#and21
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Heyo! I’m GenderlessGae. Im a 23 year old they/them Agender but AFAB (I also prefer my RP partners to be AFAB and21+) I’m currently looking for long term partners to RP a couple MxM ships such as:
Kylo Ren x General Hux (Star Wars)
Eddie Munson x Steve Harrington (Stranger Things (Prefer to be Eddie)
Aziraphale x Crowley (Good omens) (Prefer to be Aziraphale)
Castiel x Dean Winchester (Prefer to be Dean Winchester) (Supernatural)
I’m hoping for a wholesome romance/Slice of life rp where everyone can have a happy ending and possibly a little family. I’m perfectly fine with smut. My responses are usually a paragraph or two long. (More if I’m inspired) I RP in third person. My time zone is EST and I can respond to RP every day and most of th except when I have things to get done or need to sleep. Please also be active and explain if your busy. Feel free to send me a message or like the post and I'll reach out to you!
.
#twenty-one and over#star wars#star wars roleplay#star wars rp#stranger things#stranger things roleplay#stranger things rp#good omens#good omens roleplay#good omens rp#supernatural#supernatural roleplay#supernatural rp
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Experience the magic of Madchella at Scintillation which is scheduled on 20 and21 September
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Feeling Kosie with Katy ❤ we know how to throw a party 🎉 #kosienightin #comeoneileen #feeling22 #and21 (at Birmingham, United Kingdom)
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19, 20 and21 for the music asks!!
Aaahhh thanks for asking!!!!
19. the last song you had stuck in your head
Feed the Ground by Periphery
20.�� a song you’re dying to master all the words to
I, The Mask by In Flames
21. a song that you could SLAY at karaoke
Follow Me by In Flames
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6/21🔔金🔔
TOKYO Under Land
@kawaiimonstercafe
DragQueen&PoleDancer&Dancer&you
19:30 OPEN
show
20:00 and21:20
💋リル・グランビッチ
💋ブイヤベース
✨RYOTA
���️ちびもえこ
🍣寿司GIRLS
(SAYANINJA+遥+kohamikk)
📀DJ Cloudom
💰2000円 1D
💰3500円 All you can drink
🆔minimum age 20+
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My CHARA! Haha i didn't really change much from how Toby fox made them. (I drew them as 5,15,and21 yrs old in this haha) i ALSO made a unique knife for them/her!
The knife is a army survival knife and the blade is made out of the "9"s from the attacks in the game. And the 9s kinda float off of it like "the numbers" you see in call of duty black ops 1 (campaign mode) haha (◍•﹏•) yay
#undertale chara#chara undertale#chara (undertale)#chara dreemurr#chara#chara yukino au#yukino chara#yukino (undertale)#yukino in underground#yukino#undertale#undertale oc
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The United States equities markets and the crypto markets are most likely to stay unstable in the near term due to the fact that traders stay anxious about the size of the next Federal Reserve rate trek on Sept. 20 and21 While the bulk prefers a 75 basis point rate walking, according to the CME FedWatch Tool, some experts anticipate the Fed to trek rates by 100 basis points, the very first such circumstances because the early 1980 s. Many anticipate Bitcoin ( BTC) to continue its slide and drop listed below the June low in the future. Anything is possible in the markets, numerous times, the markets do not require the bulk. If the Fed does not shock the marketplaces, traders who might beware and resting on the sidelines might leap right back in, leading to a short relief healing. Daily cryptocurrency market efficiency. Source: Coin360 Bear markets provide a chance for financiers to build up in the long term. It is useless to capture the bottom, for this reason, traders might watch to begin building up throughout durations of severe pessimism. A strong stomach is required to tide over the volatility however the ones who do that are most likely to benefit when the next bull run starts. Could Bitcoin and altcoins stage a turn-around or is a much deeper decrease possible? Let's study the charts of the top-10 cryptocurrencies to learn. BTC/USDT Bitcoin has actually remained in a strong drop for numerous months. Purchasers began a healing from the June low at $17,622 and pressed the cost above the 200- week basic moving average (SMA) however they might not sustain the greater levels. BTC/USDT day-to-day chart. Source: TradingView The bulls once again attempted to press the rate above the 200- week SMA recently however the bears held their ground. This reveals that bears are protecting the 200- week SMA with vitality. This level ends up being an essential resistance to see for on the benefit. On the disadvantage, the bulls are anticipated to strongly safeguard the assistance at $17,622 The very first indication of strength will be a break and close above $20,000 That will recommend a range-bound action for the BTC/USDT set in between $17,622 and $25,211 A pattern modification will be indicated after purchasers move the cost above $25,211 The set might then rally to $32,000 Conversely, if bears sink and sustain the cost listed below $17,622, it might signify the resumption of the drop. The set might then decrease to $14,000 ETH/USDT The bears have actually been protecting the 20- week rapid moving average (EMA) ($ 1,732) for the previous couple of weeks. This recommends that the belief in Ether ( ETH) stays bearish and traders are offering on rallies. ETH/USDT day-to-day chart. Source: TradingView The ETH/USDT set refused dramatically from the 20- week EMA recently and has actually reached the 200- week SMA ($ 1,283). Purchasers are anticipated to safeguard this level strongly. The bulls will need to press and sustain the cost above the 20- week EMA to suggest that the bears might be losing their grip. A prospective pattern modification might be signified on a break above $2,030 Till then, the bears are most likely to offer on every rally. If the cost breaks listed below the 200- week SMA, the selling might magnify and the bears will attempt to pull the cost to the June low of $881 This is a crucial level for the bulls to protect since a break listed below it might lead to panic offering. BNB/USDT BNB is among the outperformers amongst the significant cryptocurrencies as it is trading well above its 200- week SMA ($175). Purchasers pressed the rate above the 20- week EMA ($295) however they might not build on this strength. The bears stalled the healing at $338 and pulled the cost back listed below the 20- week EMA. BNB/USDT everyday chart. Source: TradingView Since then, the bears have actually warded off numerous efforts by the bulls to drive the rate back above the 20- week EMA. This suggests that bears are offering the rallies to the 20- week EMA.
