Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp

Q: I have just been promoted to a new position in the quality organization at my company and will now be responsible for batch record release. I am a little nervous about this responsibility. Can you give me some tips for reviewing and releasing batch records? 


	
	A: This is a great question. Batch record review and release is an important responsibility in any company and it should not be taken lightly. The best way to visualize a ‘batch’ record is to think of it as a series of photographs that, if put together in the proper sequence and with the correct background, tell a story about the quality and suitability of the product. 

	The first picture in this story begins with the incoming raw materials that include the active ingredient(s), excipients, primary packaging, and labeling. Each one of these items should be properly received, sampled, and put into quarantine until the incoming quality group establishes their suitability for use. This includes testing of the water that might be used in manufacturing the product. The background of this picture would be making sure the laboratory equipment was properly calibrated, the methods validated, and the analysts properly trained. Once the materials are deemed suitable, they may be released to the manufacturing line for formulating and processing. The foreground in this picture should be the results from the laboratory testing, the inventory control procedures, and the certificate of analysis from the supplier(s). It is important to make sure that any deviations or errors associated with this activity have been properly investigated.

	The next picture in the story is the actual manufacturing of the product. The picture here is a master batch record where the actual amounts of the actives and excipients are mixed together and formulated into the final product. In this particular photograph, it is important to notice the foreground as well as the background. The foreground should be the confirmation that all the materials used were appropriately discharged using calibrated equipment in a suitable environment. Also in the foreground should be some indication as to whether the manufacturing rooms were properly cleaned and cleared before the start of the next batch. The main focus of the picture should be the details of the batch manufacturing itself. Things to notice would be: 

		Were the materials sequenced/combined in the proper order (if this matters)?

		Were the materials mixed and stirred for the required length of time? 

		Were the results of any in-process testing with in specification(s)? 

	
	Attention needs to be paid to make sure that any deviations during this phase of production have been resolved.
	
	Another focus of the picture should be the behavior of the operators, especially if your product is processed aseptically. It is also important to make sure that operators signed (this could be electronically) in the appropriate places indicating they performed the work. If required, there should also be an indication that another employee or a supervisor witnessed the work. This is particularly important when verifying the right ingredients were discharged to the line to make the right product with the right dosage amount. Attention should also be paid to making sure any deviations or investigation have been thoroughly investigated and closed before releasing the product. The background of this activity should focus on the training of the operators to perform their functions, robust process validation, the qualification of cleaning materials to prevent cross or microbial contamination, and other routine maintenance and monitoring procedures that maintain the manufacturing area and lines to an acceptable state of control. The background also should include results of environmental and personnel monitoring (if appropriate), media fills for aseptic processed product, particulate-matter monitoring, smoke study results, etc.

	The next photograph in the batch record tale is the packaging of the final product into its primary container. The foreground in this photograph should be on the release of the labeling and confirmation that the lot number and the expiration date assigned are appropriate. The main picture should center on making sure there were no component mix-ups or line stoppages that would compromise the product during the packaging phase of the operation. Again, attention needs to be paid to make sure that any deviations during this phase of production have been resolved. Background for this photo includes container-closure integrity and stability.

	There is actually no specific order in which the information/photo should be reviewed. Some reviewers like to wait until they have everything before they start their review so they can see the whole story upfront; others like to disposition or view the pictures as they come in and try to visualize the final picture. Either way is acceptable for batch record review. Many companies use a checklist to make sure all the elements of the master batch record are included in the product batch record. This is an acceptable practice and, when coupled with a thorough review of the contents of those elements, you should be able to rest assured that you will be able to have confidence in releasing product batches.

	When referring to this article, please cite it as S. Schniepp, "A Look at Batch Record Review," 

Articles

The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

A Look at Batch Record Review

	Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
	 

Q: I am a quality control (QC) manager of a contract test laboratory. I am going to be upgrading the laboratory and would like to know if you have any advice on how I should approach this activity?


	
	A: Upgrading a laboratory is an exciting activity but it needs to be approached with a thoughtful, well-constructed plan that does not interrupt the business needs of your clients. You mentioned that you are a contract test laboratory, which would imply the products you test could include clinical trial material, final product dosage forms, and potentially, APIs. In addition, you might be performing final product release as well as stability testing. Regardless of the testing you are performing, the first step of this process should be to notify your clients of your intention to upgrade. This is important because some clients may not wish you to perform their analyses on new equipment. You will need to work with these clients closely to make sure you understand their concerns and that you address them before decommissioning any equipment used to analyze their materials.

