GxP Perspectives Calls it a Day

July 23, 2012

GxP Perspectives is Calling it a Day

On 13 February 2009 GxP Perspectives came into existence as the fledgling blog, Carl’s Blog on FDA Stuff. Since then the blog has published 202 additional posts, many by experienced GxP Professionals, and has accumulated 607 email subscribers and 577 members of the GxP Perspectives Linkedin Group. However, putting out a blog takes up a lot of time and energy and I have pretty much run out of things to say. So rather than see the blog sort of fizzle the way of so many internet efforts, I am going to call it a day. This is my last post.

I intend to keep the Linkedin group active as we have some good discussions. I am also keeping the blog up as we get about 1,700 to 2,000 page views a week. There is a lot of good information on the blog. You can see the top eight blog posts for the past week at the top of the sidebar to your right.

I realized that GxP Perspectives‘ days were numbered when there was a front page article in the New York Times about email surveillance by FDA managers of scientists at FDA. I had absolutely nothing to say and, to my credit, I didn’t say it. I would like to direct your attention to FDA Matters by Steve Grossman which has an excellent blog post on the subject. He gives a good, fair account about an issue that we don’t know the full story about. Good for Steve.

Feel free to leave a comment. If you have a question I will try to give an answer or ask someone who can. Best regards and good luck to all of you.

23 July 2012 – Carl Anderson, GxP Perspectives

You can still join the GxP Perspectives Linkedin Group

One additional point: My wife, Cathy J. Tashiro, just had her book come out in paperback. No, it has nothing to do with GxPs or clinical trials, she is a sociologist. Her book is:

Standing on Both Feet: Stories of Older Mixed Race Americans


Three Things That You Should Know About Part 11

June 4, 2012

Part 11

Three Tips on Part 11

What is FDA doing about Part 11? Is the regulation for electronic records and electronic signatures still in force? – The answer is YES – What, if anything, should my company or clinical site be doing about it. Strict compliance can be very expensive- almost as expensive as no compliance at all! Here are three tips on Part 11 compliance from veteran consultants and regular GxP Perspectives contributors, Emma Barsky and Len Grunbaum. I first met Len at the last FDA training course I attended as an FDA field inspector. He is still training FDA and Industry on computerized systems. Given that FDA is focusing more and more on the automated processes and integrity of the data collected using automated means, Part 11 is more important than ever.

Carl Anderson, GxP Perspectives

GUEST COMMENTARY
Three things you need to know about 21 CFR part 11
by Emma Barsky & Len Grunbaum

Fifteen years after becoming effective, 21 CFR part 11 seems to generate as much controversy as it did when it was first implemented. At this point in time, we cannot think of another regulation that sparks as many disagreements with respect to its interpretation and generates as many discussions. Why is that?

Since the inception of the regulation as of August 1997, compliance has been, in our view, analogous to the story of Goldilocks and the Three Bears: compliance in some companies has been too hot (i.e., too restrictive and expensive); compliance in some companies has been too cold (i.e., minimal if any at all); and, compliance in some companies has been just right (i.e., cost-beneficial and based on an effective risk assessment). So, while we do not in any way want to equate compliance with the regulation to a bowl of porridge, we hereby offer three main things that you need to know about 21 CFR part 11 to help you make your compliance just right:

PART 11

THE IMPORTANCE OF VALIDATION

1. You need to know how to assess risks when it comes to 1) developing a validation approach regarding a given system and 2) implementing controls (e.g., audit trails, logical/physical security) to help ensure the trustworthiness and reliability of the records. As indicated in the Scope and Application guidance, the FDA’s “current thinking” on the subject, the agency will expect you to have a justified and documented risk assessment regarding these items. However, in order for the respective strategies and controls to be cost-beneficial in context of the potential of the system to affect product quality and safety, and record integrity, a combination of knowledge of system functionality, regulatory understanding, financial prudence and a healthy dose of common sense are required. Take one of these elements out of the equation and the resulting risk assessment will be neither practical nor useful.

