Fall GxP Training Opportunities

September 11, 2011

GxP Fall Training

GxP Training Opportunities

Training and continuing education: After the lazy days of summer the seasons change and a host of conferences, workshops, and webinars become available. Finding training that is interesting, timely, and cost-effective isn’t always that easy. We only have so much time for training so picking which places to go is an important decision. I like to actually go someplace and sit in a room with people. When you are self-employed, the interactions that take place at conferences and workshops is invaluable. I recommend to my clients that GxP Professionals should have the opportunity to attend at least one conference/workshop a year. However, it isn’t something you can do every day. Webinars and teleconferences can be a good option when time and money are in short supply. My least favorite option is online training or “read and acknowledge” of SOPs. I think training needs some form of interaction with others. So here are my offerings for this fall:

training GxP

Audits & Risk Management

GxP Audit & Risk Management Congress: 20-21 October 2011, Philadelphia, PA. This conference combines both GMP and GCP tracks to maximize the opportunity for cross training, shared best practices, and networking. Two members of the GxP Perspectives LinkedIn group, Janice Wilson and Adi Lampmann, are among the faculty. The conference is sponsored by ExL Pharma and GxP Perspectives is a media partner.

GxP Audit & Risk Management Brochure

Demystifying the Puzzle: Making the Right Laboratory Informatics Choices for Your Organization: September 29, 2011. Gloria Metrick is speaking at this free webinar sponsored by Expertbriefings.com.
Webinar Information

Contract Pharma 2011 Contracting & Outsourcing Conference: 22-23 September 2011 New Brunswick, NJ. My colleague John Avellanet at Compliance Zen blog will be giving an Overview of FDA’s Process Validation Guidance. Conference Agenda

Pacific Regional Chapter SQA Fall Training 10-11 November at Allergan in Irvine, CA. The training will feature a debate which should be an interesting development in training workshops: Debi Garvin, MS, RQAP-GLP and Paula Parsons: Debate: The role of CAPA in a GLP environment.

PRCSQA Fall Training

Applied Clinical Trials will have a webcast with Free registration on Thursday, September 29, 2011 at 11:00 AM EDT: Understanding the New EU PV Regulations

MAGI’s Clinical Research Conference – 2011 West takes place in Las Vegas, NV 23-36 October. I’ve never attended but have heard good things about this annual conference.

On 16-17 November SoCRA and the FDA present:
FDA Clinical Trial Requirements Regulations, Compliance, and GCP Conference in Philadelphia. This conference has been presented around the country and I keep missing it. It is on a basic level but will have information for everyone involved with clinical trials.

On the Pacific coast, FDA, Center for Drug Evaluation and Research (CDER) is announcing an industry workshop entitled ‘‘CDER Small Business Assistance – Clinical Trials and Electronic Submissions.” This two day event will be held in two California locations consecutively. The first workshop will be held in Los Angeles, CA, on September 26-27, 2011, followed by a second in San Francisco, CA, on September 28-29, 2011.

And in London 2 December 2011:
The MHRA Pharmacovigilance Inspections Symposium
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On The Blogroll: On Biostatistics and Clinical Trials– Finally a blog on biostatistics that I can almost read:) It is written by Dr. Deng, 邓春勤 A Medical Doctor turned into Biostatistician in Clinical Trial and Drug Development Industry.

My Perspective by Kathryn Davis, Clinical Development. In this new blog on WordPress Kathryn Davis discusses relevant issues including social media, GCP, and recruiting minorities in clinical trials.

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clinical trials FDA monitoring guidanceThere have been some great comments on the GxP Perspectives LinkedIn group on the new FDA risk-based monitoring draft guidance document. There is also a new logo for your viewing pleasure. I invite everyone to join the GxP Perspectives LinkedIn Group and join the discussion.

