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QA AND GMP TRAINING
Training programs require multiple levels to address the ranging complexities of different roles, responsibilities and requirements. SeerPharma provides scalable training offerings across Quality Assurance (QA) and Good Manufacturing Practice (GMP) topics from entry-level induction training, to targeted upskilling and professional development, through to postgraduate qualifications. CLEANING VALIDATION FOR PHARMACEUTICAL GMP The FDA's Industry Guidance document "Validation of Cleaning Processes (7/93)" stood alone for virtually 20 years. Since then and particularly in the period 2016-2020, we have seen significantly more guidance being published from key industry bodies including the EMA, PIC/S, PDA, ISPE, and WHO. COMPUTER SYSTEM ASSURANCE (CSA) SUPPLIER QA TRAINING 4. Establishing controls. 5. Delivery, measurement and monitoring. 6. Feedback and communication. Establishing supplier risk ratings and evaluation criteria. Structure and content of the Supplier Quality Agreement. When the supplier is part of your organisation – Quality Agreements and the role of QA.SUPPLIER MANAGEMENT
As engineering teams develop new designs, contract manufacturers and parts must be identified and added to the AVL. To be placed on the AVL, a supplier management system must be monitored on an ongoing basis and must successfully fulfill a number of qualifications, such as supplier surveys, supplier audits, and process validation. HOW TO PREPARE FOR AN INSPECTION / AUDIT SP6538: How to Prepare for an Inspection / Audit. For pharmaceutical, animal health and medical device organisations, preparing for and working through regulatory inspections or audits from the TGA, APVMA, ACVM and Medsafe can be harrowing. Whether your organisation is large or small, there is a tremendous amount of (virtual and perceived GMP DATA INTEGRITY TRAINING SP6524: GMP Data Integrity – Identify and Address Your Vulnerabilities. Data Integrity (DI) is a hot topic in the industry because Regulators are focusing on it. Demonstrable integrity of data/records has been a long-standing GMP requirement, it is not new. With the flood of industry guidance on DI since 2016 (from the FDA,WHO, MHRA, PIC/S
PQR TRAINING
This course will help you determine the adequacy of the manufacturing controls and product specifications you have in place. The training will address: PQR procedures, documentation and records. How to review production records and stability studies. Identifying trends andpotential problems.
LEARNING MANAGEMENT SYSTEM (LMS) FOR PHARMACEUTICALS Learning Management System (LMS) for Pharmaceuticals & Medical Devices. In the Pharmaceutical and Medical Device industries, employees can affect product quality so they must be trained and assessed on a variety of documents (policies, SOPs etc.) and tasks relevant to their job role . As a Training Manager your paper-basedsystem requires you
SEERPHARMA | LEADERS IN QUALITY AND GMP SOLUTIONSABOUT USINDUSTRIESSERVICESMASTERCONTROLCONTACT USPHARMACEUTICALS Contact SeerPharma for integrated and compliant Quality and GMP solutions with Consulting, Training, MasterControl and Contracting services and products.QA AND GMP TRAINING
Training programs require multiple levels to address the ranging complexities of different roles, responsibilities and requirements. SeerPharma provides scalable training offerings across Quality Assurance (QA) and Good Manufacturing Practice (GMP) topics from entry-level induction training, to targeted upskilling and professional development, through to postgraduate qualifications. CLEANING VALIDATION FOR PHARMACEUTICAL GMP The FDA's Industry Guidance document "Validation of Cleaning Processes (7/93)" stood alone for virtually 20 years. Since then and particularly in the period 2016-2020, we have seen significantly more guidance being published from key industry bodies including the EMA, PIC/S, PDA, ISPE, and WHO. COMPUTER SYSTEM ASSURANCE (CSA) SUPPLIER QA TRAINING 4. Establishing controls. 5. Delivery, measurement and monitoring. 6. Feedback and communication. Establishing supplier risk ratings and evaluation criteria. Structure and content of the Supplier Quality Agreement. When the supplier is part of your organisation – Quality Agreements and the role of QA.SUPPLIER MANAGEMENT
As engineering teams develop new designs, contract manufacturers and parts must be identified and added to the AVL. To be placed on the AVL, a supplier management system must be monitored on an ongoing basis and must successfully fulfill a number of qualifications, such as supplier surveys, supplier audits, and process validation. HOW TO PREPARE FOR AN INSPECTION / AUDIT SP6538: How to Prepare for an Inspection / Audit. For pharmaceutical, animal health and medical device organisations, preparing for and working through regulatory inspections or audits from the TGA, APVMA, ACVM and Medsafe can be harrowing. Whether your organisation is large or small, there is a tremendous amount of (virtual and perceived GMP DATA INTEGRITY TRAINING SP6524: GMP Data Integrity – Identify and Address Your Vulnerabilities. Data Integrity (DI) is a hot topic in the industry because Regulators are focusing on it. Demonstrable integrity of data/records has been a long-standing GMP requirement, it is not new. With the flood of industry guidance on DI since 2016 (from the FDA,WHO, MHRA, PIC/S
PQR TRAINING
This course will help you determine the adequacy of the manufacturing controls and product specifications you have in place. The training will address: PQR procedures, documentation and records. How to review production records and stability studies. Identifying trends andpotential problems.
