Project Management Training for Pharmaceutical Regulatory Affairs

Regulatory affairs has expanded over time to include skills and competencies more commonly associated with project management. You must manage projects formally, with a written plan that includes regulatory requirements, design and/or change control, and consideration of all applicable standards, as well as demonstrate 'progress against the plan' according to the US FDA.

You must have a thorough understanding of how to manage each project to ensure that the product developed, manufactured, or distributed meets the agreed upon timeframe, budget, desired quality and regulators' expectations.

ComplianceOnline has engaged elite experts to provide extensive project management knowledge for you and your team through the following training bundle. This bundle is suitable for novice and seasoned regulatory affairs professionals helping them steer their organization in the right direction.

• See what’s covered in the training bundle
• Project Management for FDA-Regulated Companies
• 10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance
• Change Control - Implementation and Management
• Documenting a Risk-Based Quality System - for Compliance and Cost-Savings
• How to Manage Your Vendors in Clinical Research
• Project Management for FDA-Regulated Companies
• This training will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

Areas Covered in the Webinar:

• Meet key requirements of the CGMPs/ISO; Quality Plans
• 'Failing Fast' Formal Lean Project Management
• The Three Most Common Tools - Gantt, CPM, PERT
• Work breakdown Structure, Milestones, Tasks
• Drive Success or Failure Fast; Fast Cycle/Agile Principles
• The Build, Measure, Learn, Re-evaluate Loop
• Example: A Suggested New Product Template
• One Major, But Often Neglected, Use
• 10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance
• This Risk Analysis training will be helped to see how to develop a compliant Hazard Analysis/Risk Management File and Report, as outlined in ISO 14971:2001, a standard recognized by the FDA and rapidly being adopted by industry.

Areas Covered in the Webinar:

Elements of ISO 14971: Narrative, hazard analysis and the Appendices, risk analysis tools and rankings, the Risk Management File and Report;

Locating and using sources of hazards/risks;

Parallel approaches to developing the document;

When to involve teams;

Who to consider for sign-offs/approvals;

How to use the completed document;

Ways to ensure it remains a 'living (and useful) document'.

• Change Control - Implementation and Management
• This training will help in change control implementation and management to ensure that documentation reviewed years later correctly reflects how product was designed, produced, tested, and released years earlier.

Areas Covered in the Webinar:

• CGMP and ISO 13485 requirements
• Involvement in many 483s
• Change control and QSIT
• Major industry problems with Change Control
• SUPAC, Validation, and Technology Transfer Issues
• Preventing negative changes
• Maintain a ’state of control’; Management Review
• Risk Management (per ISO 14971) and Change Control
• When to report to agencies
• Documenting a Risk-Based Quality System - for Compliance and Cost-Savings
• This webinar will help you evaluate your existing Quality Management System (QMS) in light of the changes in the FDA's CGMP/QMS enforcement paradigm. Learn how to document a risk-based QMS at your organization for both compliance and cost savings.

Areas Covered in the Webinar:

The 'targets'

• Avoid complacency from past 'good' U.S. FDA/EU ISO audits
• The basic underlying issues
• Why 'documentation'
• Proactive company system responses - where to shift focus first
• Where to direct scarce resources
• A risk-based phased approach
• Avoid 'entropy' - Prove 'in control'
• Maintain 'the edge'
• How to Manage Your Vendors in Clinical Research
• Learn how to choose the right vendor, onboard and set up, manage vendor performance, manage issues and ensure compliance with current FDA regulations and ICH guidelines and have a smooth-running clinical study.

Areas Covered in the Webinar:

What do the Regulations mean?

Vendor oversight - Where do you start?

• Vendor management as a team approach
• Defining requirements
• Quality insight and input
• Pre-Qualification of a vendor
• Use of Tools and Processes
• Managing vendor performance