GxP Perspectives LinkedIn Group

GxP Perspectives has returned to twitter: @GxPPerspectives

Follow GxPPerspectives on Twitter
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If you have suggestions for training opportunities, please leave a comment


FDA Inspections: What NOT To Say & How Not To Say It

March 13, 2011

FDA inspections

"It's Not My Job"

FDA Inspections are Always stressful. How should you answer the FDA Investigator’s questions? What should you say or, more importantly, what should you NOT say? Two common answers are to tell the truth and to only answer the question asked. Both are good points. The FDA investigator is conducting a public health inspection so you should want to tell the truth. It also happens to be against the law to lie to a federal official so there are both positive and negative motivations to answer a question truthfully. It is also a good idea to give a brief, factual, and truthful answer to the question you are asked, not a question you think might be asked. And remember to use a complete sentence. Receiving a barrage of monosyllables in an interview is only going to irritate the FDA investigator. The one answer I recommend to never give to an FDA investigator is, “It’s not my job.”

What? Most people who answer, “it’s not my job” are telling the truth! Not only that, it is not a good idea to answer for someone else who actually has that responsibility. However, you have to remember that an FDA investigator has heard that response one hundred times before. People frequently give evasive answers and avoid responsibility when being interviewed by the FDA. It gets very old, very fast.

FDA inspection

"I Know Who Has That Responsibility"

A better approach is to say, “That isn’t my job but I know whose responsibility it is and let me see if she is available.” During an FDA inspection it is important to build trust. If an FDA inspector asks a reasonable question, let’s say, “How do you ship investigational product to clinical sites?” It is in your interest to see that the right person answers the question and that you find the right person in a timely manner.

FDA has begun a program to increase the types of GCP inspections it conducts. There will be more inspections of CROs and clinical trial vendors such as clinical laboratories. In fact, they have already started. That means that many more people will need training on how to participate in an FDA inspection. GxP Perspectives will be having some Guest Commentaries on the subject and try to provide some practical solutions.

FDA Inspevtions

Frontloading Quality:
The Key to Success

The first step in successfully hosting an FDA inspection is to have a quality system in place that monitors the data or product lifecycle. You don’t want to start your quality process after you lock your database! Then, when FDA does show up, you want to give a positive impression. You want to build trust with FDA. Think back to the last time you phoned your utility company or complained about a pothole on your street. When you finally got a live person and they told you, “that’s not my job,” how did you feel? That isn’t how you want FDA to feel either.

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A new service: Please check out the Services page at the top of the Blog to learn more about GxP Services.
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Take the GxP Survey! Only Ten Questions!
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Here are some helpful articles and resources on FDA inspections:

Applied Clinical Trials on Mock FDA Inspections.

Ten Steps for Improving GCP Inspections by Vernette Molloy and my late colleague, Sandy Mackintosh, also in Applied Clinical Trials

FDA Inspection Guides: How the FDA conducts inspections

BioJobBlog: What’s Up With FDA Inspections Anyway?

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SPECIAL UPDATE: 18MAR2011: FDA has released an updated version of the Compliance Program Guidance Manual 7348.810, Sponsors/Contract Research Organizations/Monitors. There are new sections on registration of clinical trials on ClinicalTrials.gov, Financial Disclosure, the Part 11 Scope & Application Guidance Document, and other issues. If you work for a sponsor, a CRO, or are a contract CRA you MUST read this document. Review Section III, Inspectional.

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A new feature from FDAzilla on FDA 483s

Read the Press Release on 483s

On the Blogroll: GxP Perspectives made the list for Best 40 Blogs (and tweets) on the FDA. This comes from FDAZilla. I think it is a pretty good list.

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Follow GxPPerspectives on Twitter

Visit the TMF Page at the Top Right of the Blog! I am trying to assemble resources for those of us concerned with the Trial Master File. I welcome any contributions you might have of interesting articles and resource documents.