	The next step in the process is to take inventory of the equipment you have and start making some risk-based decisions on a project plan that will define what should be replaced, in what order, and what the requirements are for each. Regardless of which piece of equipment you decide to tackle first, there are several issues you must address with every replacement. If you are simply upgrading to a new piece of equipment to replace an aging piece of equipment (i.e., like for like), your requirements will be straightforward. If you are replacing an existing technology with a significant upgrade or different technology, a more comprehensive approach will be necessary. In all cases, you will need to make sure the current equipment is performing adequately and is still capable of generating reliable results. 

	Like-for-like equipment or new technology?

	For a simple like-for-like replacement you should perform installation qualifications (IQ) and operational qualifications (OQ) on the new equipment. The next step in the process would be to execute a performance qualification (PQ) and a comparison protocol to show the results obtained with the new equipment are the same as the results obtained with the old equipment. In many cases, the PQ and comparison may be combined into one document. If the results from the protocol match up, you can decommission the old equipment and start using the new equipment. 

	When changing from one type of technology to a different, more sensitive technology, there are more decisions that need to be considered. You need to work closely with your client on the specifics of their product so you can perform the transition with minimal disruption to their and your product flow. These more complex upgrades require a lot of upfront planning. As with the like-for-like replacement, you need to make sure the current equipment is operating appropriately. As before, you need to perform the IQ and PQ on the new equipment. It is in the PQ and comparison protocol where attention to detail will be crucial to execution. For instance, when changing from high-performance liquid chromatography (HPLC) to the more sensitive ultra-high pressure liquid chromatography (UHPLC), you need to be prepared to address the possibility that you could see some unknown peaks during the analysis. These peaks need to be identified and characterized before you can continue with the transfer. While this investigation is underway, you need to determine the suitability of the product for release and the potential impact these unknown peaks might have on the stability of the item being analyzed. If the method being converted is a US Pharmacopeial Convention (USP) method, you need to be sure that the new methodology generates results that are equivalent or better than the results obtained using the compendial method. The comparability protocol details will help you address the unforeseen circumstances should they occur during the execution of the protocol. The issues arising from the conversion of one method to a more sensitive method need to be fully addressed and explained before decommissioning the obsolete equipment.

	There may be situations where you will need to maintain both the new and the old equipment operational at the same time. For instance, you may want to continue to monitor the stability of a product on the equipment the analysis was started on and not change to the new equipment until the last stability time point has been analyzed. In this case, you will want to maintain the old equipment while utilizing the new equipment for release and future stability monitoring. These situations need to be discussed with your client and included in the laboratory timeline for transitioning the laboratory.

	Another important element of transitioning a laboratory is making sure your analysts are properly trained on the new equipment while maintaining expertise on the old equipment until the transition is complete. Many companies selling analytical equipment have experts to perform the necessary training and to help address issues that may come up as the analysts become more familiar with the equipment. It is important for the laboratory and your clients that analysts are properly trained so they can deal more effectively with problems that occur during the transition period. The more training and familiarity the analysts have in running the new equipment, the less disruption there will be to operations.

	When introducing new equipment and new methodologies to a laboratory, it is important to have a comprehensive implementation plan that discusses what equipment you will introduce, the timeline for the introduction of the equipment, how you will investigate unexpected analytical results during the transition, and how you will make sure your analysts are appropriately trained while causing minimal interruptions to operations and your clients.

	Putting your plan down in writing and discussing it with your clients up front will save you a lot of time and minimize delays as you implement your plan.


	Vol. 41, No. 6
	June 2017
	Pages: 74-73

	When referring to this article, please cite it as S. Schniepp, "Ensure Quality in a Contract Test Laboratory," 

Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Ensure Quality in a Contract Test Laboratory

Q: I am in charge of the internal audit program at my company and am wondering if you have any suggestions on how I can make this activity more valuable for my company?


	
	A:  Internal audits are part of management responsibilities (1–3) and can provide valuable information and offer many benefits to an organization. The information obtained during the audit can be used in many ways to help your organization grow and continually improve its operations. How you approach the internal audit function will help the organization understand the advantages of supporting an effective, well-run internal audit program.

