 8 hours of classroom training and 16 ...
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Internal Audit Checklist Form
Potential causes could include customer requirements, the samples, sample specifications, methods and procedures, staff skills and training, consumables, or equipment and its calibration. 4.11.3 Selection and implementation of corrective actions a) Where corrective action is needed, the laboratory shall identify potential corrective actions.
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[DOC File]SkillsPlus International Inc.
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Mission Possible: GMP Training. November 1 - 5, 2009 - Orlando, FLorida. The GMP TEA Conference committee is accepting proposals for the 2009 conference. Presentations featuring tried and true techniques, the latest trends in training delivery and successful case studies are being requested. Back by popular demand are the facilitated discussion ...
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Gmp training pdf