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

Susan J. Schniepp

Ask the Expert: Training for a Skilled Workforce

Geopolitical stressors, such as trade policies put in place by the Trump administration in the United States, have pushed some pharmaceutical companies to invest in moving production and building new facilities in the US (1). With expansion, however, comes the need for qualified personnel to run operations in these manufacturing facilities.

But the industry has been struggling in recent years in obtaining the personnel with the proper skill sets to meet demand. And because pharmaceutical development and manufacturing are regulated industries, training personnel is crucial to ensure safe and effective medicines reach the patients that need them. So how can pharma companies ensure their staff, new and current, are up to speed on the latest tools, processes, and regulations?

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates (RCA), a Nelson Labs company, and Siegfried Schmitt, PhD, VP Technical at Parexel, delve into the complexity of training in this episode of Ask the Expert.

“I think the question on training is really fascinating, says Schniepp. “We do keep hearing there is a shortage of workers for these facilities. I think there's going to need to be a lot of training fast to bring workers up to date and up to speed to man these new facilities. And I think the whole concept of training has changed from internal, where we did it internally with our little PowerPoint slides and somebody watching to more virtual training has undergone in the last 2030, years, massive changes, and we use AI tools.”

“We need to talk about delivery [of training],” Schmitt stresses. “There are many more ways to deliver these days than we had 1020, years ago. You and I, we've been a while in this industry, but certainly we find that almost every day we learn something new, we hear something new, we had no idea about something interesting comes about. So, learning doesn't stop. And the other thing that I certainly look back to when, when I started in industry and I needed to learn all the basics, it was learning by watching, by being told by the people who have been in the industry for a while. So, it's not so much in the first instance about reading the books or reading the standard operating procedure, reading the instruction. It's a lot about learning from those who've done it before. So there needs to be a mix, I'd say. You can't just throw out instructions and give it to people and say, ‘here you read and you understand and you sign off’. You still need some experienced workforce that holds your hand and that guides you through what needs to be done.”

Click the video above to watch Sue and Siegfried answer the following question:

“My company is building new manufacturing facilities in the US, which will require additional workforce and skill sets. What kind of training is required and how can we deliver that training?”

Cole, C. How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains. 

https://www.pharmtech.com/view/how-100-pharmaceutical-tariffs-will-impact-domestic-manufacturing-and-supply-chains

Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs company

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of 

Siegfried Schmitt, PhD, VP Technical at Parexel

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets. 


Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com

Q: What is the best way to perform batch recovery procedures for the manufacturing of pharmaceutical products?

A: Pharmaceutical batch recovery is a critical process in the manufacture of medicines. The batch recovery process is performed when there is a deviation during manufacturing, and the situation is such that there may be a potential to “recover” the batch while still ensuring the final product meets quality, safety, and compliance standards. Batch recovery involves identifying and rectifying any deviations or issues that occurred during the production of the specific batch in question by conducting a thorough investigation resulting in definitively identifying the root cause of the deviation. The investigation should involve collaboration between quality assurance, production teams, and regulatory authorities. The batch recovery process should define the details of the root cause analysis as well as any future corrective and preventive actions to prevent recurrence. This will help determine if the batch is suitable for recovery.

The main challenge in batch recovery is quickly identifying the root cause of the deviation. Investigations can sometimes be complex and may take more time to come to root cause. This impacts the ability to be able to recover the batch especially when dealing with time sensitive products that may degrade while awaiting the outcome of the investigation. Regardless of the product involved and the criticality of the situation, care must be taken to maintain consistent, thorough documentation, and timely communication with management and regulatory authorities to guarantee the recovered product meets all quality, safety, and regulatory standards, thereby ensuring patient safety.

One of the most important elements in considering batch recovery steps is making sure that a robust quality control system has been implemented across the company. The culture of the organization must be mature enough before undertaking batch recovery operations. This includes, but is not limited to, having appropriate risk analysis procedures, robust documentation and change control procedures, a highly trained staff, a comprehensive investigation process, and adherence to data integrity requirements. Continuous improvement and regular facility audits will help prevent the issue from recurring in the future.

The decision to perform a batch recovery is a difficult one. It is important to understand when a batch recovery procedure can be utilized and when it would be inappropriate to try to and recover a batch. The determination to perform a batch recovery will depend on the severity of the deviation and if the root cause that prompted the deviation was successfully identified with documented supporting evidence. Batches that have more than one deviation during that manufacturing process should not be considered suitable for batch recovery.