The bears will try to sink the BNB/USDT set to the 200- week SMA, which is most likely to draw in strong purchasing by the bulls. The very first indication of strength will be a break above the 20- week EMA. That might clear the course for a retest of $338 The bulls will need to clear this overhead obstacle to recommend the start of a brand-new up-move. XRP/USDT Ripple ( XRP) has actually been combining in a sag for the previous couple of weeks. Purchasers tried to press the rate above the resistance of the variety at $0.41 recently however the bears effectively protected the level. XRP/USDT day-to-day chart. Source: TradingView The sellers will attempt to pull the cost to the assistance at $0.30 This stays the crucial level to watch on since if bears sink the rate listed below $0.30, the XRP/USDT set might start the next leg of the drop. The set might then decrease to $0.24 and later on to $0.17 The 20- week EMA is flattening out, suggesting that the selling pressure might be deteriorating. If the cost rebounds off $0.30, the set might extend its stay inside the variety for a couple of more days. Purchasers will need to press and sustain the rate above the 200- week SMA ($ 0.48) to show that the set might have bottomed out. ADA/USDT Cardano ( ADA) has actually been trading listed below the moving averages for the previous couple of weeks. Efforts by the bulls to press the rate above the 200- week SMA ($ 0.57) were met strong selling by the bears. ADA/USDT day-to-day chart. Source: TradingView Although the bulls have actually held the $0.40 assistance for the previous numerous weeks, the failure to press the cost above the 200- week SMA shows that bears are offering on rallies. The bears will attempt to sink the cost listed below the assistance at $0.40 If they prosper, the ADA/USDT set might resume its drop. The next assistance on the drawback is $0.33 and after that $0.28 If bulls wish to prevent this disaster, they will need to rapidly press the cost above the 200- week SMA. The bears might once again try to position a strong difficulty at $0.70 however if bulls conquer this barrier, the set might show the start of a brand-new uptrend. The set might initially increase to the 50- week SMA ($ 0.96) and afterwards to $1.25 SOL/USDT Solana ( SOL) rallied from the June low of $26 however the healing died near $48 The failure of the bulls to press the rate to the 20- week EMA ($46) recommends that bears are offering on small rallies. SOL/USDT everyday chart. Source: TradingView The bears will attempt to pull the cost to the essential assistance of $26, which has actually not been checked considering that June. If this assistance fractures, the selling might get momentum and the SOL/USDT set might drop to $20 The bulls are most likely to safeguard this level strongly. Alternatively, if the cost shows up from the existing level or rebounds off $26, the bulls will once again attempt to drive the set to the overhead resistance at $48 Purchasers will need to clear this barrier to show the start of a brand-new uptrend. The set might then try a rally to $78 DOGE/USDT Dogecoin ( DOGE) recuperated from $0.05 in June and reached the 20- week EMA ($ 0.08) in August however the bulls might not press the cost above this resistance. The bears strongly protected the level and are attempting to sink the rate back to $0.05 DOGE/USDT day-to-day chart. Source: TradingView If the $0.05 assistance paves the way, the DOGE/USDT set might resume its sag. The next assistance on the disadvantage is at $0.04 however if bulls stop working to protect this level, the selling might heighten and the set might collapse listed below $0.01 There is a little ray of expect the bulls since the RSI is trying to form a favorable divergence. This recommends that the selling pressure might be minimizing. If the rate rebounds off $0.05, the bulls will once again attempt to move the set above $0.09 If that takes place, the set might increase to the 50- week SMA ($ 0.13).
