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Langue du site : Français - English
Réf : 30200
Evènement :CGMP controlled Raw Materials

Date :Jeudi 15 Août 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products

Program

  1. Regulatory Requirements for all Incoming cGMP Controlled Raw Materials:
    1. What does the regulation say about raw materials that are received for cGMP use
  2. Receipt and Storage of cGMP Controlled Raw Materials
    1. Delineation of Raw Materials
      1. Critical
      2. Non-critical
    2. Acceptable Storage of cGMP Controlled Raw Materials
      1. Control of Conditions (Temperature and Humidity Control)
      2. Control of Location (Lock and Key)
      3. Quarantine, Segregation and Labeling Requirements
      4. Testing and Qualification
      5. Approval and Release for use
      6. Disposition and Release for Use Requirements
      7. Dispensing and Traceability (Tracking)
      8. Discarding and Reconciliation
  3. Processing New cGMP Controlled Raw Material Specification
    1. Receiving and Handling of cGMP Controlled Raw Materials
    2. Processing the cGMP Controlled Raw Material Specification
    3. Changing cGMP Controlled Raw Material Specification
    4. Retiring cGMP Controlled Raw Material Specification
  4. Procedure for Raw Material Initial Receipt
    1. When Quality Control Sampling is Required
    2. Processing cGMP Controlled Raw Materials
    3. Assessment and Determination of the Criticality of the cGMP Controlled Raw Materials
    4. Performing the Verification Checks
  5. Testing Requirements for all Incoming cGMP Raw Materials
    1. New and Unqualified cGMP Controlled Raw Materials (Initial Qualification)
    2. Acceptable Testing Programs and Frequency
  6. Test Requirements for Routine and Confirmatory Testing of Qualified cGMP Controlled Raw Materials
    1. Already qualified cGMP Controlled Raw Materials (Subsequent Qualification)
    2. Acceptable Testing Programs and Frequency
  7. Routine and Yearly Confirmatory Testing for Suppliers and Manufacturers of Qualified cGMP Controlled Raw Controlled Materials
    1. Acceptable Testing Programs and Frequency
    2. Review of Supplier Approved Status
    3. Review of Initial Qualification
    4. Review of Quality History
    5. Review of Comparison Criteria
    6. Review of Appropriate Intervals
  8. Evaluation of Suppliers and Manufacturers of cGMP Controlled Raw Materials after Approved Specification Changes
    1. Review of Previous acceptance of affected cGMP controlled raw materials.
    2. Review of the affected change and potential product impact and batch
  9. Disqualification of cGMP Controlled Raw Materials Test Parameters
    1. When can a cGMP Controlled Raw Material Testing test parameters be disqualified.
  10. Requirements for the Comparison Criteria Used in the Confirmatory Yearly Testing
    1. When comparison criteria can be used in lieu of a full qualification.
    2. How to establish and document comparative analysis in lieu of full controlled material testing.
  11. cGMP Controlled Raw Material Confirmatory Testing Process
    1. Outline of the process for completing the yearly controlled material confirmatory testing.
  12. Issuing and Approving cGMP Controlled Raw Materials Specification
    1. How cGMP Controlled Raw Materials are issued and release
  13. Processing Failed cGMP Controlled Raw Materials
    1. How to handle a cGMP Controlled Raw Material with a failed result.
  14. Documentation of cGMP Controlled Raw Materials
    1. Documentation Practices and Required Documentation to Satisfy Qualification
    2. Issuance of Specifications
  15. Investigating OOS Associated with Rejected cGMP Controlled Raw Materials
    1. How to investigate a failed cGMP controlled raw material initial and subsequent qualification testing.
    2. Documentation the OOS Investigation of Rejected cGMP Controlled Raw Materials
    3. What to do with Existing cGMP Controlled Raw Materials in Quarantine

Speakers


Charity Ogunsanya
Director of Quality Control, Pharmabiodevice Consulting LLC

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.

She has a keen working knowledge of the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections.

She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.

 
 

Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

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Précisions

CGMP controlled Raw Materials Pharmacie
cgmp controlled raw materials, labeling requirements, 21 cfr 110.80, fda 483’s, inventory tracking, testing and qualification, cgmp, fda
Professionnels, Quality Control Analysts and Management Senior Management Manufacturing Associates and Management Shipping, Receiving, Warehouse Personnel and Management Raw Material Receipt and Testing Personnel Quality Assurance Analyst and Management Quality Engineering Personnel and Management Supplier Quality and Auditors
10 -- --
English

Divers

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