Utilizing Techniques for Effective Audits & Assessments
Consider the Following Thoughts on Regulatory Compliance:
Functional Categorization of Suppliers to the Regulated Industry:
Consider the Following Thoughts on Regulatory Compliance:
Understanding and Integrating Global GMP Requirements.
Understanding FDA, EMA, TGA, HPFB, MHRA, and other regulations, guidelines, and requirements.
Techniques for effective audits, inspections, and assessments.
Internal GMP Audits.
Supplier GMP Audits:
Functional Categorization of Suppliers to the Regulated Industry:
Consider the Following Thoughts on Regulatory Compliance:
- Setup
- Agenda
- Execution, Including Opening and Closing Meetings
- Formal Report
- Follow-up, Including Periodic Review of CAPAs Until Closed Out
Functional Categorization of Suppliers to the Regulated Industry:
Functional Categorization of Suppliers to the Regulated Industry:
Functional Categorization of Suppliers to the Regulated Industry:
- Contract Manufacturers (Sterile and Non-sterile.)
- Contract Packagers and Re-packagers
- Contract Analytical Laboratories
- Packaging Components and Labeling Materials
- Metrology Services
- Controlled Transportation Services
- Warehousing Services
- Active Pharmaceutical Ingredients (APIs). (Sterile and Non-sterile.)
- Excipients
- Computerized Systems
Schedules f
- Contract Manufacturers (Sterile and Non-sterile.)
- Contract Packagers and Re-packagers
- Contract Analytical Laboratories
- Packaging Components and Labeling Materials
- Metrology Services
- Controlled Transportation Services
- Warehousing Services
- Active Pharmaceutical Ingredients (APIs). (Sterile and Non-sterile.)
- Excipients
- Computerized Systems
Schedules for, and Frequency of, Internal and Supplier GMP Audits.
Mock Pre-Approval audits/inspections.
Pre-launch audits/inspections.
Clearly understanding and defining the guidelines for GCP audits.
Salient Elements of Clinical Trial Project Management.
Clinical Trial Monitoring.
The practice of Quality and Regulatory Compliance against the backdrop of Murphy’s Law: “Whatever can go wrong will go wrong; it’s only a question of time.”
At Scopus Consulting, LLC, we ensure that our clients do not settle for minimal compliance.
Consider the Following Thoughts on Regulatory Submissions:
Consider the Following Thoughts on Regulatory Submissions:
Functional Categorization of Suppliers to the Regulated Industry:
Would you like to improve your timeliness for the compilation and delivery of the following dossiers?
- United States Drug Master Files (DMFs)
- Active Substance Master Files (ASMFs)
- Electronic Drug Master Files (eDMFs)
- Investigational New Drugs (INDs)
- New Drug Applications (NDAs)
- Biologic License Applications (BLAs)
- Abbreviated New Drug Application
Would you like to improve your timeliness for the compilation and delivery of the following dossiers?
- United States Drug Master Files (DMFs)
- Active Substance Master Files (ASMFs)
- Electronic Drug Master Files (eDMFs)
- Investigational New Drugs (INDs)
- New Drug Applications (NDAs)
- Biologic License Applications (BLAs)
- Abbreviated New Drug Applications (ANDAs)
- Abbreviated New Animal Drug Applications (ANADAs)
- Application for the Certificate of Suitability (CoS)
- ICH-CTD/eCTD Dossier Sections
Learn how to structure each of the listed dossiers to meet the ICH-CTD/eCTD format requirements.
Learn How to Prepare Acceptable Dossiers:
Consider the Following Thoughts on Regulatory Submissions:
Learn How to Prepare Acceptable Dossiers:
- Addendums/Addenda
- Supplements
- Amendments
- Variations
Learn how to compose and structure responses to Deficiency Letters issued by Regulatory Authorities.
At Scopus Consulting, LLC, we assist our clients to shorten the “time to market” and “market integrity” of their products.