LEARNING MANAGEMENT SYSTEM (LMS) FOR PHARMACEUTICALS Learning Management System (LMS) for Pharmaceuticals & Medical Devices. In the Pharmaceutical and Medical Device industries, employees can affect product quality so they must be trained and assessed on a variety of documents (policies, SOPs etc.) and tasks relevant to their job role . As a Training Manager your paper-basedsystem requires you
QUALITY AND GMP SOLUTIONS Company Background. SeerPharma is a team of consultants that provide best-practice advice, training, software solutions from MasterControl, and contract labour resources to pharmaceutical, medical device and life science companies in the Asia-Pacific region on matters of Quality and GMP compliance.GMP ELEARNING
GMP Induction and Refresher Training Solution. SeerPharma's GMP eLearning courses are designed, developed and maintained entirely in-house so we can be your 1-stop-shop for GMP induction and refresher training.You can choose any single or combination of ourMASTERCONTROL
MasterControl Inc. was founded in 1993 as a document control solution provider. Since that time, the company has grown significantly. Their offerings enable regulated companies to accelerate compliance and get to market faster while reducing costs and improving efficiency. At present, more than 800 customers, with more than 1,000 customer sitesPQR TRAINING
This course will help you determine the adequacy of the manufacturing controls and product specifications you have in place. The training will address: PQR procedures, documentation and records. How to review production records and stability studies. Identifying trends andpotential problems.
GMP DATA INTEGRITY TRAINING SP6524: GMP Data Integrity – Identify and Address Your Vulnerabilities. Data Integrity (DI) is a hot topic in the industry because Regulators are focusing on it. Demonstrable integrity of data/records has been a long-standing GMP requirement, it is not new. With the flood of industry guidance on DI since 2016 (from the FDA,WHO, MHRA, PIC/S
SUPPLIER MANAGEMENT
As engineering teams develop new designs, contract manufacturers and parts must be identified and added to the AVL. To be placed on the AVL, a supplier management system must be monitored on an ongoing basis and must successfully fulfill a number of qualifications, such as supplier surveys, supplier audits, and process validation. QUALITY RISK MANAGEMENT (QRM) TRAINING The Quality Risk Management Toolbox: what to use and when. Case studies drawn from the following real life scenarios will be workshopped to provide you with both industry examples and hands-on practice in the use of three of the more complex process risk assessment tools (defined in ICH Q9) – PHA, FMEA, HACCP: Bioburdenrisks in the
RELEASE FOR SUPPLY TRAINING Content. As regulators increase their attention on release for supply processes and personnel, SeerPharma is supporting industry with this dedicated Release for Supply training course. You will learn the duties and responsibilities of Authorised Persons within the context of the Australian regulatory framework and improve your understandingof
SEERPHARMA BLOG
post-market surveillance | Stories of how we help pharmaceutical & medical device companies with QA & GMP consulting, training, IT solutions and contracting to deliver confidence in compliance. RATIONAL GMP ENVIRONMENTAL MONITORING Environmental monitoring (EM) of a GMP facility may be conducted for a variety of reasons. The major reasons for conducting EM are to assess the effectiveness of the cleaning program and to assess the impact of the environment on product quality. Australia+61 3 9897 1990 Singapore+65 6774 5800UK+44 1347 833 101
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