Transitioning from NON-GMP to cGMP manufacturing or CRO Services

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• Transitioning from NON-GMP to cGMP manufacturing
  or CRO Services

GMP Structure
cGMP Structure
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• 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_at_onlinecompliancepanel.com
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• 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_at_onlinecompliancepanel.com
4

• 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_at_onlinecompliancepanel.com
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• 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_at_onlinecompliancepanel.com
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• 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
  QA sessions via chat
• Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• 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.

Recorded Session
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com