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On The Blogroll: Audrey’s Network– a great way to keep up with news from the San Francisco Bay Area Life Sciences Community

Please join GxP Perspectives on LinkedIn at:

GxP Perspectives LinkedIn Group


FDA To Honor Dr. Frances Kelsey

September 2, 2010

FDA honors Dr. Kelsey

President Kennedy Honors Dr. Frances Kelsey for Her Role in Drug Safety

The U.S. FDA is set to honor Dr. Frances Kelsey, a former medical reviewer who helped start the modern era of clinical trials 50 years ago. Dr. Kelsey prevented the approval of thalidomide in the United States because of concerns about peripheral neuropathy and the lack of testing on the drug’s safety. Among the drug’s proposed usages included treating morning sickness during pregnancy. It was unknown at the time that the drug would pass the placental barrier between a pregnant woman and the fetus. In Europe there were thousands of “thalidomide babies” born with terrible birth defects, including phocomelia, that left the children with deformed limbs sometimes resembling a seal type flipper instead of an arm or leg. The tragedy led to the Kefauver-Harris Amendments to the Food Drug and Cosmetic Act and the requirement for “adequate and well controlled trials” along with testing for safety.

FDA Commissioner Dr. Margaret Hamburg announced that FDA would honor Dr. Kelsey’s achievements.

50 years ago a relatively junior medical reviewer, Dr. Frances O. Kelsey said no to an application to market the drug thalidomide. Despite what she called un-relenting pressure from the manufacturer, she remained unconvinced of the drug’s safety especially its potential effects on the unborn.

Dr. Kelsey’s decision has been described as a game changer for the Agency and the country. Her action spared untold numbers of children in the United States from devastating birth defects caused by the drug and spurred the passage of legislation that gave the FDA authorities it needed to better protect the public health; setting it on a course to become the nation’s premier public health agency that it is today.

On Wednesday September 15th at 10:30 AM I will present a new Commissioner’s award, The Dr. France O. Kelsey Award for Excellence and Courage in Protecting the Public Health, to its first recipient, Dr. Kelsey herself. This award will be given on a regular basis by the FDA Commissioner to selected FDA employees.”

Congratulations to Dr. Kelsey. She certainly deserves the honor.

UPDATE: NY Times article on the event

Read Dr. Kelsey’s Bio from Chemistry Explained. It tells how she and her husband were among the first scientists to verify that some drugs that are safe for adults are dangerous to human embryos. Very interesting reading.

Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

++++In news from GxP Perspectives++++

Read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group

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GxP Training Part 2: Regulatory Compliance for FDA Regulated Industry

June 20, 2010

GxP compliance FDA training

What is the Best Method of SOP Training for GxPs?

GLP; GCP; GMP; GxP, just how may good practices do you need to know in the world of regulatory compliance for FDA regulated industry? In part 2 of this Guest Commentary by training specialist Nancie Celini she discusses the pitfalls of “Read and Understood” as a concept for GxP training on standard operating procedures. This was discussed last week at a training workshop at the Drug Infomation Association’s (DIA) Annual Meeting. While I prepare some comments on my favorite sessions I am giving you part 2 of Nancie’s excellent commentary.

Guest Commentary
Part 2:
Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program
June 9, 2010
Nancie E. Celini, GxP Learning Program Lead

In the previous article I discussed the use of the acronym “GxP” as well as regulations, a changing industry landscape and some suggestions for becoming a learning organization. In this article we will look at learning and why having a strategy, leadership and a comprehensive program is so important in our work and to our future success.

Sponsor organizations have traditionally relied upon a “Read and Understood” approach for instructing its workforce on procedural documents (e.g. Policies, SOPs, working instructions). While this may be a reasonable approach for certain procedures, this method can be unreliable. Reading procedures alone, without additional context and details may leave an organization vulnerable. Employees need to fully understand their job role and responsibilities in context as regards the regulations that keep the organization compliant.

regulatory compliance FDA

FDA Requirements for Training and Experience


FDA has (and will) cite companies for deficiencies in their training programs. U.S. regulations can be broad and subject to loose and often incorrect interpretation. The regulations stipulate that personnel must have “training and education and/or experience” to enable them to fulfill their role. In today’s dynamic e-clinical environment where many functions are virtual and rely upon third parties, this phrase takes on new meaning.