Related: XRP rate threats 30% decrease regardless of Ripple's legal win potential customers DOT/USDT Polkadot ( DOT) has actually been combining in between $6 and $10 for the previous couple of weeks. Normally in a variety, traders purchase the dips to the assistance and offer near the overhead resistance. DOT/USDT day-to-day chart. Source: TradingView If the rate rebounds off the $6 assistance with strength, it will recommend that purchasers are building up on dips. That might keep the DOT/USDT set stuck inside the variety for some more time. The longer the rate trades inside a variety, the more powerful will be the ultimate breakout from it. If purchasers move the cost above $10, it will recommend that the drop might be ending. That might clear the course for a possible rally to the 50- week SMA ($19). Contrarily, if the cost slips listed below the $6 assistance, the set might begin the next leg of the sag. The set might then drop to the $3.50 to $4 assistance zone. MATIC/USDT Polygon ( MATIC) went up dramatically from $0.31 in June and broke above the 20- week EMA ($ 0.87) however the purchasers might not extend the healing. The bears stalled the relief rally at $1.05 and pulled the rate back listed below the 20- week EMA. MATIC/USDT everyday chart. Source: TradingView The bulls once again attempted to thrust and sustain the cost above the 20- week EMA recently however the bears did not relent. They offered strongly and have actually pulled the cost to the instant assistance of $0.72 If this assistance breaks down, the MATIC/USDT set might move to $0.45 and after that to $0.31 On the contrary, if the rate increases from the present level and breaks above the 20- week EMA, the set might challenge the overhead resistance at $1.05 A break and close above this level will recommend that the sag might be over. The cost might then rally to the 50- week SMA ($ 1.31) and after that to $1.75 SHIB/USDT Shiba Inu ( SHIB) rallied greatly from its June low and increased above the 20- week EMA ($ 0.000013) in August. The breakout showed to be a bear trap as the cost turned down from $0.000018 and slipped back listed below the 20- week EMA. SHIB/USDT everyday chart. Source: TradingView Even though the cost has actually been trading listed below the 20- week EMA, the bulls have actually not permitted the SHIB/USDT set to retest the June low at $0.000007 This suggests that purchasers are trying to form a greater low. The very first indication of strength will be a break and close above the 20- week EMA. The set might then rally to $0.000018 If bulls drive the cost above this resistance, it will recommend a possible pattern modification. The set might then rise to $0.000030 This favorable view might revoke if the cost continues lower and breaks listed below $0.000007 That might sink the set to $0.000005 The views and viewpoints revealed here are exclusively those of the author and do not always show the views of Cointelegraph. Every financial investment and trading relocation includes danger. You must perform your own research study when deciding. Market information is supplied by HitBTC exchange. Read More
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HDFC solitaire credit card
Have you ever been immersed in the pool of rewards? If not, then this topic would be a thing of attraction. Moderate charges, huge collection rewards, shopping benefits, and more features are flooded in HDFC Solitaire credit card. This card is considered to be one of the best credit cards in the fees segment. So, let’s dig into the topic- “HDFC Solitaire credit card and its review in 2021”.
Key-Highlights
Eye-catching features are always there –
Aggressive rewards attract new customers quickly.
Shopping vouchers are there for shopping lovers.
1% fuel surcharge and travel benefits.
No liability if you lose the card!
Rewards
#footable_8197, #footable_8197 table { background-color: rgba(255, 255, 255, 1) !important; color: rgba(37, 35, 35, 1) !important; border-color: !important; } #footable_8197 thead tr.footable-filtering th { background-color: !important; color: !important; } #footable_8197:not(.hide_all_borders) thead tr.footable-filtering th { border : 1px solid transparent !important; } #footable_8197 .input-group-btn:last-child > .btn:not(:last-child):not(.dropdown-toggle) { background-color: !important; color: !important; } #footable_8197 tr.footable-header, #footable_8197 tr.footable-header th, .colored_table table.ninja_table_pro.inverted.table.footable-details tbody tr th { background-color: rgba(22, 1, 44, 1) !important; color: rgba(251, 248, 248, 1) !important; } #footable_8197 tbody tr:hover { background-color: !important; color: !important; } #footable_8197 tbody tr:hover td { border-color: !important; } #footable_8197 tbody tr:nth-child(even) { background-color: rgba(181, 240, 255, 1) !important; color: !important; } #footable_8197 tbody tr:nth-child(odd) { background-color: !important; color: !important; } #footable_8197 tbody tr:nth-child(even):hover { background-color: !important; } #footable_8197 tbody tr:nth-child(odd):hover { background-color: !important; } #footable_8197 tfoot .footable-paging { background-color: rgba(135, 200, 210, 1) !important; } #footable_8197 tfoot .footable-paging .footable-page.active a { background-color: !important; } #footable_8197:not(.hide_all_borders) tfoot tr.footable-paging td { border-color: !important; }
Features And Benefits
1. Rewards program: You can check it at the previous point where I have discussed it in detail. Starting from milestone benefits to grocery items and other expenses, you will get attractive rewards.