2. You need to know the minimum documentation that must be available to support compliance with 21 CFR part 11. Irrespective of the development model employed (e.g., waterfall, Agile/Scrum), the software delivery model employed (e.g., software-as-a-product, software-as-a-service) or data hosting model employed (e.g., internal data center, outsourced hosting), as applicable, a documentation suite that truly supports compliance should encompass the following:

• User/functional requirements, including 21 CFR part 11 requirements, to describe what the system is supposed to do;

• Technical specifications to define how the system is built and how it works, and which is the critical component in supporting effective system maintenance (e.g., troubleshooting problems, assessing the impact of planned bug fixes and enhancements);

• Development/validation SOPs, and evidence of compliance (e.g., required documentation, required approvals, developer-level and user acceptance testing), to define the process for developing and deploying a system that operates as intended and meets regulatory requirements;

• Traceability between test evidence and all requirements;

• Change control SOP and supporting change request/change control records to ensure that the system continues to operate as expected;

• Training SOP and supporting training records to support staff qualifications regarding system development, maintenance and use;

• IT infrastructure SOPs (e.g., logical/physical security, back-up and recovery, etc.) and supporting records to evidence on-going protection and availability of records.

3. You need to know that, for a given system, the quality of testing and quality of reviews are of paramount importance because they may compensate for ineffective development and/or validation SOPs. In other words, the devil (or in this case the saving angel) is in the details. Therefore, it is important that

• Testing is complete and reflective of true system risks;

• Test evidence is supportive of test results/conclusions and/or does not raise “red flags”;

• Reviews are timely and reasonable (e.g., only a realistic number of detailed test scripts should be reviewed in one day);

• Incident reports are reviewed and approved by appropriate individuals promptly.

If testing practices, testing evidence and/or testing reviews are questionable, they will constitute a serious gap from a risk-based perspective because 1) one may not be able to rely on the given system’s operation, results, etc., and/or 2) data quality and integrity may be viewed as being compromised.

Part 11

Is your Compliance Running Too Hot or Too Cold?

While there are other aspects to 21 CFR part 11 that one should know (e.g., how to determine if 21 CFR part 11 even applies to you and, if not, how to document such a conclusion), the three items discussed above represent those areas where, in our view, compliance tends to be too hot (i.e., potential business risk in that the cost of doing business may be higher than it should be) or too cold (i.e., a potential regulatory risk in that regularity requirements may not be met which, in turn, may result in business risks based on the operational impact of FDA enforcement actions).

Emma Barsky and Len Grunbaum
Partners of The Practical Solutions Group, LLC
609.683.0756
Practical Solutions

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Quantifying Quality for GxP Compliance

April 8, 2012

quantifying quality GxP

Quantifying Quality

GxP professionals understand the need for quality and quality system and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insight on how to quantify quality for the development manufacture, and distribution of health products such as drugs, medical devices, and biologics.

Quantifying Quality

In its simplest form, the definition of “quality” is “how good something is.” But what exactly does this mean for the life science industry, whose frame of reference is defined by regulations which are often vague and which provide little or no guidance regarding how they should be implemented?

In light of this, we would like to offer some ideas regarding how to measure – quantify – how good your “quality” is in tangible and practical terms. We contend that such metrics are useful in order for company management to make sound decisions regarding whether and/or where the quality system (i.e., the operational infrastructure that promotes and facilitates “quality”) requires improvement. The following key indicators are not all-inclusive (nor are the items mutually exclusive), but they provide meaningful ways to assess your “quality”:

• Number of successful external and internal audits as a percentage of the total number of external and internal audits: the higher the percentage of successful external audits (e.g., by existing/potential clients, regulators), especially when you have a large number of them, the better your “quality.” Passing one audit with flying colors is great but passing multiple audits with few minor or no observations is way better. It not only sets a trend regarding “legitimate” quality but it also validates the company’s degree of quality from different perspectives. This scenario allows any company to claim that its quality system has withstood scrutiny from a variety of companies and/or regulatory agencies over a long period of time.

While “looking good” to the outsiders is great, “feeling good” about what is under the covers is even better. Therefore, if thorough internal audits do not find any issues that either directly (critical observation) or indirectly (major observation) impact subject/consumer safety and/or data/product integrity, then “quality” is inherent to the operations.

GxP quality quantify

Measurements for Success

You may wonder how a subjective term like “success” is defined in this context. Fair question. A result of “no audit findings” (e.g., no FDA 483s, no audit observations) is the clearest measure of success. A relative handful of “minor/cosmetic” issues is not perfect but is certainly acceptable in this context. To the extent that the number of observations may be “critical” or “major,” as defined above, the audit will certainly be viewed as less successful or even unsuccessful. One should also remember that it is a common thing in the industry to consider a large number of minor observations as a major issue because this scenario gives an impression of a negative trend, the latter of which is not conducive to having quality operations.

