Thu September 24, 2015
A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs) | Webinar
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Topic ID: 000000198-web
Start Date: Sep 24, 2015
Start Time: 10 AM PST | 1 PM EST
Name of Event: A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs) | Webinar
Details: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. The course will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. The course instructor will offer guidance on how to get from regulations to the SOP.
Areas Covered In The Session:
SOPs and their relation to the regulations.
SOPs as part of the company's regulatory infrastructure.
SOP on SOPs and how to ensure conciseness, consistency and ease of use.
Risk based approach on SOP best practices for creation and maintenance.
Training on SOPs.
Tools for SOP tracking and when is validation required.
What the FDA looks for in SOPs during an inspection.
Speaker: Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Lifescience industry.
For more details call Complystream at: (+1) 844 498 6361
show less
Start Date: Sep 24, 2015
Start Time: 10 AM PST | 1 PM EST
Name of Event: A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs) | Webinar
Details: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. The course will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. The course instructor will offer guidance on how to get from regulations to the SOP.
Areas Covered In The Session:
SOPs and their relation to the regulations.
SOPs as part of the company's regulatory infrastructure.
SOP on SOPs and how to ensure conciseness, consistency and ease of use.
Risk based approach on SOP best practices for creation and maintenance.
Training on SOPs.
Tools for SOP tracking and when is validation required.
What the FDA looks for in SOPs during an inspection.
Speaker: Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Lifescience industry.
For more details call Complystream at: (+1) 844 498 6361
Topic ID: 000000198-web
Start Date: Sep 24, 2015
Start Time: 10 AM PST | 1 PM EST
Name of Event: A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs) | Webinar
Details: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. The course will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. The course instructor will offer guidance on how to get from regulations to the SOP.
Areas Covered In The Session:
SOPs and their relation to the regulations.
SOPs as part of the company's regulatory infrastructure.
SOP on SOPs and how to ensure conciseness, consistency and ease of use.
Risk based approach on SOP best practices for creation and maintenance.
Training on SOPs.
Tools for SOP tracking and when is validation required.
What the FDA looks for in SOPs during an inspection.
Speaker: Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Lifescience industry.
For more details call Complystream at: (+1) 844 498 6361
read more
Start Date: Sep 24, 2015
Start Time: 10 AM PST | 1 PM EST
Name of Event: A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs) | Webinar
Details: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. The course will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. The course instructor will offer guidance on how to get from regulations to the SOP.
Areas Covered In The Session:
SOPs and their relation to the regulations.
SOPs as part of the company's regulatory infrastructure.
SOP on SOPs and how to ensure conciseness, consistency and ease of use.
Risk based approach on SOP best practices for creation and maintenance.
Training on SOPs.
Tools for SOP tracking and when is validation required.
What the FDA looks for in SOPs during an inspection.
Speaker: Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Lifescience industry.
For more details call Complystream at: (+1) 844 498 6361
show less
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