2. Don’t worry if you lose!: Lost your card? Don’t be panicked or worried – report the bank immediately about the loss, and you will have no responsibility on how many fraud transactions have occurred or not.
3. Happy shopping: Now you can enhance your shopping experience better because by using this credit card, you will avail shopping Vouchers from ShopperStop worth Rs 1000 – but, remember, you have to expend an amount of Rs 75000 during 6 months, and this voucher can be availed only 2 times in a year.
4. Travel more: By redeeming the rewards, you can earn flight distances or Airmiles, so fly high in domestic flight airlines distances only!
5. Waive off fuel charges: Every time you refuel your vehicle, you will get a 1% fuel surcharge waived off – but remember, the maximum waived off money is Rs 250.
6. Transactions are safe! Like every other credit card, this card also comes with an in-built chip that provides more security on every transaction at chip and non-chip POS terminals.
6. Revolving credit limit facility is another unique feature.
7. You can enjoy 50 days grace period from the date of issuance of the card.
Fees
#footable_8197, #footable_8197 table { background-color: rgba(255, 255, 255, 1) !important; color: rgba(37, 35, 35, 1) !important; border-color: !important; } #footable_8197 thead tr.footable-filtering th { background-color: !important; color: !important; } #footable_8197:not(.hide_all_borders) thead tr.footable-filtering th { border : 1px solid transparent !important; } #footable_8197 .input-group-btn:last-child > .btn:not(:last-child):not(.dropdown-toggle) { background-color: !important; color: !important; } #footable_8197 tr.footable-header, #footable_8197 tr.footable-header th, .colored_table table.ninja_table_pro.inverted.table.footable-details tbody tr th { background-color: rgba(22, 1, 44, 1) !important; color: rgba(251, 248, 248, 1) !important; } #footable_8197 tbody tr:hover { background-color: !important; color: !important; } #footable_8197 tbody tr:hover td { border-color: !important; } #footable_8197 tbody tr:nth-child(even) { background-color: rgba(181, 240, 255, 1) !important; color: !important; } #footable_8197 tbody tr:nth-child(odd) { background-color: !important; color: !important; } #footable_8197 tbody tr:nth-child(even):hover { background-color: !important; } #footable_8197 tbody tr:nth-child(odd):hover { background-color: !important; } #footable_8197 tfoot .footable-paging { background-color: rgba(135, 200, 210, 1) !important; } #footable_8197 tfoot .footable-paging .footable-page.active a { background-color: !important; } #footable_8197:not(.hide_all_borders) tfoot tr.footable-paging td { border-color: !important; } #footable_8198, #footable_8198 table { background-color: rgba(255, 255, 255, 1) !important; color: rgba(37, 35, 35, 1) !important; border-color: !important; } #footable_8198 thead tr.footable-filtering th { background-color: !important; color: !important; } #footable_8198:not(.hide_all_borders) thead tr.footable-filtering th { border : 1px solid transparent !important; } #footable_8198 .input-group-btn:last-child > .btn:not(:last-child):not(.dropdown-toggle) { background-color: !important; color: !important; } #footable_8198 tr.footable-header, #footable_8198 tr.footable-header th, .colored_table table.ninja_table_pro.inverted.table.footable-details tbody tr th { background-color: rgba(22, 1, 44, 1) !important; color: rgba(251, 248, 248, 1) !important; } #footable_8198 tbody tr:hover { background-color: !important; color: !important; } #footable_8198 tbody tr:hover td { border-color: !important; } #footable_8198 tbody tr:nth-child(even) { background-color: rgba(181, 240, 255, 1) !important; color: !important; } #footable_8198 tbody tr:nth-child(odd) { background-color: !important; color: !important; } #footable_8198 tbody tr:nth-child(even):hover { background-color: !important; } #footable_8198 tbody tr:nth-child(odd):hover { background-color: !important; } #footable_8198 tfoot .footable-paging { background-color: rgba(135, 200, 210, 1) !important; } #footable_8198 tfoot .footable-paging .footable-page.active a { background-color: !important; } #footable_8198:not(.hide_all_borders) tfoot tr.footable-paging td { border-color: !important; }
Who should opt for this card?
Fortunately, HDFC Bank has opened the opportunity to common people for applying for this card. It did so by making the fees much lower than others. At first sight, one can easily be impressed by its features and benefits. Also, this card could be the best option for shopping lovers. And yes, the travel lovers will get airmiles but not too much – still it is worthy at as compared to its fees,
Eligibility Criteria And Documents Required
You have to be an Indian.
Being self-employed, your age should lie between 21 years to 65 years and21 years to 60 years for being a salaried employee.
And, of course, a good source of income is judged as a top priority.
