SOURCE: Enterey, Inc. Life Sciences Consulting

Enterey, Inc. Life Sciences Consulting

May 01, 2012 17:30 ET

Enterey Life Sciences Reveals Pre-Approval Inspection (PAI) Readiness: 5 Essential Questions

Does Your Company Have the Answers?

IRVINE, CA--(Marketwire - May 1, 2012) - Enterey Life Sciences Consulting, a leading provider of life sciences consulting expertise, in conjunction with the Parenteral Drug Association (PDA), is gearing up for the PDA Southern California chapter's 2nd Annual Industry Summit Cruise on May 10th in Newport Beach, CA. Enterey CEO Mike Ferletic will present a thought-provoking seminar on ways to prepare for a regulatory inspection or partner audit, titled "Pre-approval Inspection (PAI) Readiness: A Case Study. Is Your Company Ready?"

This interactive session will present a case study of an Enterey client who recently conducted a PAI program, and will feature multimedia input from former FDA Investigator, Analyst and Compliance Officer, Mark Tucker, PhD, who will speak to the "hot topics" in PAI as well as input from members of the client's Quality Assurance organization who were responsible for the inspection's success.

The FDA's Compliance Program Guidance Manual explains that PAI is performed to assure the agency that a manufacturer submitting a drug application is capable of manufacturing a drug they way they say they're going to, and that the data submitted in the application are accurate. Anything that erodes the FDA's confidence can halt the approval process.

According to Brian Hagen, Managing Director at the Decision Empowerment Institute, a leader in the field of risk and decision management, "A delayed approval translates into delayed sales or even possibly lost sales, depending on the competitive situation, and PAI readiness is like an insurance clause aimed at mitigating the risk of an issue arising during an inspection that could cause a delay."

Being proactive is a necessary part of PAI readiness, and risk management is a tool that allows pharmaceutical and biotech companies anticipate any issues that could potentially impact a product submission and delay time to market. An effective risk-management plan is tied to decision making and will help a company answer the 5 essential risk-management questions:

1. What are the risks associated with your product launch?
2. Which risks potentially erode the most value if not pursued?
3. Which risks, if pursued with risk mitigation actions, protect the most value?
4. Which risks should our company pursue?
5. What is the residual risk liability after mitigation?

Answering these questions and being prepared for an inspection is an integral part of a successful audit or approval. "One of the most important things to do when preparing for an inspection is to organize and plan. Anticipate the questions that will be asked, prepare the people most likely to speak to investigators, know where all the necessary documentation is located, and ensure that you can retrieve it in a timely manner," stresses Enterey CEO Mike Ferletic.

Enterey's dynamic seminar will help participants answer these and other pressing PAI questions with tactics like gap assessments, mock audits, and war room logistics. The presentation will be followed by an interactive Q&A session, and participants can tweet their PAI questions to the hashtag #InspectionQs or @Enterey for inclusion in the discussion.

With any questions about the PDA event, contact Enterey at (800) 691-2349. For more information on Enterey, visit:

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