	If designed and implemented appropriately, internal audits can provide valuable information that can be used to prevent issues before they become compliance concerns during a regulatory inspection. Issues can be identified and corrected before the regulatory authorities or current/potential clients identify them. If these issues can’t be completely remediated before an external audit, a plan to correct them can be established and action taken to mitigate them. Having corrective actions in place before others identify the issue may lessen the impact of the observation and instill confidence that your quality system is under control and there is a process in place for continuous improvement. In addition, the internal audit can be used for training staff and communicating valuable information to the organization.

	The object of an internal audit is not to pretend to be the regulatory authority and show up unannounced but rather to work in cooperation with your colleagues to identify and solve potential issues. An effective program establishes a partnership between the audit function and the departments being audited. The ideal tone for an internal audit should be a team-oriented activity that is instructive, informative, open, honest, and inclusive. There are several factors that help contribute to establishing this tone. One way to set the proper tone is to publish the audit schedule in advance and make sure the functional areas are informed of the schedule. The audit itself should be forward thinking and unlimited in scope. The auditors should work with the functional area and talk with as many employees as possible to identify the issues of concern. Individuals who are responsible for performing the day-to-day activities often have the best insight as to what is working and what needs to be improved. Excluding them from participating in the audit process might result in overlooking a serious issue that could come up during a regulatory inspection. To be able to get the most valuable information about the potential compliance issues facing the organization, internal audits should not be judgmental or antagonistic, or have a ‘check the box’ mentality in execution. They should also avoid looking retrospectively in lieu of looking forward.

	The behavior of the auditors during the audit is also important to obtaining valuable information. Auditors should be direct and avoid asking questions designed to stump people. The auditors should take this opportunity to teach by explaining why they are asking particular questions and providing the regulatory citation for the inquiry. Another important behavior is the ability to listen to the answers to the questions and refrain from judging. The auditor should adopt a proactive approach to the audit and look at items that are infrequently assessed. Above all else, the auditor needs to be friendly.

	The exact same behavior defined for the auditor should also be the exact same behavior displayed by the auditees. Auditees should be direct and avoid deflecting or obfuscating answers. They also need to be instructive and take the time to explain why they do things the way they do them. They need to listen to the auditor’s concerns and not overreact to the question being asked. They should be proactive and point out things of concern and seek advice on how to remediate them. Both parties need to remember they are not the enemies, rather they are the partners.

	Internal audits are a valuable tool for identifying issues before others identify them. The information obtained during the audit can be used to improve your processes, and the audit process itself can be another tool to help train employees. If you consider the internal audit as a gap analysis for your processes and set a tone of partnership and cooperation, you will find that the audit program and the information obtained from it will become a valuable resource for the organization rather than an unwanted intrusion into operations.

 820.20, Management Responsibility
	2. European Commission, 

, Volume 4, Chapter 1, Pharmaceutical Quality System.
	3. ICH, Q10 

	When referring to this article, please cite it as S. Schniepp, "Making the Most of Internal Audits," 

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.

Making the Most of Internal Audits

Managing the relationships between clients and contract manufacturing organizations (CMOs) can be difficult as the pharmaceutical landscape and its related supply chains become more global and complex. One of the best tools to achieving a good working relationship between a client and their CMO is the use of a well-drafted, clear and concise quality agreement. To accomplish this, it is important to understand the different types of clients as well as the types of CMO models existing in today’s environment.

	In May 2013, FDA published draft guidance on quality agreements, which was finalized in November 2016 (1). Although written quality agreements are not explicitly required under existing CGMP regulations, they are required by the European regulations. Chapter 7, Outsourced Facilities, in 

 Volume 4 states, “There must be a written Contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party” (2). The FDA final guidance is titled 

Contract Manufacturing Arrangements for Drugs: Quality Agreements

 and, like all final guidances, represents FDA’s current thinking on the topic. The need for quality agreements is underscored by 21 

 (CFR) 200.10, Contract Facilities that states, “Section 704(a) of the Federal Food, Drug, and Cosmetic Act specifically authorizes inspection of consulting laboratories as well as any factory, warehouse, or establishment in which prescription drugs are manufactured, processed, packed, or held” (3). This section of the regulations goes on to state, “The Food and Drug Administration is aware that many manufacturers of pharmaceutical products utilize extramural independent contract facilities, such as testing laboratories, contract packers or labelers, and custom grinders, and regards extramural facilities as an extension of the manufacturer’s own facility.” And finally, 21 CFR 211.22, Responsibilities of the Quality Control Unit, states, “The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company” (4).