Documents Required:
Here are the list of the following documents –
Identity proof– you can choose any of the following- PAN card, AADHAR card, Voter Id slip as proof.
Address/residence proof– An address proof is also required. You can choose any of the following-ration card bills of the telephone exchange, gas connection bill, electric bill, or anything.
Income proof – Another important document is income proof. You can show the Latest pay slip of three months, Form 16, or anything as income proof.
How to check application status?
Whether you have applied for the card online or offline, you can check the application progress by visiting their website. There you can see or track your application process. Thus, the process saves both time and energy!
Statement
The credit card statements record all the transactions you have made via this card. So, if you want, you can check the transaction history, which is very useful for making a remainder on the repayment schedule. By the way, you can access the statement from the bank’s website itself.
How you can pay the bill?
There are many payment options, including other bank’s credit cards. Most probably, the auto pay bill is accepted. And, of course, the traditional cash/ cheque system is always available.
So, pay your dues and bills within the deadline, so you do not have to pay extra charges!
How to apply for this card?
Go to the official website www.hdfcbank.com. There will be some questions which require some details. Fill very carefully.
On the second step, some other personal details (used to verify you) have to be filled in – mobile number, PAN number, pin code, Net annual income and much more. You should better have all documents with you to see and copy the details side by side.
Fill up everything in the form. Point to be noted that your application will be cancelled if you provide any false information in the form. And yes, before submitting, read all the terms and conditions carefully.
Not everything about the application process is required for elaboration because you have to fill it according to your condition and details. Fill in the form and enter the next step by clicking on a button that may appear at the bottom of the page. Be very careful while giving information – because the application process will be rejected if you provide false information.
Frequently Asked Questions
Time for doubt clearing!!!
1. What to do if I lost the card?
You have to inform the bank immediately about the loss of your card, and the bank will block your card, or you will be provided with a new card. But you have to pay the fees.
2. What is the credit limit of this card?
Unfortunately, no bank discloses this matter. You will get to know when you are using this card because the credit limit of a card depends on many factors, including your income criteria, usage pattern, credit history, credit score and much more. So it varies from person to person.
3. What to do if I want to pay the bills from other banks which is not listed?
Generally, a significant collection of banks are on the list. But if you still facing the problem, you can contact customer care.
4. How long it takes to credit cash on my account?
Except for weekends, it would take almost 2 – 3 days to be credited to your account.
Final Talk
After reading the whole article, you can understand what I meant to say. Neither you can neglect the disadvantages, nor you can deny by seeing the advantages only. What you can do is – you can tally the rewards/fees ratio and then take the decision.
I have tried to make you understand everything in a single article, hope you like it – see you later!
source https://invested.in/hdfc-solitaire-credit-card/
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Dogecoin Price Predictions for Future / Crypto day trading and daily cryptocurrencies exchange
hello everyone. before moving on to the video we ask you to support us and subscribe to our channel, please. Dogecoin retraces the initial spike to 0.0597 while easing to 0.0560during early Monday. Even so, the cryptocurrency pair stays near the key resistances on Tesla’s owner’s optimism for DOGE. In contrast to Musk’s favor for Dogecoin, the world’s second-richest man admits that bitcoin and Ethereum ‘seem high’.
While the market reaction on bitcoin and Ethereum has been mild, the Dogecoin jumped from 0.0544to 0.0597 following the tweets. Even so, the Dogecoin bulls need to cross a descending resistance line from February 07 and21-day SMA, near 0.0585-90, to gain the market’s confidence in witnessing the 0.1 thresholds. Alternatively, 50% and 61.8% Fibonacci retracement of late January run-up, respectively around 0.

0470and 0.0375, will be the key to stop the Dogecoinbears ahead of 50-day SMA, at 0.0317 now.DOGE bulls struggle to overcome a three-week-old resistance line, 21-day SMA. Bearish MACD favors further consolidation of gains towards the key Fibonacci retracement levels. Bulls can eye $0.1 beyond immediate resistance breakout. Overall, DOGE/USD is up for consolidating the wild gained marked a few weeks back.
However, bulls shouldn’t be disappointed as fundamentals favor the coin. Subscribe to our channel and open notifications to learn more about gold, dollar, Euro, commodities, bitcoin, altcoin, cryptocurrencies, and other investment tools. n this video references an opinion and is for information purposes only. It is not intended to be investment advice. Every investment and trading move involves risk, you should do your own research while making a decision.
Read More: Revealed The Next Big Altcoins & Airdrops!!
via Dogecoin Price Predictions for Future / Crypto day trading and daily cryptocurrencies exchange
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How Trustworthy Are the Numbers On CCP Virus Cases? #CCPVirus #coronavirus #China 3.24.20
https://www.youtube.com/watch?v=IBGkdLCRkg4
Crossroads with JOSHUA PHILIPP
There are drastically different numbers from different countries when it comes to the CCP Virus, and its rate of infection and death rate.
