FDA Compliance Boot Camp 2016

Imagine getting inside the head of a working FDA inspector …
receiving the same training the inspector gets …
knowing which problems face the most scrutiny …
all before your next inspection.

Here’s how.

Are you confident you’ll sail through your next inspection? You can be when you have the same training the FDA gives its own inspectors.

Know what to expect when the next inspector walks through your door — from what the agency trains its investigators to look for … to which problems face the most scrutiny, including how FDA expects you to manage your computerized systems and electronic records.

You’ll even discover which of your systems will be first-up for inspection. And you’ll learn what’s behind FDA’s new add-on “surveillance inspections” for Part 11 and how the European Union’s new Annex 11 affects your operations, no matter where they are.

Former FDA Investigators Ready to Give You “Insider Advice”

Why risk a single noncompliance penalty? When you attend FDA Compliance Boot Camp 2016 you can feel secure in knowing your next inspection will be a complete success … And it takes less than a week.

Experience a simulated inspection, pick up effective self-auditing techniques and so much more.

Save $695 Now: When You Choose a Multiple Course Track

Choose any one course or a combination of courses (see the schedule) to suit your needs and fit your schedule. Following is a list of the courses and learning objectives of each.

Course #1 — FDA Auditing of Computerized Systems and Part 11/Annex 11
(24 Course Hours)

The FDA is facing a looming crisis of public confidence in two areas directly impacted by computer systems validation — data integrity, especially in clinical and manufacturing environments, supplier quality assurance and audit trails and change control in virtual computing environments.

Enroll your team in the FDA Compliance Boot Camp to ensure your company and its contractors and suppliers aren’t in the cross hairs of the FDA’s stepped-up enforcement in these areas.

Simulated Inspections of Computerized System Development and Maintenance

• YOU BE THE AUDITOR: Learn how to prepare for the FDA inspector – using a simulated inspection with real-world scenarios, SOPs, and personnel responsibilities
• Participate in three hands-on Mock FDA Audits:
  • Off-the-shelf but highly configurable system used for complaint management, adverse event reporting, and other quality management functions
  • Vendor-hosted Learning Management System (LMS) using cloud-based technologies
  • Hybrid in-house developed/off-the-shelf Manufacturing Execution System (MES) with complex network configurations plus change control and data monitoring challenges

You’ll learn:

• Which computer systems need to be Part 11 compliant
• When system validation is required
• What compliance gaps FDA is finding from its “tag-along” Part 11 audits
• Can you validate “cloud” systems or vendor-hosted networks?
• What in the world are “predicate rules” and why you must know them
• Why lots of compliance dollars and resources are wasted on ineffective or inadequate validation
• How to identify, document and report computerized system validation deviations
• Top validation errors cited in FDA enforcement actions
• Proactive steps to avoid CSV and Part 11 Form 483s and warning letters
• Proven techniques for developing compliant software
• Key principles of computerized system validation
• Change control and configuration management
• Ways to work with audit trails and protect data access and transfer
• Evaluation of software vendor compliance claims
• How to prepare for the FDA inspector using a simulated inspection with real-world scenarios
• Five critical pillars required for effective CSV
• Current status of Part 11 — revisions, rewrite or abandonment?
• How Part 11 compares with the EU’s new Annex 11
• Why data integrity is critical with or without Part 11
• Keys to maintaining your systems in a validated state

Course #2 — Quality Risk Management for FDA/ISO/ICH Compliance: Agency Expectations, Global Standards and Tools for Success (12 Course Hours)

• Learn how to identify, assess, and mitigate GxP risks while meeting FDA rules
• Select and apply the optimum tools for risk analysis and management
• Integrate risk assessment throughout your Quality Management System, ensuring conformance with ISO and other international standards

Get practical, interactive classroom training from former FDA investigators and expert advisors, including Janis Olson, noted risk management authority.

Risk management is the bedrock of FDA regulation in the 21st century, especially for quality systems and GxP compliance.

In today’s global economy, you also must keep up with the increasing number of international standardsfor assessing and controlling risks. If you ignore the growing demand for product risk management — throughout your product’s entire lifecycle, from cradle to grave — you’re endangering your company’s bottom-line and public reputation.