Number of “directed” (i.e., “for cause”) audits as a percentage of total audits: because directed audits are performed to follow up on actual or perceived regulatory compliance problems, the higher the number of “directed” audits, the more questions will be raised about your “quality.” “Directed” audits could be external (i.e., performed by existing clients or regulatory authorities) or internal (i.e., performed by internal quality staff). The higher the number of problems confirmed, the weaker the quality system. Even if these types of audits indicate in general that there are no actual problems, or a minimal number of problems, a large number of such audits should prompt questions regarding why the perception exists that the degree of “quality” is such that an investigation is required.

quality

Number of Investigations

Number of investigations/CAPAs: an investigation is a formal and documented process performed to gather information (e.g., root cause, impact) regarding a specific problem encountered (e.g., a customer complaint, a missing controlled document) and which, depending on the outcome of the investigation, may lead to corrective and preventive actions. An “excessive” number (the definition of which is admittedly subjective in nature) of investigations, even if satisfactorily completed and closed, gives an impression that the underlying cause has never been properly identified and/or corrected.

Number of repeating issues as a percentage of the number of audits performed: repeating issues are symptomatic of a quality system that does not correct or otherwise effectively address problems. While isolated incidents are not necessarily a reflection on the company’s overall quality, incidents that span multiple project teams and/or departments and/or are observed more than once may be indicative of quality-related problems. It is very difficult to convince anyone of the quality of operations when problems that are systemic in nature become evident.

The higher the percentage of audits that contain repeating issues, the more likely that this may be viewed as 1) management indifference, 2) lack of management involvement, 3) inappropriateness of personnel qualifications and/or 4) inability/unwillingness to invest in “quality.”

quantify quality GxP

Lost Business

Number of business opportunities lost due to unsuccessful external audits as a percentage of the number of external audits: audits are sometimes performed as a basis for determining whether a business relationship should be consummated or continued (e.g., you will be chosen as a vendor/supplier, an existing relationship will be sustained) or expanded (e.g., a company will be awarded additional projects). Some life science companies (e.g. pharma, biotech) have to get clearance from the FDA prior to being able to market their product. Support companies (e.g., CROs, contract manufacturers) may have to undergo due diligence inspections to establish/maintain/enhance a business relationship. The higher the percentage of such opportunities lost (e.g., loss of a potential or existing client, project cancelled/not awarded, FDA did not grant an approval) because of poor audit results, as a percentage of external audits performed, the stronger the indication that your “quality” is dangerously weak. This, in turn, has a financial “bottom line” impact on the company: loss of business opportunities can also be translated into wasted R&D cost and/or lost anticipated revenue, both of which become a major risk to the company’s financial health.

In addition to the items listed above, there is another important quantifiable component to “quality,” which is too often being overlooked or not being considered at all. This component is what we define as “the monetary expenditure associated with ‘quality.’” Namely, we are talking about an operationally quantifiable parameter – cost of establishing and maintaining “quality” operations. Most will argue that “quality” is very expensive no matter what. We firmly believe that it does not have to be that way if the underlying causes, which directly and unnecessarily contribute to the extra cost of doing business, are either eliminated or minimized. Here are a few examples to give you a flavor of what can contribute to increased costs when it comes to meeting the regulatory responsibility of instituting and sustaining “quality”:

Regulatory compliance decisions that are not defined in writing and/or are not defensible.

Cumbersome and inflexible procedures that require more resources than necessary to execute them without “procedural deviations.”

Inefficient procedures that require the same activity to be done more than once in order to be in compliance.

Ineffective procedures that do not reach the desired objective of being in compliance after the first execution.

Unclear procedures that result in too many on-going corrections in order to inject “quality” into operations.

Too many procedures that company staff must follow without any value added.

Contradictory procedures that lead to generating Notes-To-File, CAPAs, deviations, investigations, etc. because compliance to one procedure results in non-compliance with one or more other procedures.

GxP Quality

The Costs and Benefits of Quality

The above-listed activities not only translate into the need to spend more time and money in an attempt to have operational quality, but a number of these items translate into further quality-related costs to the company. Examples of the latter include, but are not necessarily limited to, taking the time to respond to observations or even worse yet, an FDA-483 or a Warning Letter. We think the point we are trying to make is clear…

Our bottom line is that you can make both your QA and CFO happy by quantifying “quality” in terms that will be understood and appreciated by both. This means that sound decisions can be made regarding whether and/or where to apply precious company time and resources help ensure that your “quality” is as good as it can be without putting the business out of business.

