Pharma Quality Advisor - One-Year Charter Membership

Introducing Pharma Quality Advisor

Complete, Practical "How-to" Help to Perform Your Job
as a Pharma Quality Manager More Effectively and Efficiently

  • Quickly and Easily Comply with the Latest FDA and EMEA Regulations
  • Implement and Manage More Effective Risk Management Policies and Practices
  • Prepare for and Survive Regulatory Audits and Inspections
  • Manage Your Quality Systems and Operations More Efficiently and Effectively
  • Implement and Manage More Effective CAPA
  • Plus, Stay Up-to-Date on the Latest News and New Developments in Pharma Quality Management

Here's What You
Get When You Join
Pharma Quality Advisor:

  1. One Year of PQA Weekly Updates covering the latest CGMP news and regulatory developments, including enforcement updates, new law alerts, and notices on new PQ resources available to members online
  2. One year of full access to including articles, videos, special reports, and many other practical tools to help you comply with the latest FDA and EMEA regulations and manage your quality systems more efficiently and effectively
  3. Webinar and Conference Sessions on critical pharma quality topics to keep you on the cutting-edge of the latest pharma quality management techniques and new developments
  4. Member Discounts on valuable products and services for pharma quality managers and other PQ professionals
  5. PLUS, You Get Our NO-RISK GUARANTEE: If you are not completely satisfied with Pharma Quality Advisor, simply cancel and get a full refund, no questions asked!

More Info?

PQA Advisory Board

Published by FDAnews, Pharma Quality Advisor offers content that has been shaped by the insider knowledge of a strong advisory board, including:

  • William Reiss, Senior Manager Supplier Quality Agreements & Global Sample Retain at Celgene

  • Patrick D. Stone, President/Lead Consultant, TradeStone QA, LLC

  • David Charapp, Partner at Duane Morris LLP

  • Philip Crooker, Current Director, Global Regulatory strategy - CMC (US) at Shire Pharmaceuticals

  • Nikki Willett, Life Sciences Global Team Lead Quality & Compliance Practice at Accenture

  • Steven Sharf, Founder and President of GMP Concepts

  • Alan Minsk, Partner and Practice Leader of the Food and Drug Practice

  • John Avellanet, Managing Director & Principal, Cerulean Associates

  • Maxine K. Fritz, Executive Vice President of the Pharmaceuticals and Biologics Practice at Becker & Associates Consulting, Inc.

  • Gabrielle Cosel, Project Manager Drug Safety Project, Pew Health Group

  • Sara Dyson, Manager of Loss Control Services, Medmarc

More Info?

Special Reports You Can Access on Pharma Quality Advisor

  • Change Control: Best Practices for FDA-Compliant Drug and Biologic Manufacturers
  • Mastering Batch Record Review
  • Pharmaceutical Quality Systems: A Guide to ICH Q10 Compliance
  • The 7 Steps of CAPA Compliance
  • Root Cause Analysis for
  • Drug-makers--Six Elements of
  • Successful Investigations
  • FDA Drug Enforcement: An Analysis of Warning Letter Trends
  • Responding to FDA 483: Strategies for Successfully Obtaining Closeout
  • Step-by-step Guide to Managing Contract Manufacturers
  • Managing Supply Chain Risks: Meeting FDA Expectations
  • Supplier Qualification: Developing Risk Assessments and Audit Programs That Work
  • Crafting Pharma Supplier Quality Agreements

Sample Tools You Can Access on Pharma Quality Advisor

  • Process Maps
  • Root Cause Analysis Investigation Checklists and Diagrams
  • Sample Key Quality Measures Matrix
  • Sample Supplier Quality Agreements
  • Sample 483s and Effective Responses
  • Sample Quality SOPs

More Info?

Pharma Quality Advisor is a publication of FDAnews:

300 N. Washington St.
Suite 201
Falls Church, VA 22046

Toll free: (888) 838-5578 (USA)
Telephone: +1 (703) 538-7600
Fax: (703) 538-7676

Pharma Quality Advisor is the first and only online resource designed to provide pharma quality managers with complete, practical, "how-to" help to do their jobs more efficiently and effectively.

Plus, it gives you the "plain-language" help you need to comply with the latest FDA and EMA regulations that affect pharma quality systems.

Pharma Quality Advisor was designed for and by pharma quality professionals. You get cutting-edge help in the 6 areas that are critical to implementing and managing more effective pharma quality systems in today's tighter cost and regulatory environment.

Here's just a sample of the help you get:

1. Managing Effective and Compliant Pharma Quality Systems

It gives you proven techniques and practical guidance to design, implement, and manage an effective pharmaceutical quality system (PQS) that complies with CGMP, ICH Q10, and other current regulatory requirements and recommendations. For example, you'll find out:

  • How to design and implement a quality system that builds in quality from the development phase and throughout a product's life cycle
  • How to tailor your quality system to fit your specific scope of operations, complexity of process, and resource parameters
  • How to establish meaningful quality system objectives
    and monitor your performance vs those objectives
  • How to identify and track key quality system performance indicators and develop appropriate assessment schedules
  • How to develop effective process maps
  • Plus, you get proven strategies to ensure management buy-in to your quality programs and objectives