In just a 12 hours, you’ll have risk management “de-mystified” by understanding every-day terms, real-world situations, and concepts you can use right away.

Ask 10 companies how they define risk, and you’re likely get 10 different answers. How can you and your team master something as elusive but vital as risk management?

Begin by attending this 12-hour training class and learn FDA’s approach to assessing and managing risk. You’ll study tools and methodologies used by regulated companies around the world.

With that foundation, you’ll also examine how FDA’s approach compares with risk management concepts addressed in the latest ISO standards and in ICH’s Q9 Quality Risk Management guidance (which has been adopted by FDA).

You’ll also study tools and methodologies used by FDA-regulated companies around the world. You’ll get hands-on experience using such tools as Fishbone and Ishikawa Diagrams; Failure Mode and Effects Analysis (FMEA), and Hazard Analysis and Critical Control Points (HACCP). You’ll work with process maps, construct Cause-and-Effect Matrices, and develop tables for evaluating Severity-Likelihood of Occurrence-Detection and residual risks.

You’ll learn:

• FDA’s expectations for managing people, product and process risks
• The language of risk — key concepts and definitions of risk management used by FDA and international bodies
• The regulatory requirements for risk management
• Proven tools for risk assessment, management and hazard control (with hands-on practice)
• How to better integrate risk management with your quality system
• The inter-relationship of ISO 14971, ISO 9001:2015, ICH Q9, and FDA’s GxP rules
• What’s ahead — and why you must develop a mindset to continuously evaluate risk

Enroll your team in Quality Risk Management for FDA/ISO/ICH Compliance.

Course #3 — The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management (12 Course Hours)

If your current CAPA system is disorganized, poorly documented, or not supported by thorough failure investigations, you’re waving a red-flag to FDA inspectors and third-party auditors. Get your quality program back on track by building a robust CAPA system that meets FDA’s latest expectations.

The popular The CAPA Confidence Clinic: FDA Rules for CAPA Systems, Failure Investigations and Complaint Management 1 ½-day course offers instruction on the identification of corrections, corrective actions and preventive actions along with terms that are used to describe nonconformities and CAPA data sources.

Learn how an effective CAPA system can reduce your manufacturing costs, minimize product recalls, and ensure product safety and effectiveness. Discover the elements of a compliant CAPA system, how to get to the root cause of a system failure, and more. You’ll learn:

• The FDA’s requirements for CAPA systems
• Why CAPA systems continue to be at the top of the FDA’s enforcement list
• Definitions of a correction, corrective action and preventive action — and why the difference matters
• 32 important and often overlooked sources of CAPA data
• Recommended flow charts for CAPA data collection and closure
• Key elements of compliant CAPA systems
• Picking the right CAPA tracking tools
• FDA guidance for failure investigations and root cause analyses
• How to conduct a proper failure investigation to its root cause
• FDA’s trending rules — and how Quality Data Trending helps you better manage product risk
• Lessons learned from recent FDA 483s and warning letters

In addition, throughout the courses offered in the Boot Camp, you’ll discover …

• What it’s like to undergo an actual FDA inspection. Compliance Boot Camp’s simulated inspection exercise is as close to the real thing as you’re likely to get — until the day the investigators actually visit your facility
• What FDA investigators are trained to look for … which systems they inspect first … which problems get the most scrutiny
• Self-auditing techniques to use before the investigators call

 

Receive the ValidationVault™ Resource CD — Free with your Boot Camp attendance

A $295 value, the Resource CD gives you desktop access to a treasure-trove of FDA laws, regulations and guidances, inspection protocols, warning letters, and international guidelines.

The CD has been designed by the Boot Camp instructors specifically for those involved in computerized systems validation, quality management, software development, or electronic records/signatures compliance. Included in the ValidationVault™ Resource CD are the latest versions of the FDA’s Investigations Operation Manual, relevant Title 21 CFR regulations, a complete library of FDA guidance documents related to validation and Part 11, key ICH guidelines and much more.

Register today and reserve your free copy of the ValidationVault™ Resource CD.