The ideal situation is to try and avoid batch recovery situations by having a robust quality system that values continuous process improvement based on identifying root causes for deviations and proactively implementing changes. It is essential to follow best practices and proactively address manufacturing challenges upfront. Identifying the true root cause of the deviation not only helps minimize cost, especially when expensive active ingredients are involved, but helps maintain product integrity that meets regulatory commitments. Even if you have all the necessary elements imbedded into the quality system, unexpected occurrences may lead to a scenario where the company needs to determine whether a batch can be recovered. By following best practices and employing continuous process improvements based on robust investigations and corrective and preventative actions, manufacturers can potentially recover a batch that might otherwise be rejected.

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, and a member of the 

®
Vol. 49, No. 9
November/December 2025
Page: 26

When referring to this article, please cite it as Schniepp, S.J. Fundamentals of Batch Recovery Procedures. 

Articles

Batch recovery in pharmaceutical manufacturing is crucial when deviations occur, ensuring the final product meets quality, safety, and compliance standards. The process involves identifying and rectifying deviations through thorough investigation, collaboration, and root cause analysis. A robust quality control system, mature organizational culture, and continuous improvement are essential for effective batch recovery. The decision to recover a batch depends on the severity of the deviation and successful root cause identification. Proactive measures and best practices can minimize the need for batch recovery, maintaining product integrity and regulatory compliance.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, outlines the importance of batch recovery procedures in pharmaceutical manufacturing.

Fundamentals of Batch Recovery Procedures

Ask the Expert November 2025: Audits, Inspections, and CDMOs

Contract development and manufacturing organizations (CDMOs) typically have multiple clients who each have specific needs. When regulators perform audits and inspections of CDMOs, it is sometimes unclear who is responsible for any deviations the inspector might have. However, ultimately, the sponsor company is responsible for ensuring that any contract organizations are following good manufacturing practices.

But what happens when a CDMO has a client that has specification and/or requirements that infringe on that contractor’s ability to work with other clients? How should the CDMO respond to audits and their clients? In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company (RCA); Siegfried Schmitt, vice president Technical at Parexel, and Anita Michaels, executive pharma compliance expert and principal consultant at RCA, give advice on how contractors and clients can work together to prepare for inspections and address regulatory actions.

“A lot of CDMOs utilize their clients' inspections to prepare for inspection. But I think you could level up, level that up higher,” Michaels says. “The first thing is you want to have a robust quality system. And you also want to integrate the other five systems into your facility. Then you'll receive, if it's a regulatory authority like the FDA, they could come to inspect you for a GMP or pre-approval inspection, which will be specific to the product they're covering. And then the GMP portion, if you have been approved for a United States product, would cover the six systems. So, I think holistically, a CDMO should prepare, number one, to handle a GMP covering the six systems and have a robust quality system, such as policies in place for your CAPAs [corrective and preventative actions], investigations, deviations, your KPIs, your tracking, and trending holistically across your facility. And then also understanding the approach for a preapproval inspection for your clients.”

Click the video above to watch Sue, Siegfried, and Anita answer the following question:

“How does a CDMO organization handle multiple client input and perspective with regard to general GMP inspections without compromising or setting up different standards within their Quality Management System?

Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates, a Nelson Labs company

Siegfried Schmitt, PhD, Vice President, Technical at Parexel

Anita Michael, executive pharma compliance expert and principal consultant, Regulatory Compliance Associates, a Nelson Labs company

Anita Michael is RCA’s Executive Pharma Compliance Expert & Principal Consultant. She has 24+ years of global regulatory and quality experience, including 16 years direct FDA experience operating globally as their Pharmaceutical Expert, FDA Investigator and FDA Pre-Approval Manager. Anita has excellent interpersonal, empathetic communication and client management skills that enable her to skillfully coach and collaborate with clients at the highest levels of an organization and prepare them for successful FDA inspections (ANDA/NDA/BLA/PMA Pre-Approvals) and global regulatory and quality assurance audits across Biotech, Biologics, Sterile Operations, Drug Substances, and 503A/B. She has been Keynote Speaker for the Pharma Industry and internally to the FDA throughout her career.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how CDMOs can best handle regulatory inspections and client expectations. 

Audits, Inspections, and CDMOs

Ask the Expert: Commenting on Draft Regulations

Regulatory agencies, such as FDA and the European Medicines Agencies, and other industry standard setting bodies, such as the International Council for Harmonisation and the US Pharmacopeia, often publish draft versions of the guidance documents they are developing to gather feedback from the public, which includes those scientists and engineers working in the pharmaceutical industry. But who should comment and why?