2. Implementing Effectiive Risk Management Practices

Pharma Quality Advisor gives you the practical "how-to" help you need to easily and efficiently integrate risk management practices into your quality systems. You'll find out how to meet the risk requirements of the FDA's current good manufacturing practice (CGMP) regulations, and how to lower the risk of costly manufacturing delays and problems. For example, you'll discover:

  • The components of effective risk management for pharma quality systems and how to closely integrate risk management and quality systems to reduce manufacturing and regulatory risk
  • How to use risk management techniques to establish clear specifications and process parameters for the manufacturing process … and to mitigate potential risk when changing a process or specification
  • How to make sure your risk management plan satisfies current legal and regulatory requirements
  • How to use risk management techniques to determine what level of monitoring is required for each quality process or outcome
  • How and when to update your risk management plan or policies

3. Managing Corrective and Preventative Actions (CAPA)

Corrective and Preventive Actions (CAPA) systems are at the core of an effective quality system … and a pharma quality manager's day-to-day responsibilities. CAPA are also a constant source of findings during inspections, so it is absolutely critical to handle your CAPA correctly and comply with current regulations and accepted practices. You'll find out:

  • The steps required to implement a CAPA that is both systematic and measurable
  • Why and how to incorporate CAPA methodology into the initial produce design and development process
  • How to conduct a root-cause analysis that clearly identifies the cause of a discrepancy or deviation
  • How to use your root-cause analysis to accurately identify appropriate and effective corrective and preventative actions
  • What data and metrics to track to ensure CAPA implementation and accountability throughout your organization
  • The major reasons CAPA systems fail and how to sidestep common CAPA pitfalls and problems
  • How to handle CAPA following up and recordkeeping to clearly establish due diligence to the FDA

4. Preparing for and Surviving FDA Inspections

Every pharma quality manager must be constantly ready to handle an inspection by the FDA or other regulatory agency. Pharma Quality Advisor gives you the step-by-step help you need to prepare for an inspection … and handle virtually every aspect of the inspection with minimum time, trouble and potential legal liability. For example you find out:

  • How to prepare the your facility for an FDA inspection … what steps you should take as the quality manager … what other staff and managers should do to prepare
  • Proven dos and don'ts for managing ongoing inspections and dealing with FDA and the regulatory inspectors during the investigation
  • What the FDA looks for when conducting an OOS investigation … typical FDA investigation policies and procedures … common investigation tactics and how to be prepared to handle unique problems and situations
  • What to do and say when you don't know the answer to FDA questions ... or when you are not sure of the answer
  • How to respond to inspectional findings to head off further enforcement actions by the FDA

5. Managing Outsourced Suppliers and Contractors

Managing suppliers is an increasingly complex challenge for the quality manager as pharma companies increasingly outsource to third-party vendors. Pharma Quality Advisor gives practical help to manage vendor quality ... and protect your organization against growing legal and business risk. You'll find out:

  • What you need to know and do about legal responsibility for the control of outsourced activities and quality of purchased materials
  • What you need to know about ICH Q9 and IHC Q10 … key steps to take to demonstrate compliance with both regulations and recommendations
  • How to create quality agreements that provide your organization with maximum legal protection
  • Key techniques for managing and monitoring outside suppliers and vendors to ensure adherence to quality guidelines
  • What you should do to audit and qualify vendor facilities prior to outsourcing … and what oversight steps you should take throughout the relationship to protect product quality and minimize liability
  • Proven techniques to help verify that the quality systems of your suppliers can adequately assure product quality

6. Stay Up-to-Date on FDA Enforcement Trends

The FDA has stepped-up enforcement efforts and programs over the past couple years ... including stricter settlement terms, and tougher penalties. To help you avoid costly FDA fines and penalties and legal actions, Pharma Quality Advisor provides in-depth reporting of ongoing enforcement actions, as well as broader analysis of FDA inspection and enforcement trends. For example:

  • It keeps you up-to-date on the latest FDA enforcement trends, priorities, and guidelines ... clearly details what-to-do and how-to-do-it to handle new FDA regulatory and procedural changes ... analyzes how enforcement actions and trends affect your manufacturing and quality systems
  • It alerts you to recent FDA actions under the tough Park Doctrine that can hold CEOs personally accountable for manufacturing problems ... explains how a CEO can now be prosecuted for a misdemeanor or felony even if there is no proof that the CEO had any knowledge of participation in the offense
  • It explains the tougher new FDA position on the responsibilities and obligations of the quality control unit ... reveals why is now more critical than ever to make sure all procedures are in writing ... and that your staff is correctly following all procedures
  • It keeps you up-to-date on FDA inspection actions ... alerts you to inspection "hot topics" ... analyzes recent decisions resulting from inspections ... alerts you to and "heightened activity" and "unusual tends" in FDA enforcement
  • It alerts you to critical FDA Form-483 observations, FDA warning letters, and product recalls ... gives practical guidance to help you avoid common enforcement pitfalls

And that's just a sample of the help you get from Pharma Quality Advisor, the first and only professional resource designed to provide you — pharma quality manager — with the complete, practical "how-to" help you need to do your job more efficiently and effectively and comply with the latest regulations.

Remember, there is absolutely no risk on your part. If not completely satisfied, just cancel for a full refund, no questions asked.

Join Pharma Quality Advisor TODAY.


Dan Landrigan
FDAnews/Pharma Quality Advisor

P.S. Join Pharma Quality Advisor NOW as a Charter Member and SAVE $200 off the regular price of $1,057. This is a limited time offer, so act now.