	The emergence of CMOs and virtual companies has been at the forefront of some of the challenges the industry is experiencing. With the finalization of the FDA guidance, it is an opportune time to revisit the concepts and ideas regarding quality agreements.

	Quality agreements should not be limited to what is meant by traditional manufacturing but should be expanded to include the support activities necessary to producing a final product. It is important to put into context what is meant by “manufacturing”. For the purposes of this article, “manufacturing” will be considered anything to do with the manufacturing, testing, processing, packaging, or holding of the product including the procurement of the active ingredient, excipients, and packaging materials, including labeling, used to assemble the product.

	Another important issue to understand is the different client and CMO business models existing in the industry today. The various outsourcing models range from a single outsourced activity to the full range of activities to produce the product. Partners in the contract-manufacturing niche also include the full spectrum from small to large and from early development to late-stage generic drug companies. The complexity of the business models emphasizes the need of the industry to employ a meaningful quality agreement that focuses on defining who is responsible for what in the relationship and what the communication scheme will be between the organization(s). 

	Often the major issues include the actual logistics of the agreement itself.  While there is obviously no one model for format and content, each party usually would like their own format for consistency. The real issue, however, is to agree on the scope and level of detail.

	Looking at the situation from both sides might help in understanding the complexity of the issue. A CMO will have multiple clients. Each client will have different information they want highlighted in their quality agreements and will want to use their own quality agreement template. Keeping track of numerous commitments can cause regulatory risk for the CMO, particularly if one client wants to have a different approach to an issue than another client. CMOs should look for clients who understand the regulations and can evaluate the CMO’s systems against those regulations rather than demanding the CMO conform to their way of doing things. Clients should look for a robust quality system and an open and communicative culture when choosing a contract organization to perform work for them.

	Let’s look at an example where robust quality agreements and a good communication scheme would have helped avoid and alleviate a regulatory concern. Keep in mind that the contracted parties involved in this scenario are unaware of the multiple contracts negotiated by the client, none of the contracts specify which party is responsible for investigations, and there is no mention in the quality agreement about how the parties will communicate in the event of an issue.

	The CMO was manufacturing clinical-trial materials for a client. The CMO was scheduled to perform the sixth manufacturing run of the clinical material when they noticed a different physical appearance to the API during incoming inspection. The Certificate of Analysis accompanying the API indicated the material met the necessary specifications. The CMO was only capable of performing an incoming identity test because the client had contracted for the API release testing to be performed by a contract test laboratory (CTO).

	The CMO contacted the client and expressed their concerns with the appearance of the incoming API. The client said that they were not concerned with the physical appearance of the API and told the CMO to manufacture the clinical-trial material. Once the manufacturing run was completed, the CMO, per the quality agreement, sent the final product to a different CTO. The product failed final product release testing, and the CTO opened an out-of-specification investigation.

	The CTO found no error attributable to the laboratory and contacted the client that they thought there was a problem with the manufacturing run. The client contacted the CMO and told them to investigate the incident at their facility only. During the investigation, the CMO documented that they felt the failure of the product to pass the final product testing was due to the unusual appearance of the API and requested permission from the client to talk with the API manufacturer. The client denied the request; the clinical trial batch was placed on hold by the CMO; and the investigation was never closed out.

	During a regulatory inspection, the inspector wanted to know what the outcome of the investigation was. The CMO had to tell the inspector that they could not complete the overdue investigation because they were unable to talk to the API manufacturer and the client had told them that they investigated the API manufacture and could find nothing wrong with the API. The CMO said the investigation was still open because the most probable root cause identified was the API, but it could not be verified. The result was that the CMO, the client, and the API manufacture were all issued FDA 483s and the product approval was delayed until the issue could be resolved.

	How could a more robust quality agreement and a communication plan have helped resolve the situation? There are a couple of recommendations to be made. The first is when there are multiple quality agreements involved, the client should make sure each of the parties are aware of each other through their quality agreement. The client should also define that they will facilitate any communications between the various parties involved in the manufacturing including the testing laboratories, packagers, etc. In addition, the quality agreements should state who is responsible for the various activities including the facilitation and resolution of investigations.

	There is no right or wrong in crafting quality agreements. A good quality agreement will take into consideration the needs of the CMO, the client, adherence to compliance, and regulatory commitments of both parties. If both parties keep these principles in mind, they will have a great working relationship despite the quality agreement.

Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry

 (CDER, CBER, CVM, November 2016).
	2. European Commission, 

, Volume 4, Chapter 7, Outsourced Activities.
	3. 21 

 211.22, Responsibilities of the quality control unit. 