Emma Barsky and Len Grunbaum
Partners of The Practical Solutions Group, LLC
609.683.0756
Practical Solutions

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In News from FDA: Yet another weight loss danger in Japanese “rapid weight loss” pills. Read the story: foodconsumer.org

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European Qualified Persons & New EU Anti-Falsification Legislation

February 7, 2012

qualified persons anti-falsification legislation

EU Anti-Falsification Legislation

In the European Union an EU certified “Qualified Person” or QP must certify that any batch of medicinal product is in compliance with applicable regulations before it can be released for sale or distribution. Although originally intended for Good Manufacturing Practice, the requirement for QP oversight is now in place for pharmacovigilance and drug products used in clinical trials. The QP is required to have extensive industry experience and the academic credentials, such as pharmacist or chemist, to provide robust, independent oversight of medicinal products.

The EU has enacted new legislation regarding anti-falsification. In this Guest Commentary, Wolfgang Schmitt, Administration Manager European QP Association, discusses the implications of the legislation for Qualified Persons. The falsification of data is a primary concern in the United States as well. Last year FDA introduced a proposed rule for reporting the falsification of data in clinical trials. On both sides of the Atlantic regulators are increasing their anti-falsification enforcement.

Guest Commentary

The Anti-falsification Legislation: Potential Consequences for QPs

The 6th QP Forum of the European Qualified Person Association (EQPA) was held in Budapest, Hungary on 1-2 December 2011 with two parallel pre-conference sessions on 30 November. One Focus was on the new EU anti-falsification legislation and its potential consequences for Qualified Persons.

EU Qualified Person anti-falsification legislation

Tamper Resistant Seals

A first presentation on this topic was given by David Cockburn, Head of Manufacturing and Quality Compliance, European Medicines Agency (EMA) in London, U.K.. David emphasised the need for the directive to “secure integrity and authenticity of products”. The new safety features like serial numbers and/or tamper-evident seals will mainly have an impact on the QPs at parallel distributors as they need to make sure that the authenticity and the integrity is confirmed prior to the removal of original safety features. And this removal of course has to be done under GMP.

Regarding the more stringent rules for the importation of APIs, the QP needs to besatisfied that the supplier qualification procedures ensure verification that suppliers are registered and that the supplier has been audited. This has to be documented in the QP Declaration. After qualifying the supplier it needs to be ensured that the raw materials are actually received from the qualified sources. When it comes to excipients, the QP should at least check that a formal risk assessment has been performed and documented and that the suppliers are qualified accordingly. This should also take into account information in the EU database for excipient suppliers. However an audit is not mandatory but should be preformed for any excipient identified as critical. Regarding the delegated acts, industry and the QPs need to wait for further details. However the QP will need to be satisfied that procedures are in place to comply with the defined conditions for import of APIs e.g.

EU anti-falsification legislation

An Industry Perspective

The aim of the second presentation was to elaborate the industry’s perspective. As Senior Manager Quality & Regulatory Affairs at the European Generic Medicines Association (EGA), Julie Maréchal-Jamil was presenting different aspects. Julie asked the question, how long the overall implementation really will take. Besides the Delegated Acts, other steps need to be taken. It will be interesting to see, how the EC List of Equivalent Countries[1] will be implemented. In the implementation phase of the new Directive, existing guidelines need to be revised and even new ones need to be developed like for example to define risk-assessment principles for excipients or to describe the various confirmations. Julie stressed that currently, there is “no legally defined timeframe for the development and publication of delegated and implementing acts” only a legal timeframe for the entry into force of these legislative acts once they are adopted by the EC.

EGA’s main concerns with the implementation of the Directive on Falsified Medicines are:

1. The so-called “Written Confirmation” of compliance with EU GMP for APIs from non-EU origin. For this process no guidelines are foreseen. Amongst others, EGA sees necessity in having a transition period and a possible risk of heterogeneous supervision of pharmaceutical import and waiver granting in different Member States in the absence of a coordination effort. Here a common central approach will be needed.

2. Process for the establishment of the list of EU GMP “Equivalent Countries.” Here, EGA recommends to leverage existing and operating initiatives like e.g. PIC/S, or MRA and ACAA agreements but also on other similar successful initiatives (Food and Feed) where a staged approach to implementation led to a smooth transition towards a level playing field.

