ComplianceOnline

FREE! Pack of 7 Interesting Webinar Recordings for the Pharmaceutical Industry

Product ID: 705568

recorded version

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Read Frequently Asked Questions

All Modules:

Module 1: GLP or GMP: A Comparison in Terms and Application for Drugs and Biologics
Module 2: Drug Master Files (DMF's) - Understanding and Meeting Your Regulatory and Processing Responsibilities
Module 3: Drug Safety Assessment and Risk Minimization in the Development Period
Module 4: How to transfer QC procedures for commercial products in pharma industry - ICH and USP guidelines
Module 5: DEA, Your Registration and How to Lose It
Module 6: Water System Investigation "How-To's" and Example Case Studies
Module 7: Quality Risk Management Overview for Pharma and Biopharma, ICH Q9/ISO 14971

Module 1 : GLP or GMP: A Comparison in Terms and Application for Drugs and Biologics

Areas Covered in the Webinar:

  • Nomenclature
  • The birth, history and evolution of the terms GLP and GMP
  • How the GLPs and GMPs came to be an their evolution.
  • The major sections of the GLP and GMP regulations: similarities and differences
  • A comparison of the two
  • Avoiding confusion
  • “Flipping on” the GLP or GMP compliance switch: how to do it – or is it possible?

Module 2 : Drug Master Files (DMF's) - Understanding and Meeting Your Regulatory and Processing Responsibilities

Areas Covered in the Webinar:

  • Introduction.
  • Definitions.
  • Types of Drug Master Files.
  • Submissions to Drug Master Fines.
  • Drug Master File Contents.
  • Format, Assembly and Delivery.
  • Authorization ro Refer to a DMF.
  • Processing and Reviewing Policies.
  • DMF Holder Obligations.
  • Transfer of Ownership.
  • Closure of a DMF.

Module 3 : Drug Safety Assessment and Risk Minimization in the Development Period

Areas Covered in the Webinar:

  • Risk conceptualization.
  • Goals of project risk management.
  • Risk management planning & safety review teams.
  • Intellectual property.
  • Pharmacovigilance planning in product risk management.
  • Unexpected study results: efficacy, dosage, adverse events & toxicology.
  • Data analysis, interpretation and presentation.
  • Essentials of Data Monitoring Committees.
  • Drug disposal and environmental impact.
  • Labeling as a hallmark of risk management efforts.
  • Post-marketing risk.

Module 4 : How to Transfer Non-Compendial and Developed QC Procedures - ICH and USP Guidelines

Areas Covered in the Webinar:

  • ICH guidelines for validation.
  • USP guidelines for validation and verification.
  • Applications of the ICH guidelines for method transfer.
  • Debated topics and approaches.
  • Complex procedures.
  • Establishing boundaries.

Module 5 : DEA, Your Registration and How to Lose It

Areas Covered in the Webinar:

  • DEA OFFICE OF DIVERSION CONTROL – This section will familiarize you with the authority given to the Diversion Group when enforcing the laws and regulations pertaining to controlled substances and regulated chemicals.
  • DEA REQUIRED RECORDS – This section covers the requirement differences between the DEA Field Offices and their Headquarter requirements.
  • DUE DILIGENCE – This section provides some suggestions on improving the regulatory compliance of a firm handling Schedules II through V controlled substances and regulated chemical products. It also covers the registrant’s responsibilities to assure that customers are compliant with DEA regulations.
  • DEA "KNOW YOUR CUSTOMER POLICY" – This section provides a better understanding of what DEA requires from registrants in order to maintain an effective suspicious ordering process and steps for compliance with regulations.
  • DEA RECORDKEEPING REQUIREMENTS – This section covers the required records to be maintained in order to comply with DEA regulations. Records include receiving/shipping order forms and invoices, inventories, ARCOS, Quotas, drug destructions, and theft/loss reports.
  • CUSTOMER FILES RECORDS – This section provides suggestions on what information should be in a Customer’s File in order to maintain the necessary documentation especially for a customer whose orders have been identified as an Order of Interest or a Suspicious Order.

Module 6 : Water System Investigation "How-To's" and Example Case Studies

Areas Covered in the Webinar:

  • Gathering and using existing information/opinions
  • Investigation approach: what stones to turn over
  • Discovering a root cause and mitigation strategy
  • Obstacles to remediation
  • Water system contamination case studies
    • The Beige Puddle
    • “TNTC”
    • High TOC
    • The Sloppy Lab
    • Flanged PolyPro System
    • The Stealthy Dead Leg
  • Parting kernels of water system wisdom

Module 7 : Quality Risk Management Overview for Pharma and Biopharma, ICH Q9/ISO 14971

Areas Covered in the Webinar:

  • Understanding Risk
  • Application of ICH Q9
  • Definitions and Concepts
  • Risk Assessment
  • Risk Control
  • Risk Communication
  • Risk Review
  • Example of Risk Management Methods and Tools
Follow us :
FDA's New Import Program for 2018 - Strict Precision
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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