AND
21 Million Fewer Cellphone Users in China May Suggest a High CCP Virus Death Toll
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#65 and21
65. Is there one person in your life that can always make you smile? Yes always 21. Do you miss anyone? Yeah I miss the person that always puts a smile on my face
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Design and development of combination products | operonstraegist
Combination product
as indicated by the Central of Federal Regulation CFR is expressed as a product that includes a medical device /or a medication/or a biologic consolidating any two of these classifications and at some point even every one of the three. The well-known term of combination product is the drug eluting stent (DES) which is a scaffold covered with a drug to prevent scar tissue from developing in the supply artery. Most of the individuals have a constrained perspective on combination products. There are combination products under development today that includes a lot a larger number of things than just drugs, biologics, and medical device. They include foods, they include nutraceuticals, and cosmetics agents or supposed as cosmeceuticals.Combination Products (e.g. Drug, device combination products like prefilled syringes, applicators of the tropical products) manufactures shall have adequate design and development activity done so as to prove the adequacy of the safety and efficacy of the product. The design and development activity is the systematic methodology, which establishes the proper design and development of the products. Many of the customer complaints and 483’s in case of the medical devices or combination devices are contributed to the improper of the design and development control activity. The design and development requirements of the product are described in
ISO 13485: 2016
and
21 CFR Part 820
also.
Combination Products Project Development Process & Design Control
The Pharmaceutical organization which manufacturers the combination products are expected to implement the
21 CFR Part 210 and 211
and21 CFR Part 820 for their manufacturing sites of the combination products. At the end of the design Phases, the DHF is compiled and shall be presented during the audits. The DMR shall be extracted from the DHF for the routine use and the tech transfer. The requirements mentioned in the DMR shall be used to create the DHR to demonstrate the routine production and compliances. As per the requirements of the ISO 13485:2016, the medical device file shall be established. The complexity of the design procedure is dependent on the Product complexity and intended use. The design control is a vital part as far as the Quality Management System goes.
Each manufacturer of a medical device shall establish and maintain procedures to
Control the design of the device
Ensure that specified design requirements are met
CAPA Management For Combination Products
CAPA management
of drugs and device combination products are as follow:To ensure that devices meet a requirement of Combination Products
Users’ needs and intended uses
Requirements and Specifications
The regulatory pathway for combination products
Can be reproducibly and reliably manufactured, serviced and/or installed.
Tools for archiving purpose of combination products
Establish design control procedures.
Develop plans for Design Projects(Include interfaces between R&D and other units)
Identify design inputs requirements and high-level specifications for the device
Develop design outputs (to final specifications)
Design Verification through measurement, analysis, test or inspection that all design outputs fulfil input requirements.
Transfer outputs to production
Design Validation that the device performs and functions as intended and as users need an expert.
Control changes during design and development and to existing devices Document design activities in the design history file.
Drug-Device Combination (DDC) as per MDR for CE Marking
Integral DDCs are products falling under the second sub-paragraphs of both Article 1(8) and Article 1(9) 62 of the Regulation (EU) 2017/745 on medical devices (the MDR).Generally, these devices have measuring, metering or delivery functions.Examples of medical devices in integral DDCs are:
Devices for delivery to the site of action e.g. the dropper on the top of the container with eye drops the mouthpiece on the top of spray cans for throat sprays.
Single-dose pre-filled syringes, pens and injectors.
Multi-dose pens and injectors containing a pre-filled cartridge where the cartridge cannot be replaced, and the pen is not designed for subsequent use with a new cartridge.
Drug-releasing intra-uterine devices; pre-assembled, non-reusable applicators for vaginal tablets.
Dry powder inhalers that are assembled with the medicinal component and ready for use with single or multiple doses but cannot be refilled when all doses are taken.
Implants containing medicinal products whose primary purpose is to release the medicinal product.
Examples of medical devices in non-integral DDCs are:
Oral administration devices (e.g. cups, spoons, syringes)
Injection needles and filter needles
Refillable pens and injectors (e.g. using cartridges).
Reusable dry powder inhalers; spacers for inhalation sprays
Pumps for medicinal product delivery
Electronic tablet dispensers
Operon Strategist assists companies and medical device manufacturers by providing consultancy services that support the registration of drug-device Combination Products. We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug (21 CFR 210/211), Device (21 CFR 820) and 21 CFR Combination Products (21 CFR Part 4)
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Combination product
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Edinburgh Art Festival 2019 - the numbers paint a pretty picture
Edinburgh Art Festival 2019 – the numbers paint a pretty picture
With world premieres, major retrospectives and work from established and emerging artists among more than 50 exhibitions presented by galleries, pop up venues and historic spaces across the length and breadth of the city, the 16th edition of Edinburgh Art Festival concluded yesterday having recorded over 290,000 attendances.