3. Registration of API-related activities for EU-based API manufacturers, importers and distributors (article 52a). For EU multi-sites companies, duplication should be avoided.

4. Pharmaceutical Excipients GMP/GDP. Here, Guidelines should provide a fair reflection of today’s best practices, focusing on cost-effectiveness and existing standards like ISO. Unnecessary over-regulationshould be avoided.

5. Authority/inspectorate funding of the implementation. Details on EGA’s point of view will be published in a White Paper. Both the Forum and the pre-conference workshops were rated very positive by the almost 220 delegates. A survey amongst the delegates resulted in an overall rating of 1.56 (where 1 was the best rating and 6 the worst).

anti-falsification legislation for qualified persons

Budapest

Again very much appreciated was the social event on Thursday evening. Four busses with well selected guides took the QPs for an interesting sightseeing tour through Budapest, the famous capital of Hungary. Followed by a dinner in a traditional restaurant on top of Gellért Hill, the participants were able to continue their discussions and share their experiences with their colleagues in a relaxed atmosphere.

The 2012 QP Forum will be held in Hamburg, Germany on 22 – 23 December with preconference sessions on the 21 November. At the EQPA Advisory Board on 02 December 2011 in Budapest, a structure was defined and first presentations and parallel sessions identified.

Wolfgang Schmitt
Administration Manager
European QP Association, an Interest Group of the ECA Foundation
P.O. Box 10 21 68
69011 Heidelberg
Germany
EMAIL: info@qp-association.eu

U.S. Conference on European GMPs and the role of the QP

There will be a conference in Bethesda, MD on 27-28 June 2012. The conference goals are: “The European Compliance Academy ECA and the European QP Association, recognising this need for further professional knowledge development, intend to support the pharmaceutical industry outside Europe in understanding the European approach and legal framework in this respect. Therefore the QP Association has set up the programme at hand on European GMP requirements and the role of the QP.”

European Compliance Academy

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GxP Perspectives is Thankful

November 24, 2011

GxP Perspectives is Thankful

GxP Perspectives
is Thankful

Today is Thanksgiving in the U.S., a day to be thankful for what we have. It is my favorite holiday. I enjoy eating and I think that saying “thank you” is pretty important. I’m thankful for the readers of GxP Perspectives on the Blog’s third Thanksgiving. I am in particular very thankful for the Guest Commentaries that have been submitted to the Blog. This year they have been great. I am also thankful for the ability to take a break once in a while (which I have been doing). And finally I’m thankful to my family and friends who seem to put up with me. OK- this is a short post but it does have two important announcements, one on the TMF Reference Model from Co-Chairs Lisa Mulcahy and Karren Redding and the other about the GCP CAPA Conference that GxP Perspectives is a media sponsor.

Carl Anderson – GxP Perspectives –
24 November 2011

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TMF Update:

Eighteen months ago, the only guide to the contents of the trial master file (TMF) was ICH-GCP, specifically section 6. Today we have the TMF Reference model, created by a wide variety of experts across pharmaceutical companies, CROs and technical vendors. Version 1.1 was released in February 2011, and has been adopted by many companies – pharmaceutical and CRO alike. The TMF Reference Model has also received positive feedback from the Regulators, with recent comments about what a great reference it is and how much hard work must have gone into it!

Version 1.2 will be released in December – The exciting addition is the adaptation for the contents of Investigator Site Files, facilitating alignment between trial master file contents at the Sponsor or CRO, and Investigator site file contents at the Investigator site. If this part of the model has the same uptake as the main TMF Reference Model, imagine how much easier it will be for the Investigators in terms of standardisation.

Watch this space closely – version 2 will be released early in 2012, to include device studies, process-based metadata and Investigator initiated studies. This is not the limit of the group developments – we are also looking at intra-operability from an electronic perspective, document destruction (a huge area of interest which extends way beyond the TMF) and even quality aspects of the TMF (a new idea put to us just yesterday!)

Karen Redding
Lisa Mulcahy
Co-Chairs of the TMF Reference Model

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2nd Annual Developing CAPAs in the GCP Environment 19-20 January 2012 in Arlington, VA. The keynote speaker is Dr. Leslie Ball, FDA, with a regulatory update on FDA’s Expectations for Clinical CAPAs and Reponses to FDA Warnings. For more information:

GCP CAPA Conference

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eCTD as a Required Format for FDA Submissions

October 29, 2011

eCTD Pyramid

The eCTD Pyramid

The electronic Common Technical Document (eCTD) is due to become a requirement in the immediate future (immediate in the FDA sense of the word). By 2017 FDA will have made the transition from paper to electronic submissions complete. Hopefully, the transition of most types of recordkeeping will also make the transition to electronic format. After the initial investment, this should cut the time and cost of bringing new health products to market. What do you need to know about eCTD? That’s the topic of Kathie Clark’s Guest Commentary.