“You know, there's an opportunity before regulations get approved for industry to participate and offer their comments on the regulation. This has worked in many cases where, for instance, in the US, way back in 2013, 2014, there was a proposal for metrics. And it was through the commenting period that was open to the public, where industry

was able to put forth a case to get the agency to consider some other metrics

that we thought were important, that they were not originally in the proposal,” explains Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates. “So, the way it works is anytime there's a new regulation or a change to an already existing regulation, the FDA will announce it in what we call the Federal Register. It's kind of like the daily newspaper for the government. It's that time when they open it up for comments from industry. And so, it's very important because you can change the final regulation before it becomes official by putting your comments in through this vehicle.”

“Absolutely anyone can comment,” stresses Siegfried Schmitt, PhD, is vice president, Technical at Parexel. “You don't have to be the ultimate expert. If you feel you have something to say, absolutely, you can. Now, perhaps it is advisable or sensible to not just comment as an individual but perhaps comment through your company. Perhaps your company as such is interested in providing comments.”

Both Schmitt and Schniepp also suggest commenting through a trade association, such as the Parenteral Drug Association. “I like commenting through industry associations because usually, they gather a group of experts together proposed regulation topic, And you get to hear not only your perspective voiced, but other experts' perspectives voiced,” Schniepp says. 

“I often see regulators publishing draft guidance documents for public consultation. Can I and should I comment?”

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Okay, hello, everyone. My name is Siegfried Schmitt. I'm vice president technical with PAREXEL, and I'm one of the Ask the Expert experts for the series here, and I'm Sue Schniepp, and I'm part of regulatory compliance associates, which is a subsidiary of Nelson labs, and I am Siegfried's counterpart for Ask the Expert series.

Okay. Oh, hello, Sue. Nice to see you again. Hi, Siegfried, good to see you too well.

So we got another question here for Ask the Expert series, and this is that there are several new regulations being published in draft in Europe. And of course, there are always some being published in the US as well, and the person writing in was wondering, so how can one do this? This commenting and well, is it the done thing? Because he or she feels well, perhaps this is not something that everyone should do. Can you perhaps comment on this?

Yeah, you know, there's an opportunity before regulations get approved for industry to participate and offer their comments on the regulation. This has worked in many cases where, for instance, in the US, now you're the expert on the European arena, but in the US, way back in 2014 2013 there was a proposal for metrics, and it was through the commenting period that was open to the public, where industry was able to put forth a case to get the agency to consider some other metrics that we thought were important, that they were not originally in the proposal. So the way it works is, anytime there's a new regulation or a change to already existing regulation, the FDA will announce it in the what we call the Federal Register. It's kind of like the daily newspaper for the government, and it's that time where they open it up for comments from industry. And so it's very important, because you can change the final regulation before it becomes official by putting your comments in through this vehicle.

That's very interesting. Thank you. Sue and perhaps to add, in Europe, not every regulation is open for public comment, but many are, and so as the person writing in was asking is, can anyone do this? Absolutely, anyone can comment. You don't have to be the ultimate expert if you feel you have something to say absolutely, you can now perhaps it is advisable or sensible to not just comment as an individual, but perhaps comment through your company. Perhaps your company as such, is interested in providing comments many companies do, or perhaps through an industry association like ispe, PDA, raps, you name it there. There are many out there. So perhaps so, because you have done this many times, you could say a few words why this is such a good way to comment. If you do it through an industry association.

Well, I like doing it through the industry associations because usually they gather a group of experts together on the topic, proposed topic, regulation, topic, and you get to hear not only your perspective is voiced, but other experts perspectives are voiced. So I like the broad scope information that working with a team of experts on this topic brings you, it makes the comments more robust. And I, I think the trade organizations have a certain because they're representing multiple experts, multiple companies. There's a little bit more weight kind of associated with it, from my perspective as a commenter, right rather than an individual. I'm not saying that the FDA or the regulatory authorities puts more weight in the comments of a trade organization over an individual. I'm saying that as. As a commenter, I feel there's more weight in my comments when they go in under a trade association. That's a personal feeling, though.

Well, to pick up on this Sue, particularly if you're an inexperienced person in commenting on regulations, I think it's very valuable to be part of such a group, in an industry association, because many of those who will be part of this group will have done it before, and there are certain things that regulators will simply ignore if you put things in that cannot be acted upon. So you can learn an awful lot how you can effectively influence, a regulation, a guidance, and what things are best left out. So it's a very good learning experience, and it helps one understand how, in fact, these regulations are being put together.

Yes, it puts a perspective for the the new person who might be new to this commenting game. I think we've restricted our discussion right now to regulation proposals, but there are other publications that are open for comment, such as the European Pharmacopeia or the United States Pharmacopeia, and it's important for people to understand those two have a comment period where You can influence the outcome of the work that they're doing and establishing, you know, the standards and some of the guide interpretation of guidances and how to enact those do?