Over 80% of the programme is free to attend and 21 community groups…
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100 (and21) followers
So looks like I hit 100 followers without realizing it. Even though I don't really post a whole lot of original content anymore. Thanks tho 👍
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The S&P 500 index has actually decreased about 5% today while the Nasdaq Composite is down more than 5.5%. Financiers fear that the Federal Reserve's aggressive rate walkings might trigger a financial recession. The yield curve in between the two-year and 10- year Treasury notes, which is enjoyed carefully by experts for forecasting an economic downturn, has inverted the most because the year2000 Among all the chaos, it is motivating to see that Bitcoin ( BTC) has actually outshined both the significant indexes and has actually fallen less than 4% in the week. Could this be an indication that Bitcoin's bottom might be nearby? Daily cryptocurrency market efficiency. Source: Coin360 On-chain information reveals that the quantity of Bitcoin supply held by long-lasting holders in losses reached about 30%, which is 2% to 5% listed below the level that accompanied Bitcoin's bottom in March 2020 and December2018 This metric recommends that Bitcoin might have more space to fall prior to it bottoms out. Let's study the charts of the S&P 500 index, the U.S. dollar index (DXY) and the significant cryptocurrencies to identify whether the pattern will continue or if a turnaround is most likely. SPX The S&P 500 index (SPX) broke listed below the 3,900 assistance on Sept. 16 and the bears effectively safeguarded the level on retests on Sept. 17 and21 This ends up being a crucial level to keep an eye on as a break above 3,900 will be the very first indication that bulls are on a resurgence. SPX everyday chart. Source: TradingView The downsloping 20- day rapid moving average (EMA) (3,920) suggests a benefit to bears however the relative strength index (RSI) in the oversold area recommends that the index might try a rebound from the strong assistance zone in between 3,715 and 3,636 A weak rebound off this zone will suggest an absence of aggressive purchasing by the bulls. That might increase the possibility of a decrease listed below the essential June low at 3,636 If this assistance collapses, the index might plunge towards 3,325 On the contrary, a strong rebound off the assistance zone might lead to a healing to 3,900 A break above this resistance might signify a prospective pattern modification in the near term. DXY The U.S. dollar index (DXY) has actually remained in a strong uptrend for the previous couple of months. Every dip is being bought strongly and the index continues to scale brand-new heights. Efforts by the bears to require a pattern modification stopped working when the rate rebounded off the 50- day basic moving average (SMA) ($108) on Sept. 13. DXY everyday chart. Source: TradingView After remaining in a tight variety for a couple of days, the index broke out to a brand-new 52- week high up on Sept.21 This resumed the uptrend and the index might next try a rally to 115. The sharp rally of the previous couple of days has actually pressed the RSI into the overbought zone, which recommends a small debt consolidation or correction is possible in the next couple of days. The 20- day EMA (109) is an essential assistance to expect on the drawback since a break listed below it might sink the cost to the 50- day SMA. The bears will need to pull the rate listed below 107 to show a possible pattern modification in the near term. BTC/USDT Buyers have actually been purchasing the dip listed below $18,626 in Bitcoin however the failure to press the rate above the 20- day EMA ($19,841) reveals that bears remain in no state of mind to let go of their benefit. This increases the possibility of a retest of the crucial June low at $17,622 BTC/USDT day-to-day chart. Source: TradingView A break and close listed below $17,622 might develop panic and the BTC/USDT set might plunge to the next significant assistance at $14,500 While the downsloping moving averages show benefit to bears, the favorable divergence on the RSI recommends that the selling pressure might be minimizing. This view might reinforce if bulls drive and sustain the cost above the 20- day EMA.