Five Steps to Become eCTD Ready, by Kathie Clark

In FDA’s PDUFA V Commitment Letter 8-31-2011, the agency announced their intention of issuing draft guidance for required electronic submissions in eCTD format by December 31, 2012, with final guidance no more than 12 months after the close of the public comment period. Twenty-four months after publication of the final guidance, electronic submissions will be required for all new NDA and BLA submissions (originals, supplements and amendments) with a few specified exceptions.

Although many in industry were aware that the agency was preparing legislation to mandate eCTD, others have long been postponing moving to electronic submissions until FDA “pulled the trigger.” The good news is that FDA’s timeline still allows plenty of time for an orderly move to eCTD if plans are put in place now.

Here are some key steps to move to being eCTD-ready:

eCTD

Get Educated on eCTD

1. Get educated. If you are fortunate enough to have one or more team members with real experience in eCTD from a former employer, consider whether they can lead education and process transformation efforts needed to be eCTD-ready. However, be realistic about whether their day jobs allow for these activities. If you need help, consider sending employees for training – or better yet, bring in a knowledgeable consultant to educate your team and help them establish a plan for eCTD readiness. If you have more than a few employees who need training, it’s probably a more cost-effective approach, plus education can be tailored to the context of your submissions, taking into account what types of drugs or biologics you produce, whether generics are involved, which authorities you submit to, whether you will outsource or produce submissions in-house, and many other factors.

2. Understand and act on steps needed to make your source documents eCTD-ready. If you have been submitting paper eCTDs, you may not have been concerned about the quality or granularity of your PDF source documents. For more detail, see my recent article Five key steps for e-submission ready documents to avoid pre-submission rework on the Applied Clinical Trials website. It’s important to understand that you must produce submission-ready documents even if you plan to outsource submission preparation.

eCTD

The Decision to Outsource

3. Decide if you will publish submissions yourself or outsource to a partner. If you plan to outsource, you will need to develop a plan and questionnaire for selecting the most appropriate partner based on competence, cost, specific services offered, service level agreements, and other factors. If you will be publishing in-house, you will need to select, purchase and deploy a publishing tool and ensure that your employees are trained on it and have developed appropriate procedures. Don’t forget submission review – you may want to acquire the validation and review tools used by the agency or agencies you submit to.

4. Develop an overall timeline. Where do the above activities fall? What other factors, such as key submissions, influence the cut-over date that you plan?

5. Understand the logistics of the actual transition. The eCTD Summit blog entry Transitioning from Paper to eCTD at the eCTD Summit provides an excellent overview, with some good follow-up info from FDA correspondence found at the ask-cato blog. It’s best to treat this activity as a formal project, with a project manager, budget, schedule and milestones, and “definition of done” – what does eCTD-ready mean to you and how will you know when you have achieved it?

By planning now, you can achieve compliance in the specified timeframe while also moving to reap the benefits of implementing eCTD.

(eCTD pyramid graphic- Wikipedia)

By Kathie Clark

Kathie’s Website: NextDocs

Ask Cato Blog

The eCTD Summit

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Time is running out to comment on the Draft FDA Guidance on Risk-Based Monitoring!
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Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
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How to comment to FDA: Here is a two-slide powerpoint presentation on how to comment on the draft guidance document courtesy of CDRH BIMO. Thanks!

Location of Monitoring guidance FR

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clinical trials FDA monitoring guidanceThere have been some great comments on the GxP Perspectives LinkedIn group on the Draft FDA Risk-Based Monitoring guidance document and on protocol deviations. 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 on twitter: @GxPPerspectives

And two GCP resources on twitter: @GCPworks and @rebarinter

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On The Blogroll: Rebar Interactive (their twitter account is above) has an excellent blog. They are a digital media company with a focus on the clinical trials industry. Please check out their post on:
Patient Recruitment: Think That You Might Be Wrong,”
if for nothing else than the photo. A great blog post by Rahlyn.
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Please comment with your views on eCTD


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


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