Transitioning from NON-GMP to cGMP manufacturing or CRO Services
GMP Structure cGMP Structure www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile:
Neal H. Wright has 35+ years of experience in Life Sciences including, 25+ years as Quality Assurance Specialist for cGMP CRO CMO, CMC & ISO Manufacturing, and CLIA QA and Regulatory Compliance including, Quality Management Systems (QMS) -Design, Implementation, Review, Revision, remedial services. IQ OQ PQ Instrumentation Qualifications, QC Bioanalytical Methods Development & Validation, API Purity & Stability programs, Microbiology Testing: Sterility, Endotoxin, Bioburden, Leachables & Extractables. U.S. CLIA QA QC & Proficiency and Environmental Health and Safety EHS compliance. He is the Founder, Director, CEO of STAT-CAPA Consulting Company, which provides QMS, CMC Quality Management Systems for QA, QC, cGMP, cGLP, CLIA, ISO and other Regulatory requirements.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: This course will provide detailed knowledge and information about the differences in non-cGMP businesses and the requirements to transit to cGMP regulated operations. Achieving cGMP Quality Assurance directed good manufacturing practices is always possible given there is a strong determination and allocation of time, resources and required capitol expenditures. In order to justify this major undertaking it is very important to assess the impact on the business, the present customers and to preferably enter into signed contractual agreements with the larger pharmaceutical customers who express the desire for you to make this change in your business. There should be a clear substantial increase in the business as per those agreements. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why Should you Attend? To gain knowledge and insight on the requirements and changes necessary to effectively transition from non-cGMP Manufacturing and or Analysis Services to FDA 21 CFR 11 Regulated cGMP Operations.
Objectives of the Presentation: The objectives of the presentation are to discuss about topics like: cGMP versus non GMP Market Customer Client Assessments, Instrumentation, Equipment and Facilities Requirements, Required Qualifications IQ OQ PQ, Required Systems and Methods Validations, Common Misconceptions, Difference in Operational Costs, Requirements for Quality Management Systems, Quality Assurance, Quality Monitoring, Ongoing Quality Improvements, Supplier Qualifications, Materials and Systems Tolerances and Specifications. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit? President CEO COO CSO CFO Board of Directors Founders C-Level and Director level Professional Executives in: Business Development, Quality Assurance Professionals
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works? • • • • •
Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Recorded Session - How it works? • • • •
A link will be provided to you upon purchase of the recorded session Please click on the link to access the session Presentation handouts in pdf format will be mailed to you Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com