GxP learning programs must be robust and comprehensive and should include the following components:
• Introductory Level (GCPs, GMPs and/or GLPs) for new employees

• Policy and provision for outsourced / consulting personnel who perform regulated activities for you

• Yearly refresher GxP courses that don’t just recite regulations but focus on changes to existing regulations as well as emerging guidance and trends of health authorities / regulators (as well as the political context / global issues / economics and externalities)

• A blend of leader-led and on-line courses (e.g. a “hybrid” model)

• Qualified learning professionals / instructors who lead, manage, deliver and sustain the program

Complete training records; current organization charts; descriptions of roles and responsible parties in the chain of authority; current job descriptions and records of training courses completed linked to roles / responsibilities

• Curriculum Vitae (updated as changes occur)

• Organizational Training Policy and SOP that govern the overall GxP program

A GxP learning program should be role-specific regarding organizational job descriptions and collaboration across functions (clinical, regulatory, human resources, training, etc.). This is critical and likely to be where gaps in procedures and training can occur. Personnel need to understand how procedures relate to each other. Often there is no reference from one process to another that creates these gaps that can lead to deficiencies and ultimately, citations.

FDA training GxP

Are There Advantages to a Learning Management System?

Many organizations have invested in a GxP learning program that includes some of these elements but leadership and strategic planning combined with a learning management platform (a.k.a. LMS) can help to streamline content delivery as well as training records management. Efficient programs can be ramped-up very rapidly and when the paper is removed and an LMS is integrated with an electronic document management repository that manages the lifecycle of procedural documents. An LMS can help an organization save time, money and create an exciting and engaging program when combined with a rich assortment of industry courses. Content that is updated annually and delivered through a low-cost hosted, 21 CFR Part 11 validated system is a goal worth striving for. An LMS is no longer a solution for a large organization. The LMS market has stabilized more than in previous years and there are economical solutions for small organizations as well as robust systems that can support large global organizations.

But don’t forget the classroom. Leader-led sessions enhance the read and understood approach especially for procedures and allow professionals to work collaboratively. And the right LMS can manage your leader-led program as well as your on-line content.

As an educator I want to close by giving you some retrospective history about “training” in our industry. At one time training departments were plentiful in this industry with knowledgeable trainers who were committed to their trade. Due to previous economic downturns, the industry started to downsize and cut many training programs. Sadly, it has been hard to come back from these difficult times and we find ourselves in the midst of climbing out of yet another tough economic trough. Considering patent expirations and tough business and scientific challenges we all face, it is often difficult to justify a program that I have described. But the business of training needs to change in our industry as I’ve seen too many deficient programs that have been relegated to an unimportant level in many organizations. Here is something to reflect on from John Dewey;

“Any genuine teaching will result, if successful, in someone’s knowing how to bring about a better condition of things than existed earlier.”

GxP training FDA compliance

GxP Training for Regulatory Compliance

Isn’t it time for our industry to learn collectively how to bring about a better condition? As an industry we all need to remember that our work is focused on how to ease human suffering and the search for new remedies to cure disease and improve human health. How will we all learn to do better without the right tools and insights? This is the challenge we all face as we rebuild and renew our organizations during this time of unprecedented change.

If you are interested in this topic or further discussion about transforming from training to learning in this changing industry, please feel free to reach me through Carl’s blog. I want to say a great big thank you to Carl for providing this space for thoughtful discussion and insight. I hope you have enjoyed these thoughts on GxP education.

Good luck and good learning!

Read Part One of Nancie’s training article

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

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GxP Perspectives LinkedIn Group


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