cGMP Controlled Raw Materials

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cGMP Controlled Raw Materials
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Instructor Profile

• Charity Ogunsanya, is the CEO and founder
  of Pharmabiodevice Consulting LLC. Ms. Ogunsanya
  has over 23 years of extensive practical and
  management experience in various Fortune 100
  pharmaceutical, biotechnology, biologics, cell
  therapy, diagnostics, research and development,
  radio-pharmaceutical, Contract Manufacturing
  Organization (CMO) and medical device/IVD
  companies. She has been a much sought after SME
  to assume key roles specifically related to
  remediation and difficult quality and compliance
  related deficiencies associated with FDA's
  Consent Decree, FDA's Warning Letters and other
  regulatory bodies' inspectional findings. Her
  remediation work has constantly resulted in
  several successful national and international
  regulatory bodies' inspections, re-inspections
  and new product approvals. Her technical
  expertise covers and goes beyond interpretation,
  administration and set up of quality assurance,
  quality/compliance, quality engineering, aseptic
  processing, contamination control, quality
  control, microbiology, sterility assurance,
  stability, vaccine development, new product
  design, product release testing and medical
  device sterilization (ethylene oxide (EtO),
  gamma, radiation, VHP sterilization) systems and
  operations for compliance to various
  regulations. 

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Why Should you Attend

• CGMP raw materials are the
  most critical ingredient in product
  manufacturing hence they must be controlled as
  stipulated in 21 CFR 110.80 Processes and
  Controls as well as applicable FDA regulations.
  Some drug product manufacturers have received FDA
  483's and lost several batches of product due to
  lack of a defined raw material processing that
  showed acceptability through qualification tests,
  traceability, consistency and control of the
  incoming raw materials. Raw material control is
  therefore a very critical part that ensures drug
  product quality, purity and potency.Drug
  product manufacturers must have a clear
  understanding in preventing loss of expensively
  manufactured drug products because of the use of
  an adulterated raw material through a defined
  procedure that clearly shows how raw materials
  are received, stored, labeled, quarantined,
  tested, qualified, tracked, used, and discarded
  at the end of expiry. This webinar will provide
  such guidance as to the process of ensuring that
  all the steps are followed to avoid producing an
  adulterated product as defined by the 21 CFR
  110.80 Processes and Controls.

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Who can Benefit

• Quality Control Analyst Personnel and Management
• Senior Management
• Manufacturing Associates Personnel and Management
• Facility and Utility Personnel and Management
• Quality Assurance Analyst Personnel and
  Management
• Vendors and Suppliers of Pharmaceutical Water
  Systems and Peripherals
• Regulatory Affairs and Personnel Management
• Shipping and Receiving Personnel and Management
• Materials Handling Personnel and Management
• Supplier Quality Personnel and Management
• Site Director Operations Director Others

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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 formate 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
• Please let us know your thoughts and views at the
  end of webinar, your valuable feedback will help
  us improve
• Get certification of attendance.

• 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 formate will be
  mailed to you
• Get certification of attendance.

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About OnlineCompliancePanel

• Online Compliance Panel creates and
  delivers comprehensive industry relevant training
  sessions. These sessions are simple, interactive
  and cost effective. We are a predominantly web
  based information exchange forum. Live
  interactions on compliance training make the
  process holistic and effective. Online Compliance
  Panel largely emphasizes in offering regulatory
  compliance training to compliance professionals
  on varied topics. These primarily include risk
  management, quality management, corporate
  compliance and other regulatory compliances. Some
  of our primary areas of focus include advancement
  and updates in regulatory compliance, best
  practices and market trends.
• For the more information about the webinar
  kindly visit the link given
• http//bit.ly/contractmgnt

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