We are proud of our new service, cGMP Certification Audits, and are anxious to share it with you! You can learn more about it at https://lnkd.in/gKw3fvng. #cGMP #ComplianceAudit #cGMPCertificate #Consultants #GMP #Auditors
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What do we mean when we say that CSQ is an 'Accredited Standard?' It means that our Certification Body, auditors, and technical review process meet certain requirements that aren't at all necessary for a run-of-the-mill cGMP audit. cGMP audits are unaccredited; any auditor can perform an audit without oversight from a Certification Body. If you are still trying to decide what's best for your facility- take a look at this graphic which pinpoints all the major differences. #cgmp #accredited #cannabisproducts
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Gain expertise in the updated AAMI TIR48:2024 for Combination Products through AAMI Training! Key Updates: AAMI TIR48:2024 – QMS Recommendations for Combo Products 📅 May 9 | 1:00 pm - 4:00 pm ET | Virtual AAMI TIR48:2024 reflects changes in regulations and guidance for applying the US FDA cGMP Final Rule on #CombinationProducts. This training provides insights and best practices for understanding and applying Combination Products cGMP expectations, aiding informed decision-making. Topics include key terminology, examples, and considerations for a "Streamlined Approach" and Inspection Readiness. Presenter: Susan Neadle, Principal Consultant & President, Combination Products Consulting Services LLC Learn more here: https://lnkd.in/e6_drPgP #AAMITraining #Compliance #RegulatoryCompliance #MedicalDevices
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Gain expertise in the updated AAMI TIR48:2023 for Combination Products through AAMI Training! Key Updates: AAMI TIR48:2023 – QMS Recommendations for Combo Products 📅 March 27 | 1:00 pm - 4:00 pm ET | Virtual AAMI TIR48:2023 reflects changes in regulations and guidance for applying the US FDA cGMP Final Rule on #CombinationProducts. This training provides insights and best practices for understanding and applying Combination Products cGMP expectations, aiding informed decision-making. Topics include key terminology, examples, and considerations for a "Streamlined Approach" and Inspection Readiness. Presenter: Susan Neadle, Principal Consultant & President, Combination Products Consulting Services LLC Learn more here: https://lnkd.in/gZS5Yh4G #AAMITraining #Compliance #RegulatoryCompliance #MedicalDevices
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Quality Audits, Inspections & Compliance, Quality Assurance Manager, Corporate Quality Assurance, QMS, External Manufacturing Quality, Vendor Audit Management
FDA issues white paper on prototype assessment protocol for Quality Management Maturity program. Development of a prototype assessment protocol covering five practice areas: 1. Management Commitment to #quality 2. Business #Continuity 3. Advanced Pharmaceutical Quality System (PQS) 4. Technical Excellence 5. Employee Engagement and Empowerment Note: QMM assessments are not used to evaluate compliance with CGMP. QMM assessments are not part of FDA’s inspection authority and participation in the QMM program is voluntary. The QMM assessment cannot be used to determine compliance with CGMP. QMM assessments focus on evaluating the behaviors, practices, and quality culture within an establishment. Higher levels of QMM indicate a higher #processcapability and #performance and a reduced risk of quality failures that can contribute to drug shortages. #qmmfocus The QMM assessment will identify areas of strength in quality management practices and provide recommendations for impactful growth opportunities. #QMM #FDA #CDER
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Quality Audits, Inspections & Compliance, Quality Assurance Manager, Corporate Quality Assurance, QMS, External Manufacturing Quality, Vendor Audit Management
#Webinar organized by #FDA administration on "Understanding FDA Inspections and Data" in which important topics were explained in detail i.e. FDA inspection model, contributory risk factors for the selection of site inspection, reporting of inspectional finding, site response review and Data Integrity governance. 1.) Applicable Manufacturing Standards. 2.) Understanding CGMP Inspections and 483s. 3.) How FDA Reviews Inspectional Findings. 4.) FDA Regulatory Actions. 5.) Where to find inspection and other compliance documents. #cder #fda #compliance #businesscontinuity #essentialdrugs
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💎 Customized in-house courses for Pharma and Biotech 💎 Partnering with Top Industry Experts 💎Trusted by 150+ companies
Looking to enhance your expertise in GMP compliance? Check out this valuable course from Symmetric Training! Ideal for professionals working on the development of the GMP Lead Audit, this course provides a comprehensive understanding of GMP principles, regulatory requirements, audit plans, checklists, and reports, classification of audit findings, and practical auditing skills. By taking this course, you can empower yourself to contribute effectively to maintaining and improving the quality of products in regulated industries. Don't miss out on this opportunity to enhance your skills and knowledge! #GMP #EMA #FDA #compliance #onlinecourses #Pharma #SymmetricTraining
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Ensure pharma project success with our expert EPCM consultancy services. We provide comprehensive support, adhering meticulously to regulatory and CGMP standards. From planning to operations, we ensure top-notch results and unwavering compliance. #quantum #PharmaIndustry #consultancy #comprehensive #CGMP #compliance
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GMP/GDP Global Advisor l CEO l Founder of Largest Pharma/Biotech Quality LinkedIn Group l Motivational Speaker
A Detailed GMP Quality Audit Questionnaire Remember to structure your questionnaire to include an assessment of.... ✅QMS ( licenses/certifications, CAPA, change control, RA, APQR, QMR....) ✅Personnel (key people, training & development) ✅Documentation ( ALCOA, document lifecycle management) ✅Premises & Equipment ( Validation, Qualification, maintenance & records) ✅Operations (Manufacturing controls and batch documentation) ✅incidents handling (deviations, complaints, recalls, returns, counterfeits) ✅Audits & inspections (internal & external) ✅Contracted services (Vendor qualification - GMP materials and services, QTAs). If you would like to learn more on this topic, please like, share and follow me on LinkedIn. #gmp #audit #quality #questionnaire #pharmaceutical #biotechnology #cellandgenetherapy
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#GMP and #cGMP are two of the most important frameworks for our industry – but while they seem similar, there are important differences to be aware of when it comes to aseptic manufacturing. 💉 Our latest blog takes a deeper look at the principles of GMP and cGMP and provides some valuable insights on: • Key differences between GMP and cGMP to consider • Where to begin in your compliance journey Gain a better understanding of these critical guidelines and plan with even greater confidence with this new insight linked in the comments. ⤵️ #GMP #cGMP #compliancestandards #drugdelivery #CDMO #VetterPharma https://lnkd.in/eSzu3WN6
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A short and insightful article on the importance of adhering to cGMP.
#GMP and #cGMP are two of the most important frameworks for our industry – but while they seem similar, there are important differences to be aware of when it comes to aseptic manufacturing. 💉 Our latest blog takes a deeper look at the principles of GMP and cGMP and provides some valuable insights on: • Key differences between GMP and cGMP to consider • Where to begin in your compliance journey Gain a better understanding of these critical guidelines and plan with even greater confidence with this new insight linked in the comments. ⤵️ #GMP #cGMP #compliancestandards #drugdelivery #CDMO #VetterPharma https://lnkd.in/eSzu3WN6
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