TRAINING
PQC Consulting Inc. offers variety of training courses that will be structured around each company’s needs. Private one-on-one or customized training classes for small groups are also available.
Responsibilities of Quality Units
Compliance and Quality Functions (Quality Assurance and Quality Control)
Managing CMOs
Quality Assurance Management of contract manufacturing and laboratory sites/External Quality group
Review Batch Production and Control Records (executed Batch Records)
Disposition/ release of products
Quality Assurance audits. How to conduct internal and external (contract sites and raw materials vendor/suppliers) audits
Understanding ICH Q7A and CFR part 210-211
Pre-Approval Inspection (PAI) Preparations
PQC Consulting, Inc. also offers its own series of training seminars held at various exciting locations for the biotech and pharmaceutical industries. Our seminars are taught by experts in their respective fields.
Along with our partner, Compliance Online, we also offer webinars which is available to a worldwide audience.
LEADERSHIP
CONSULTING
Regulatory Filing: Provide clients with necessary support for successful regulatory filing and Pre Approval Inspection (PAI). PQC Consulting Inc. can help clients with:
Data verification and preparations
Pre Approval Inspection (PAI) Preparations
Regulatory filings and PAI preparation at Contract sites
Development reports
Writing and reviewing of Chemistry, Manufacturing and Controls(CMC ) sections of regulatory filing
Non-Conformance/Investigations: PQC Consulting Inc. partners with clients to set-up and implement all CGMP compliance requirements for handling non-conformances (deviation, events, incidents, and OOS) and investigations. Services are structured around client-specific needs. Many elements include:
Developing and Maintaining a Tracking System
Analyzing Trends and Root Causes
Conducting Investigations
Generating Investigation Reports
Reviewing of Documents and Reports
Investigating of Test Failures and Out of Specifications (OOS)
Outsourcing-Managing Contract Sites: PQC Consulting Inc. has developed a comprehensive program for managing and monitoring contract manufacturing sites. The program will assist clients with all requirements, from selecting contract manufacturing sites to ongoing monitoring processes. Major elements of this excellent program consist of:
Site Selection/Site Assessment
Conducting Audits
Generating Quality Agreement
Defining Roles and Responsibilities
Quality Assurance Oversight
Ongoing Monitoring
Managing Ongoing Operations
Change Control/Change Management: A core element to the Change Control Process is the creation of a good tracking and evaluation program. PQC Consulting Inc. can assist clients in planning, evaluating, tracking, and maintaining a robust system to address change control/change management processes. A few topics include:
Developing and Maintaining a Tracking System and Generation of Comprehensive Reports
Analyzing Trends and Root Causes
Establishing Implementation and Post-Implementation
Requirements
Validation: PQC Consulting Inc. can partner with clients to establish an overall policy and approach to validation activities:
Cleaning Validation
Process Validation
Analytical Methods Validation
Comprehensive and high quality validation documentation is vital to achieving validation success. PQC Consulting Inc. can help clients to develop, review, and approve validation documentation, including:
Master Validation Plans
Validation Protocols
Validation Reports
Audits: PQC Consulting Inc. can conduct audits for clients or assist clients with setting up and/or conducting audits. A few areas include:
Start-up of New Facilities
Self Inspections/Internal Audits, Including Manufacturing Process, Testing Laboratories, Warehouse, Documentation Management, and Compliance
External Audits, Including Contract Manufacturing Sites and Vendor/Raw Material Suppliers
Audit/Review, Standard Operating Procedures (SOPs), Analytical Methods, and Specifications
Preparations for FDA and European Audit
Quality Systems: PQC Consulting Inc. can assist clients with meeting FDA (US), EMEA (European Union), and MHLW (JAPAN) requirements in setting, implementing, and monitoring quality systems. Essential quality elements to consider include:
Improving Programs and Creating New Processes to Advance Quality Systems
Developing and Implementing Robust Quality Systems for Clinical and Commercial Products
Non-conformance Investigations and Corrective/Preventative Actions
Change Control Program
Vendor/Supplier Qualification Program
Assessing the Cost of Quality – Technical, Financial, Organizational Concerns – by Researching Issues, Providing Recommendations, and Evaluating Risks
Managing Contract Sites – Selections and Start-up of New Contract Sites/Facilities, Transfer of Processes, Methods as part of Technology Transfer/New Product Introduction (NPI)
Generating Operation/Quality Management Reviews (QMR) and Preparing Formal Presentations for Required Forums
Start-up of New Manufacturing Facilities
Quality Programs for Daily Operation in Compliance with CFR Part 210-211 and ICH Q7A
Writing and Developing Company Policies, Guidelines, and Departmental Standard Operating Procedure
PUBLICATIONS
The following Guides, Checklist, and Templates are available to purchase:
Quality Agreement (QA08-1)
Quality Management Review (QMR08-2)
Roles and Responsibilities of the Quality Units (RRQU08-1)
Audits (A08-1 to A08-5)
Validation Protocols (VP08-1)
Validation Reports (VR08-1)
Investigations (IR08-1)
Out Of Specifications (OOS) (OOS08-1)
Click here to download Publications and Manuals order form