They also have these expert advisory groups. I believe they're pharmacopeias.

They do. They have expert committees, both in the EU and the USP, I think that I'm not sure about the Japanese Pharmacopeia. And those advisory panels will propose the change to the Pharmacopeia, and then it will go, usually, through what they call, at least in the US, it's called the pharmacopeial forum, where it's open for review. I forget what they call it in Europe, but it's kind of similar to the same process.

Okay, yes, and perhaps, as you say, it's not just these draft regulations that are open for comment, where you can influence what will be the ultimate regulation, or how things will be regulated, because you and I, we are both members of industry associations and help them write best practice guides, yes, and these best practice guides are sometimes even cited by the agencies like FDA and Emma and so on, because they complement the regulations. Yes, not everything can be in a regulation. Certain things are better said in a guidance document, which may come from an industry association. Well,

there's also, and you're very active in PDA, as I am, and to use them, and as an example, we do publish technical reports on topics that may not quite have made it into the regulation, but are important and implementing some of this standards and expectations of regulatory authorities, and those often can be cited by the regulators, as as you said, Best Practice documents indeed. So coming back to the question that was asked of us, really, it is, it is very advisable to get involved. You do not have to be the ultimate expert, but you learn for yourself also about the processes. You learn about how regulations are being put together, and how, really, industry does have quite an influence on how these regulations will be written. So we can only encourage, I think, become part of these associations, be become an active part, not just the consumer, yes, and I think there's many more, you know, you're touching on a topic near and dear to my heart there. Siegfried, it's not only just commenting, but try to get involved. You know, if you think you have an expertise, maybe you want to put in your nomination. And for a USP expert committee or EP expert committee member. There's also American National Standards Institute. If you're in the US, you can join ANSI, or you can try to join a organization that works to develop ANSI standards. And then there's Amy, right So, and I know there's European organizations, maybe you have some of those that you but to put your name in the hat and say, I'd like to volunteer and I'd like to be on this committee is another great way to try and influence or get the best regulation out there.

And again, if you do work for a company, then your managers will be very interested in this, because it really helps you, but it also helps the company. It raises the profile, doesn't it?

Well, thank you very much. So I think we've covered this topic for today.

I agree. Thank you. Siegfried, always a pleasure to talk with you.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, Parexel, give their opinions on why those working in the pharmaceutical industry should lend their voices to draft regulations.

Ask the Expert: Questions about Real-World Evidence and Supply Chain Security

The lifecycle of a drug product doesn’t end once the drug is put on the market. It extends beyond, where real-world evidence from patient use of the product provides data that are often relied on in the continued safety testing of drugs or in the development of new drug products.

“Real-world evidence is part of the pharmacovigilance activities, and these are obviously mandatory for all marketed medicines,” explains Siegfried Schmitt, vice president, Technical, at Parexel. “Real-world evidence collation wasn't really required in the past, but it is now. And, in my opinion, it's very likely to stay, given the benefits that real-world evidence delivers. And so, therefore, the real-world evidence for the product must be gathered for as long as you keep the product on the market.”

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, goes on to explain that data about a product must be collected for the product’s lifetime, because of the potential for unknown side effects once used by patients. “You get indications or side effects, [when] you are in the clinical trials. But then once you open it up to the greater population, and everybody can take the medicine, you get more side effects, because it's going to affect everyone differently.”

What kind of supply chain problems can occur during the transportation of pharmaceutical products?

“We are not talking about a breakdown necessarily,” Schmitt says. “We are talking about facts like we heard of from the news, where, say, in the United States, a whole truck [of product] vanished into thin air. They stole a complete truck. They didn’t just break into a truck and steal something. There are some ports in Europe where you should never, ever transport pharmaceuticals through; they get stolen by default. A lane risk assessment is a necessity to understand ‘how can you transport safely, securely? Where should you, for example, stop your truck overnight? Is it illuminated? Is it secured? Is it just in the backyard of a motel?’”

Click the video above to watch Sue and Siegfried answer the following questions:

My company just launched a novel, small-molecule drug into the market. For how long do we need to gather real-world evidence to monitor its safety and efficacy?

My company is investigating options for a novel cell therapy for the oncology market. How can we leverage real-world evidence from our own research and from post-market drugs already on the market to choose which direction to go in?

We are a drug product manufacturer, and we take supply chain security very seriously. As part of our internal assessment, we have identified transportation as a critical element of the supply chain. We use several third parties for the transport of our goods. What security aspects should we address?

Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

Siegfried Schmitt, PhD, vice president, Technical, Parexel

Siegfried Schmitt is vice president, Technical at Parexel and a member of 

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, PhD, Parexel, answer questions on the use of real-world evidence for both small-molecule and large-molecule drug development. In addition, they tackle a question on supply chain security problems that arise during transportation of pharmaceutical goods.

Q. What is a contamination control strategy (CCS) and how does it support sustainable compliance and continuous improvement?

 A CCS is required in pharmaceutical manufacturing to ensure product safety, regulatory compliance, and efficient operations. The updated EudraLex, Volume 4, Annex 1 (1) mandates a CCS for sterile manufacturing in the European Union, aligning with similar FDA requirements
(2, 3) in the United States, as well as International Council for Harmonisation (ICH) Q9 Quality Risk Management (4) and ICH Q10 Pharmaceutical Quality System (5) guidelines.

A review of FDA 483s and FDA Complete Response Letters (CRLs) highlights areas for improvement in pharmaceutical manufacturing. Citations have been issued for deficiencies related to microbial contamination, environmental monitoring, and aseptic practices. Addressing these observations is required for drug approvals and to strengthen a CCS.

A CCS is a holistic approach to minimizing contamination by evaluating good manufacturing practices (GMPs). A CCS provides a proactive method for identifying, controlling, and scientifically evaluating quality risks designed to reduce contamination and enhance product safety and quality.

Elements of a CCS include the following (6):

Monitoring controls—personnel, in-process, materials, environmental, utilities, and pest controls

Validation controls—qualification/requalification of personnel, process, analytical methods, facility, utilities, and equipment

Contamination controls—personnel training, hygiene and gowning, process design, vendor material, consumable containers, equipment design, cleaning and sanitization

Quality risk management and risk assessment identify potential contamination sources and assess their impact on product quality and safety

Scientific and technical knowledge to prevent contamination

Personnel management to empower personnel through training. Staff education, awareness, and skills play a crucial role in maintaining contamination control.

A strong CCS serves as an invaluable quality tool, ensuring regulatory compliance while safeguarding product quality, safety, and enhancing the company’s reputation. Let’s embrace its power!

Q. Why is a risk assessment required for a CCS?

Conducting a risk assessment is critical for a successful CCS. It helps to proactively identify contamination sources and their effects, enabling implementation of targeted preventative measures that safeguard both products and the well-being of patients.

Identify hazards and risks before they turn into real problems.

Prioritize control measures based on the severity and likelihood of each risk to enable the allocation of resources to the areas vulnerable to contamination.

Regulatory compliance and a commitment to product quality and safety are essential for meeting regulatory standards in our industry.

Fostering continuous improvement by gathering insights, streamlining processes, and embracing innovative technologies. A proactive approach reduces risks and drives growth. This approach enables us to maintain control at every stage of the product lifecycle.

Encouraging a culture of safety that involves cross-functional team members in the risk assessment process. This approach helps everyone understand and take responsibility for contamination control.

A robust CCS begins with a risk assessment. By proactively identifying and addressing contamination risks, we improve product quality, prioritize patient safety, and confidently meet regulatory standards.

EudraLex–Volume 4–Good Manufacturing Practice (GMP) Guidelines

: Annex 1–Manufacture of Sterile Medicinal Products (2022 revision).

 Title 21, Parts 201 and 211. Current Good Manufacturing Practice for Drugs. 2023.

Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing

Chakraborty, S. and Baseman, H. Contamination Control Strategies: A Path for Quality and Safety. 

, May 8, 2022, pda.org/pda-letter-portal/home/full-article/contamination-control-strategies-a-path-for-quality-safety (accessed Jul. 21, 2025).

Michelle Heiter is laboratory and quality control specialist at Regulatory Compliance Associates, a Nelson Labs Company.

Susan J. Schniepp, is distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company.

®
Vol. 49, No. 7
September 2025
Page: 34

When referring to this article, please cite it as Heiter, M. and Schniepp, S. Effectively Using Contamination Control Strategies.

A contamination control strategy (CCS) is essential in pharmaceutical manufacturing to ensure product safety, regulatory compliance, and operational efficiency. It aligns with EU and US regulations and ICH guidelines, focusing on minimizing contamination through good manufacturing practices. Key elements include monitoring, validation, contamination controls, and personnel management. A risk assessment is crucial for identifying and prioritizing contamination risks, fostering continuous improvement, and maintaining regulatory compliance. A robust CCS enhances product quality, patient safety, and company reputation by proactively addressing contamination risks.

Michelle Heiter, laboratory and quality control specialist, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs Company, discuss how to effectively use contamination control strategies in your operations.