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

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

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