That might press the cost towards the overhead resistance zone in between the 50- day SMA (21,200) and $22,799 Such a relocation will recommend that the set might continue its bottoming development inside the big variety in between $17,622 and $25,211 for longer. ETH/USDT Ether ( ETH) has actually been trading inside a coming down channel pattern for the previous couple of days. In a channel, traders typically purchase near the assistance and offer near the resistance. ETH/USDT day-to-day chart. Source: TradingView The bears attempted to sink the cost listed below the channel on Sept. 21 however the bulls safeguarded the level effectively. The bulls will attempt to press the cost to the 20- day EMA ($ 1,467) where they might deal with stiff resistance from the bears. If the rate refuses from the present level or the 20- day EMA, it will recommend that the belief stays unfavorable and traders are offering on every small rally. The bears will however attempt to pull the cost listed below the channel and challenge the mental assistance at $1,000 Contrarily, if the cost increases above the 20- day EMA, the set might reach the resistance line of the channel. A break and close above the channel might recommend a possible pattern modification. BNB/USDT BNB has actually been oscillating in between the 20- day EMA ($276) and $258 for the previous couple of days. This reveals that the bulls are safeguarding the instant assistance at $258 however they have actually stopped working to press the rate above the 20- day EMA. BNB/USDT day-to-day chart. Source: TradingView This tight-range trading is not likely to continue for long. If purchasers move the cost above the 20- day EMA, the BNB/USDT set might increase to the resistance line of the coming down channel. The bulls will need to conquer this barrier to recommend that the restorative stage might be over. The set might then try a rally to $338 If the cost denies from the existing level or the resistance line of the channel, the bears will once again attempt to sink the set listed below $258 If they handle to do that, the set might decrease to the assistance line. XRP/USDT XRP broke above the $0.41 overhead resistance on Sept.20 The bears attempted to trap the aggressive bulls on Sept. 21 however the purchasers had other strategies. They bought the dip with vitality and thrust the rate above the overhead resistance on Sept. 22. XRP/USDT everyday chart. Source: TradingView The pattern target of the break from the $0.30 to $0.41 variety was $0.52 and the exact same was reached on Sept.23 This sharp relocation pressed the RSI into the overbought area, recommending a small correction or debt consolidation in the near term. The long wick on the Sept. 23 candlestick reveals profit-booking at greater levels. Usually, after the breakout from a variety, the cost tends to retest the breakout level. In this case, the rate might drop to $0.41 If bulls turn this level into assistance, the XRP/USDT will attempt to resume the up-move. If the rate increases above $0.56, the next stop might be $0.66 On the other hand, a break listed below $0.41 might recommend that the current breakout was a bear trap. ADA/USDT Cardano ( ADA) bounced off the uptrend line on Sept. 22, showing that bulls are protecting this level with vitality. The rate reached near the sag line on Sept. 23 however the long wick on the candlestick reveals that bears are active at greater levels. ADA/USDT day-to-day chart. Source: TradingView The 20- day EMA ($ 0.46) has actually begun to decline and the RSI is simply listed below the midpoint, suggesting a small benefit to bears. If the cost continues lower and plunges listed below the uptrend line, the ADA/USDT set might drop to $0.40 This is an essential level for the bulls to safeguard due to the fact that a break listed below it might resume the drop. If bulls wish to get the edge, they will need to drive and sustain the rate above the sag line. The set might then increase to $0.60 where the bears might once again install a stiff resistance.
Related: XRP hits 13- month high versus Bitcoin with 35% day-to-day rise-- But is a correction inescapable? SOL/USDT Solana ( SOL) has actually been getting squeezed in between the 20- day EMA ($33) and the instant assistance at $30 This shows a state of stability in between purchasers and sellers. SOL/USDT everyday chart. Source: TradingView This unpredictability is not likely to continue for long. The bears will attempt to take control by pulling the rate listed below $30 If that occurs, the SOL/USDT set might drop to the strong assistance at $26 The bulls are anticipated to safeguard this level strongly due to the fact that if this assistance fractures, the SOL/USDT set might witness panic offering and drop towards $20 To revoke this unfavorable view in the short-term, purchasers will need to drive the cost above the moving averages and the overhead resistance at $39 If they prosper, the set might rally to $48 DOGE/USDT Buyers purchased the dip listed below the instant assistance on Sept. 21 however they are having a hard time to sustain Dogecoin ( DOGE) above the 20- day EMA ($ 0.06) on Sept.23 This recommends that bears continue to offer on rallies. DOGE/USDT everyday chart. Source: TradingView The bears will try to increase their benefit by sinking the cost listed below the instant assistance near $0.06 If they do that, the DOGE/USDT set might extend its decrease to the June low at $0.05 This is a critical level due to the fact that a break listed below it might suggest the start of the next leg of the sag. Conversely, if the cost sustains above the 20- day EMA, the set might increase to the 50- day SMA ($ 0.07). If bulls pierce this resistance, the set might rally towards $0.09 DOT/USDT Buyers effectively protected the crucial assistance of $6 on Sept. 21 and 22 however the shallow bounce recommends that need dries up at greater levels. The longer Polkadot ( DOT) trades listed below the 20- day EMA (6.87), the higher the possibility of a break listed below $6. DOT/USDT day-to-day chart. Source: TradingView If bears sink and sustain the rate listed below $6, the selling momentum might get and the DOT/USDT set might resume its drop. The next significant assistance on the disadvantage is at $4. Alternatively, if the rate rebounds off $6 or shows up greatly after breaking listed below the assistance, it will recommend that bulls continue to purchase lower levels. The bulls will need to move the cost above the moving averages to clear the course for a possible up-move to $10, which, once again, is most likely to function as a barrier. The views and viewpoints revealed here are entirely those of the author and do not always show the views of Cointelegraph. Every financial investment and trading relocation includes threat. You ought to perform your own research study when deciding. Market information is supplied by HitBTC exchange. Read More
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Why is Japan 20 and21 when she can perform it around 15th maybe China or another soon
No idea
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