	Vol. 41, No. 3
	March 2017
	Pages: 58-61

	When referring to this article, please cite it as S. Schniepp, "Quality Agreements: Managing Global Relationships," 

A robust quality agreement and good communication scheme can help avoid and alleviate regulatory concerns.

Quality Agreements:Managing Global Relationships

	Q. I am a small-scale parenteral manufacturer and have been approached to support a clinical program through Phases II and III.  What considerations are important for the small-scale production lots?

	
	A. This situation always raises some interesting discussions. The statistical assurances for sterility for normal commercial lots are not available because of the usually small lots during clinical production. At the same time, the need to minimize any unanticipated clinical risks remains high. The best advice is to consult the regulations and determine what requirements you must meet to help ensure the clinical material you are manufacturing is safe. 

	Clinical-trial material batches can range from as few as 200 to as many as 5000 units or more. It may not be feasible for these small-size batches to be produced on a traditional manufacturing line. In fact, some of the batches might be manufactured under a laminar flow hood by manual aseptic processing. It is important to remember that sterility assurance of the product must be maintained even when the clinical-trial materials are being prepared by hand because of the small lot sizes required. For these small-scale batches, manufacturers need to adhere to the recommended requirements for control of the environment as defined in FDA’s aseptic processing guidance (1), the Parenteral Drug Association’s 

 (2) on manual aseptic processing, and in 

 Volume 4, Annex 1 (3). In other words, the environment must be maintained and monitored with the recommendations specified in the documentation governing aseptic processing. 

	Properly maintaining an environment suitable for the manufacture of aseptic drug products regardless of batch size is not as clear-cut as it seems. Quality personnel responsible for batch release need to take into consideration a number of factors before the lots in question can be released. These factors include assuring appropriate use of disinfectants before, during, and after manufacturing; proper gowning and aseptic technique of the operators; and making sure the environmental and qualification data support the operations.

	So, what does this all mean? It means the company must have a robust program in place to support the sterility of the batch regardless of the lot size. There needs to be a cleaning program defining the proper use of disinfectants/sporocides before, during, and after processing. It means there should be a gowning qualification/requalification program for personnel responsible for the product manufacturing. The gowning program should define how operators are initially qualified, how they are monitored for microbiological excursion during gowning, during manufacturing, and upon completion of manufacturing activities. It should also define how operators will be periodically requalified and how operators will be requalified in the event of an out-of-specification result. Operator aseptic technique should be tested through the conduction of media fills representative of the actual manufacturing runs. At a minimum, media fills should be performed annually.

	There also needs to be a facility maintenance program that challenges the appropriateness of the air handling system. Establishing a periodic maintenance program for your high-efficiency particulate air (HEPA) air filtering system and performing periodic smoke studies to make sure the airflow is suitable for aseptic operations should provide the assurance that the airflow system is in control and is functioning appropriately. 

	In addition to the above recommendations, the company should have a program to control incoming components. Components used in the manufacture of aseptic processing on a small scale need to be rendered pyrogen free before being introduced into the manufacturing area. Small-scale batches will not be taking advantage of continuous processes associated with large-scale lot manufacturing, so consideration must be given to how the materials and components will be introduced manually into the manufacturing area. This will require even greater emphasis on operator technique. In some instances, the manufacturing equipment used in small-scale batch production is portable, so this program should also encompass the introduction of the necessary manufacturing equipment into the production area.

	There needs to be an established environmental monitoring program. The environmental monitoring program for small-scale batch production should provide the information on the quality of the aseptic processing environment including any ancillary areas such as the equipment/component processing area, gowning rooms, laminar flow hoods, floors, ceilings, walls, and equipment surfaces including those that come into contact with the product components as well as the product itself.

	Determining the appropriate monitoring locations should be determined through a comprehensive risk evaluation that should periodically be reviewed and updated to reflect the most current operating conditions. 
	Finally, there needs to be consideration to final product testing and the appropriate number of samples needed to ensure the product is sterile and safe for patients. The samples needed for testing should be taken from the beginning, middle, and end of the manufacturing run and the number taken should be reflective of the batch size.

	Successfully manufacturing small-scale parenteral batches suitable for patients requires many of the same procedures and controls needed for large-scale parenteral manufacturing. If you keep in mind-regardless of batch size or manufacturing process-that the ultimate goal is to assure the sterility of the product throughout the manufacturing run and you use the data collected to determine the suitability of your processes, you should be able to produce any size batch in accordance with regulatory expectations.

Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing, Current Good Manufacturing Practice

 (CDER, September 2004).
	2. Parenteral Drug Association, 

Technical Report #62, Recommended Practices for Manual Aseptic Processes

 (PDA, April 2013).
	3. European Commission, 

 Volume 4-Annex 1, Manufacture of Sterile Medicinal Products (European Commission, Nov. 25, 2008).


	Vol. 41, No. 2
	February 2017
	Pages: 82, 81

	When referring to this article, please cite it as S. Schniepp, "Ensuring Sterility in Small-Scale Production," 

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, 
discusses how to ensure sterility when manufacturing small-scale parenteral batches.

Ensuring Sterility in Small-Scale Production

	Q: I am in charge of training for a contract-manufacturing site with approximately 350 employees. The budget for my department was recently cut, and now I am struggling to get my employees to training. I know that this will become a potential item when my clients inspect me. Do you have any suggestions on what I can do to remedy this situation?

	A:  This is a great question. It seems cutting the training and travel budgets are the first austerity measure companies take when they are facing some budgetary difficulties. In my opinion, training should probably be one of the last areas that should have its budget cut because training is one of the key elements management can use to assure their commitment to consistently producing a high-quality product. It is also a GMP requirement.
	
	The US regulations, 21 

) 211.25, define personnel qualifications and state, “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them” (1).

	Just because your budget is cut, however, doesn’t mean you can’t make sure employees receive meaningful training. There are many organizations and companies that offer webinar training on topics ranging from “How to Write Effective SOPs” to “How to Perform an Effective Technology Transfer” to “Risk Management Strategies for Quality Management in the Pharmaceutical Industry.” Some of these webinars are free and some require a registration fee. They are usually 90 minutes in length, and many offer an opportunity to ask the speakers questions through a chatroom feature. If you are unable to listen to the webinar live, you may have the option to purchase a recording of it and listen to it at your convenience. The recorded option offered with these webinars can be valuable for training employees who work on the second and third shifts that can often be challenging. The companies offering these webinars advertise them well in advance of the event and often send out multiple reminders. The advertising for the webinars highlight who will be speaking, their qualifications, what they will cover in the training, and what you will learn as a participant. In addition, they will also make recommendations on who should attend so you can determine if this is appropriate training for your employees. In some cases, the webinar may offer continuing education credits for attending. This information should be printed out and used to demonstrate the appropriateness of the training during an audit.

	FDA also offers training through the FDA Learning Portal for Students, Academia and Industry at www.fda.gov/Training/learningportal. This training, FDA reports, “… provides educational resources related to FDA’s regulatory, product quality, and safety responsibilities. In each section you’ll find educational materials such as lectures and courses as well as web pages related to the particular topic.”

	Some of the topics available include courses titled FDA 101, FDA’s Regulatory Framework, Current Initiatives, Human Drug Approval and Post-marketing. The modules also provide a course objective so you and your employees will understand what they should know after completing the training. For example, there is also a module called 

, which, FDA states, will provide an understanding of FDA’s public health mission and how the agency is organized to carry out its mission (2). FDA also broadcasts some of its public meetings depending on the topic.

	The agency’s public meeting regarding its 

Request for Quality Metrics Guidance for Industry

 was a great way to learn about the new guidance and what industry colleagues were thinking. This is another way employees can keep up-to-date on the current issues facing the industry.

	Finally, for some employee groups, internal training consisting of discussions of current topics that can be found from industry warning letters, 483s, or new guidance documents may be a low-cost alternative to a formal training experience. These discussions can be led by qualified company personnel and can cover not only the specifics of the issues but the rationale behind them. As with all other training, these discussions should be documented in your training system.

	The bottom line is even though your budget has been cut there are still opportunities to get your employees the required needed training that will satisfy your customers in audits. You should sign up to receive emails from companies and organizations that offer online training, review them to determine if they are applicable to your operations, determine who should attend from your company, and make sure you document their attendance for their training record. In addition, you should also monitor the FDA website for potential upcoming webcasts, past webcasts, and other public offerings that will help you and your employees receive the necessary training even with a limited budget.

 211.25, Personnel qualifications, April 1, 2016.
	2. FDA, 

, www.fda.gov/Training/learningportal/ucm417363.htm#overview

	When referring to this article, please cite it as "Options in Employee Training," 

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.